Jeffrey D. Wayne, MD Curriculum Vitae California License #G65909 DEA License #BW1848211 Principal Investigator - Owner

Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Jeffrey D. Wayne, MD Curriculum Vitae California License #G65909 DEA License #BW1848211 Principal Investigator - Owner | Clinical Trials Research

Clinical Trials Research Investigators

160 Gateway Drive, Suite 100 Joseph D. Hobbs, PA-C Lincoln, CA 95648 Robyn Lawrie, NP (916) 434-8230 Phone Sharmila Chatterjee, MD, MPH (916) 434-8237 Fax H. Douglas Cooper, MD (Ophthalmology)

3750 Auburn Boulevard, Suite A Research Coordinators Sacramento, CA 95821 (916) 434-8230 Phone Leesa Koskela, CCRC (Clinical Director) (916) 487-8237 Fax Tammy Ward, CRC Marissa Tangerini, BS, CCRC Stacey Adams, CRC Kari Sue Jones, CCRC Kadijah Washington, CRC

Education

1978-1982 University of Southern California Keck School of Medicine – MD Degree

1974-1978 Emory University Atlanta, GA – BA Psychology

Professional Experience

1999-Present Clinical Trials Research, Owner/Principal Investigator

1992-Present Clinical Trials, Principal Investigator

1989-Present Internal Medicine (Private Practice), Owner

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

2006-2007 Howe Medical Clinic, Medical Director

1997-1999 Sacramento Health and Weight Management, Inc, Medical Director

1986-1989 Faulkner Hospital, ER Attending Physician, Clinical Instructor

Professional Training

1983-1986 Residency – Internal Medicine – Faulkner Hospital Tufts University School of Medicine, Boston, Mass Board Certified in Internal Medicine - 1987

1982-1983 Internship – Family Practice – University of Southern California Presbyterian Intercommunity Hospital Family Medicine Program at Los Angeles County Hospital

Clinical Research Experience

28 years conducting clinical trials as Principal Investigator in multiple therapeutic areas including but not limited to hypertension, diabetes, cardiovascular, respiratory, women’s health, men’s health. Approximately 260 trials completed.

Academic Appointments and Memberships

Present Appointment

2014-Present Volunteer Clinical Faculty, University of California, Davis School of Medicine

Previous Appointments

1999-2016 Office based staff member, Mercy San Juan Hospital

1999-2008 Senior staff member, Sutter Roseville Medical Center

1992-2005 Qualified Medical Examiner, State of California, Industrial Medical Council

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

1999-2008 Medical Director, Eskaton Home Care

1996-1997 Clinical Preceptor, University of San Francisco School of Nursing, Nurse Practitioner Program

1992-1994 Director of Clinical Research, Sutter Medical Group

1991-1993 Clinical Preceptor, University of California, Davis, Medical Center Physician Assistant Program

1989-1999 Senior Staff Member, Mercy American River Hospital and Mercy San Juan Hospital

1986-1989 Clinical Instructor, Tufts University School of Medicine

Clinical Trials

TAP Pharmaceuticals Generalized Anxiety Disorder Study. Double-Blind, Fixed Dose Multicenter Study Comparing XXXX to XXXX and Placebo in Patients with Generalized Anxiety Disorder.

Merck Sharpe and Dohme Ace Inhibitor Cough Study. A Multicenter, Double-Blind, Randomized, Parallel Group Study to Investigate the Incidence of Cough in Patients Receiving XXXX or XXXX who have Reported Cough with an Angiotensin Converting Enzyme Inhibitor.

Norwich-Eaton Urinary Tract Infection (UTI) Study. An Open Label, Multicenter Study to Compare the Safety and Efficacy of XXXX for Seven Days to XXXX for Ten Days in the Treatment of Acute, Uncomplicated Lower Urinary Tract Infections.

Ciba-Geigy Corporation Hypertension Study. A Randomized, Doub1e-B1ind, Parallel Trial Comparing XXXX, XXXX, and XXXX in Patients Age 18-80 Years with Essential Hypertension Inadequately Controlled with XXXX Followed by a Single-Blind Extension of XXXX.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Medeva Hepatitis Study. A Multicenter, Randomized, Double-Blind Study in Normal, Healthy Subjects to evaluate the Efficacy and Safety of Two-Dose, One Month Regimen of XXXX Compared to XXXX and to a Three Dose, Two Month Regimen of XXXX.

TAP Holdings Dyspepsia Study. A Study to Evaluate the Effects of XXXX 30 mg or 15 mg QD versus Placebo in Patients with Non-Ulcer Dyspepsia.

Glaxo Wellcome Chronic Bronchitis Study. A Randomized, Double-Blind Multicenter Comparison of the Efficacy and Safety of XXXX 400 mg or 600 mg Once Daily and XXXX 500 mg Twice Daily in the Treatment of Patients with Acute Bacterial Exacerbations of Chronic Bronchitis.

Novartis Pharmaceuticals Diabetes Study. A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Efficacy, Tolerability and Safety of XXXX Monotherapy, XXXX Monotherapy and a Combination of XXXX and XXXX to Placebo in Subjects with Non- Insulin Dependent Diabetes Mellitus Inadequately Controlled on Diet Alone.

TAP Holdings GERD Study. Study to Evaluate the Effects of XXXX 5 mg QID, 10 mg TID, 20 mg BID Versus Placebo in Females with Non-Erosive Gastroesophageal Reflux Disease.

Kos Pharmaceuticals Lipid Study. A Long-Term, Open-Label, Multicenter Trial of the Safety and Efficacy of Nicostatin in Patients with Dyslipidemia.

Medeva Hepatitis Study. A Multicenter, Long-Term, Follow-up Study of the Duration of Seroprotection After XXXX, and an Open-Label Study of the Efficacy and Safety of a Single Dose of XXXX in Subjects with Low XXXX Values.

Berlex Laboratories Menopause Study. A Multicenter, Double-Blind, Randomized Study of Continuous XXXX Combinations, Compared to Continuous XXXX, to Examine the Safety and Effect on the Endometrium, Symptoms and Bleeding Patterns in Postmenopausal Women.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Merck & Co. Osteoarthritis Study. A Randomized, Double Blind, Multicenter Study to Evaluate the Tolerability and Effectiveness of XXXX 25 mg qd vs XXXX 500 mg bid. in Patients with Osteoarthritis.

Novartis Pharmaceuticals Diabetes Study. A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Evaluate the Efficacy, Safety and Tolerability of Three Fixed Dose Levels of Nateglinide and Placebo in Type 2 Diabetes Mellitus patients with Minimally Elevated Fasting Plasma Glucose Levels.

TAP Pharmaceuticals Irritable Bowel Syndrome (IBS) Study. A Study to Evaluate the Safety and Efficacy of XXXX (30 mg BID, 60 mg BID and 120 mg BID) vs XXXX in Subjects with Irritable Bowel Syndrome.

Novartis Pharmaceuticals Functional Dyspepsia and Delayed Gastric Emptying Study. A Randomized, Double- Blind, Placebo-Controlled, Dose Finding, Multicenter Study to Assess, the Efficacy, Safety and Tolerability of XXXX Given Orally at Three Dose Levels (1 mg, 4 mg or 12 mg), and XXXX in Patients with Functional Dyspepsia (FD) and Documented Normal Gastric Emptying.

Novartis Pharmaceuticals Functional Dyspepsia and Delayed Gastric Emptying Study. A Randomized, Double- Blind, Placebo-Controlled, Dose Finding, Multicenter Study to Assess the Efficacy, Safety and Tolerability of XXXX Given Orally at Three Dose Levels (4mg, 12 mg or 24 mg) and XXXX in Patients with Functional Dyspepsia (FD) and Documented Delayed Gastric Emptying.

Takeda Pharmaceuticals North America Diabetes / CHF Study. A Randomized, Double-Blind, Comparator-Controlled Study of XXXX vs XXXX in the Treatment of Subjects with Type 2 (Non-Insulin Dependent) Diabetes Mellitus and Mild to Moderate Congestive Heart Failure.

Takeda Pharmaceuticals North America Diabetes / Cardiovascular Study. A Randomized, Double-Blind, Comparator-Controlled Study of XXXX vs. XXXX in the Treatment of Subjects with Type 2 (Non-Insulin Dependent) Diabetes Mellitus and Mild Cardiac Disease (NYHA I).

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Bertek Pharmaceuticals Hypertension Study. A Double-Blind, Multicenter, randomized, Placebo Controlled, Parallel Group Study of the Efficacy and Safety of XXX Added to Existing Antihypertensive Treatment in Patients with Mild to Moderate Hypertension.

Eli Lilly Diabetic Peripheral Neuropathy Study. LY333531 Treatment of Peripheral Neuropathy in Patients with Diabetes.

Bristol-Myers Squibb Diabetes Study. A Randomized, Double-Blind, Dose Ranging, Dose Comparison- Controlled Trial to Determine the Safety and Efficacy of XXXX in Patients with Type 2 Diabetes

Solvay Pharmaceuticals Irritable Bowel Syndrome Study. A Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Investigate the Safety and Efficacy of 2 mg TID of Cilansetron over 12 Weeks Followed by a 4-week XXX Treatment Period in Diarrhea-Predominant Irritable Bowel Syndrome Subjects.

Novartis Pharmaceuticals African American Hypertension Study. A Double-Blind, Randomized, Parallel Group Study Comparing the Effects of XXX to XXX in African American Patients with Mild to Moderate Hypertension.

Novartis Pharmaceuticals Impaired Glucose Tolerance (IGT) Study. A Multinational, Randomized, Double-Blind, Placebo-Controlled, Forced-Titration, 2 X 2 Factorial Design Study of the Efficacy and Safety of Long Term Administration of XXX and XXXX in the Prevention of Diabetes and Cardiovascular Outcomes in Subjects with Impaired Glucose Tolerance (IGT).

Novartis Pharmaceuticals Hypertension Study. A Multicenter Prospective, Randomized, Open-Label, Blinded End-Point, Parallel Group Study Comparing the Effects of XXX(5/20mg) to XXXX (5 mg) and XXXX (20 mg) on Systolic Blood Pressure and Pulse Pressure in Patients with Systolic Hypertension.

Takeda Pharmaceuticals North America Congestive Heart Failure Study. A Phase II, Double-Blind, Randomized, Exploratory, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of MCC-135 Comparing QD vs BID Doses in Subjects with Congestive Heart Failure, NYHA Class II/III.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Takeda Pharmaceuticals North America Diabetes Study. A Phase 2, 12-Week, Randomized, Double-Blind, Four-Arm, Placebo- Controlled, Dose-Ranging Study for Safety and Efficacy of XXXX in Type 2 Diabetic Subjects (XXX Treated or Diet-Controlled) as Measured by XXX Control.

Boehringer Ingelheim Pharmaceuticals Hypertension Study. A Prospective, Randomized, Open-Label, Blinded-Endpoint, Parallel Group 6-week Treatment Study Comparing Telmisartan combined with Hydrochlorothiazide (40 mg/12.5 mg or 80 mg/12.5 mg) Tablets with XXX combined with Hydrochlorothiazide (50 mg/12.5 mg) Tablets using Ambulatory Blood Pressure Monitoring in Patients with Mild-to-Moderate Hypertension.

Merck & Co. Diabetes Study. A Multicenter, Double-Blind, Randomized, Placebo-Controlled Parallel Study to Evaluate the Safety and Efficacy of the Addition of XXXX to Patients with Type 2 Diabetes with Inadequate XXXX Control on Combined XXXX and XXXX Therapy.

Novartis Pharmaceuticals Hypertension Study. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study comparing XXXX 150 mg, 300 mg, 600 mg to Placebo and XXXX 150 mg in Patients with Mild-to-Moderate Essential Hypertension.

Bristol-Myers Squibb Diabetes Metformin Add-on Study. A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of XXXX in Combination with Metformin Therapy in Subjects with Type 2 Diabetes Who Have Inadequate XXXX Control on XXXX Alone.

Bristol-Myers Squibb Diabetes Study. A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of XXXX as Monotherapy in Subjects with Type 2 Diabetes Who Have Inadequate XXX Control.

Merck & Co. Metabolic Syndrome Lipid Study. An Extension to: A Multicenter, Double-Blind, Randomized, Placebo- and Active-Parallel Study to Evaluate the Lipid-Altering Efficacy and Safety of XXXX in Patients with Metabolic Syndrome and Dyslipidemia to Determine the Lipid-Lowering Effects of XXXX in Combination With XXXX.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

AstraZeneca Gastric Ulcer Study. A comparative Efficacy and Safety of NEXIUM (XXXX XXX) Delayed-Release capsules (40 mg qd and 20 mg qd) Versus Placebo for prevention of Gastric Ulcers Associated with Daily NSAID use in Patients at Risk.

AstraZeneca Gastric Ulcer Study. A comparative Efficacy and Safety Study of NEXIUM (XXXX XXX) Delayed-Release capsule (40mg qd and 20 mg qd) versus XXX for the Healing of NSAID- associated Gastric Ulcers when daily NSAID use is continued.

Novartis Pharmaceuticals Knee Osteoarthritis Study. A 13-week, Multicenter, Randomized, Double-Blind, Double- Dummy, Placebo-Controlled, Parallel Trial of 2 Different Dose Regimens of XXXX (100 mg od and 200 mg od initial dose for two weeks followed by 100 mg od) in Patients with Primary Knee Osteoarthritis, using XXX (200 mg od) as a Comparator.

Bristol-Myers Squibb Sanofi-Synthelabo Partnership Hypertension Study. Testing the Efficacy and Safety of XXX 150/12.5 mg and XXX 300/25 mg in Patients with Hypertension Uncontrolled on Monotherapy.

Boehringer Ingelheim Pharmaceuticals Hypertension Study. A Randomized, Double-Blind, Double-Dummy, Placebo- Controlled, Forced-Titration, Comparison of XXX HCT (Telmisartan 80 mg / XXX 25 mg) versus XXX HCT (XXX 160 mg / XXX 25 mg) using Seated Trough Cuff Blood Pressure in Patients with Stage 1 and Stage 2 Hypertension.

Novartis Pharmaceuticals Hypertension Study. A Randomized, Double-Blind, Multicenter, Multifactorial, Placebo- Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of XXX (160 and 320 mg) and Hydrochlorothiazide (12.5 and 25 mg) Combined and Alone in Hypertensive Patients.

Bristol- Meyers Squibb Lipid Study. A Randomized, Double-Blind, Dose Ranging, Placebo-Controlled Trial to Determine the Lipid-lowering Efficacy and Safety of XXX Alone and in Combination with XXX in Subjects with Mixed Dyslipidemia.

Takeda Pharmaceuticals North America Diabetes Study. A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of a Combination of XXXX and XXX Compared to Placebo and XXX in the Treatment of Subjects with Type 2 Diabetes Mellitus.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Takeda Pharmaceuticals North America Diabetes Study. A Multicenter, Double-Blind, Randomized, Placebo-Controlled Parallel Safety and Efficacy Study of XXXX in the Treatment of Subjects with Type 2 Diabetes Mellitus.

Bristol-Myers Squibb Diabetes Metformin Add-on Study. A Phase 3, Randomized, Double-Blind, Active Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of XXXX in Combination with Metformin Compared to XXX in Combination with Metformin in Subjects with Type 2 Diabetes who have Inadequate XXX Control on Metformin Therapy Alone.

Wyeth Research GERD Study. Symptom Relief in Patients Suffering from Gastroesophageal Reflux Disease Grade A to D According to Los Angeles (LA) Classification Treated with XXX 40 mg qd or XXX 40 mg qd.

Novartis Pharmaceuticals Dyspepsia Study. A 6-week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to assess the Efficacy and Safety of Oral XXX (6mg bid) and Placebo in Female Patients with Dyspepsia.

Novartis Pharmaceuticals Diabetes Study. A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 24 Weeks Treatment with LAF237 (50mg qd or bid) to Placebo as Add-on Therapy to Glimepiride in Patients with Type 2 Diabetes Inadequately Controlled with Sulfonylurea Monotherapy.

Bristol-Myers Squibb Hypertension Study. Testing the Efficacy and Safety of XXX/HCTZ Combination Therapy as First Line Treatment for Patients with Moderate Hypertension.

Novartis Hypertension Study. Effects of Blood Pressure Reduction on High Sensitivity C- Reactive Protein (hsCRP): A Multicenter, Randomized, Open-Label, 2-Arm Parallel Group Study to Evaluate the Efficacy of Moderate Vs. Aggressive Antihypertensive Therapy with XXX® and XXX HCT® to Reduce Blood pressure and Plasma hsCRP levels in Patients with Stage 2 Hypertension.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Novartis Metabolic Syndrome Study. A 16 week, Randomized, Double-Blind, Active-Controlled, Parallel Group Study to Evaluate the Effect on Insulin Sensitivity of XXX (320mg) and Hydrochlorothiazide (25mg) Combined and Alone, in Patients with Metabolic Syndrome.

Alteon Hypertension Study. Effect of XXX (ALT-711) in Combination with Fixed-Dose XXX Therapy on Systolic Blood Pressure in Hypertensive Patients.

Amgen Cardiovascular Study. Trial to Reduce Cardiovascular Events with XXX® Therapy.

Merck Hypertension Study. A Randomized, Double-Blind, Parallel-Filter Study to Evaluate the Antihypertensive Efficacy and Safety of XXX-HCTZ Combination as Compared to XXX Monotherapy in Patients with Essential Hypertension.

Kendle International Inc. Abdominal Pain Study. A double blind, placebo controlled, randomized, parallel group study of the efficacy and safety of oral doses of 20 mg XXX XXX when used on-demand for up to 7 episodes of self-reported abdominal pain, cramping and discomfort in an OTC-like study population.

Bristol-Myers Squibb Diabetes Study. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of XXXX in Combination with XXXX in subjects with Type 2 Diabetes who have Inadequate Glycemic Control on XXX Alone.

Boehringer Ingelheim Pharmaceuticals Inc. Hypertension Study. A randomized, Double-Blind, Double-Dummy, Placebo-Controlled 3x4 Factorial Design Trial to Evaluate XXX 20 and 80 mg Tablets in Combination with XXX 1.25, 10 and 20 mg Capsules After Eight Weeks of Treatment in Patients with Sate I or II Hypertension, With an ABPM Sub-Study.

Novartis Pharmaceuticals Hypertension Study. An 8-week, Multicenter, randomized double blind, parallel-group study to evaluate the efficacy and safety of the combination of XXXX/HCTZ XXX compared to XXX/HCTZ, XXX/XXX, and HCTZ/XXX in patients with moderate to severe hypertension.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Sankyo Pharma Development Diabetes Study. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of XX-XXX as Monotherapy for Type 2 Diabetes.

Palatin Technologies, Inc. Hypertension Study. A Randomized, Double-Blind Multicenter, Placebo-Controlled, Parallel Study Evaluating the Safety of PT-141 in Subjects with Controlled Essential Hypertension (Stage 1 or 2).

Bristol-Myers Squibb Pharmaceutical Research Institute Diabetes Study. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of XXXX in Combination with XXX in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on XXXX Alone.

BioMarin Pharmaceutical, Inc. Hypertension Study. A Phase 2, Multicenter, Randomized, Double-Blind, Placebo- Controlled, Parallel Study of the Effects of 6R-BH4 in Blood Pressure in Subjects with Poorly Controlled Systemic Hypertension.

Boehringer Ingelheim Pharmaceuticals, Inc. Abdominal Pain Study. A Double-Blind, Placebo Controlled, Randomized, Parallel Group Study of the Efficacy and Safety of Oral Doses of XXX when Used and Based on a Patients Decision to Self-Medicate for Up to 7 Episodes Over a Period of 6 Weeks for the Treatment of Occasional Episodes of Self-Reported Abdominal Pain or Discomfort Associated with Cramping in an OTC- Like Study Population.

Kemia Lipid Study. A Phase 2 Randomized Double-Blind Placebo-Controlled Study of XXXX in Patients with Dyslipidemia.

Takeda Pharmaceuticals North America Diabetes Study. A Phase II, Double-Blind Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate Treatment with XXXX in Subjects with Type 2 Diabetes.

Calpis Hypertension Study. A Prospective, Two-Phase Randomized, Open-Label, Blinded End-Point Parallel Group, Dose Response Study to Evaluate the Safety and Efficacy of XXXX, XXX, XXX or Placebo in Patients with Sate I or Stage II Hypertension.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Novo Nordisk Inc. Diabetes Insulin Study. A 26- Week, Open-Label, Multicentre, Randomised, Parallel Trial to Investigate Efficacy and Safety of Inhaled Mealtime Insulin with XXX plus XXX versus XXX alone in Type 2 Diabetes.

Novartis Pharmaceuticals Diabetes Study. A Multicenter, randomized, open-label, active controlled, parallel arm study to compare the efficacy of 12 weeks of treatment with XXX 100 mg, qd to XXXX (XXX) as add-on therapy in patients with type 2 diabetes inadequately controlled with XXX Monotherapy in a community-based practice setting.

Daiichi Sankyo Inc. Diabetes Hypertension Study. A Prospective, Open Label, Single Arm Study to Evaluate the Safety and Efficacy of an XXX XXX Based Treatment Regimen in Type II Diabetic Patients with Hypertension.

Sciele ™ Pharma, Inc. Lipid Study. A Multicenter, Prospective, Longitudinal, Randomized, Double-Blind, Phase III Study to Evaluate the Efficacy and Safety of Daily Administration of XXX 40 mg or XXX 160 mg or XXX (combination of XXX and XXX 40/160 mg) for 12 Weeks Followed by a 52-Week Open-Label Safety Phase of the XXX alone in the Treatment of Combined Hyperlipidemia.

Forest Hypertension Study. A Prospective, Randomized, Open-Label, Parallel Group Study to Compare the Tolerability of Nebivolol to Other Beta Blockers in Patients With Stage I Or Stage II Hypertension.

Forest Hypertension Study. Tolerability of Nebivolol Compared with Metoprolol ER In Patients with Mild to Moderate Hypertension Taking Hydrochlorothiazide.

Shionogi USA Inc. Obesity Study. A Double Blind, Multicenter, Randomized, Parallel-Group, Year Long Study to Assess the Efficacy and Safety of 0,800 or 1600 mg/day of S-2367 Administered Orally Once Daily with a Reduced Calorie Diet in Obese Males and Females.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

2008

Pharmacopeia (Ligand) Hypertension Study. A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of a Novel Dual Angiotensin and Endothelin Receptor Antagonist (PS433540) in Subjects with Stage I and II Hypertension.

Pharmacopeia (Ligand) Hypertension Study. A randomized, double-blind, placebo and active controlled, parallel group to evaluate the dose-related efficacy and safety of PS433540 in subjects with hypertension.

Abbott Lipid Study. A Multicenter Study Comparing the Safety and Efficacy of ABT-335 and Rosuvastatin Calcium Combination Therapy to Monotherapy in Subjects with Dyslipidemia.

Abbott Lipid Study. A Randomized, double-blind, prospective study comparing safety and efficacy of ABT-335 in combination with atorvastatin and ezetimibe to atorvastatin in combination with ezetimibe in subjects with combined (atherogenic) dyslipidemia.

Pfizer Arthritis/Cardiovascular Study. A Randomized, Double-Blind, Parallel-Group Study of Cardiovascular Safety in Osteoarthritis or Rheumatoid Arthritis Patients with or at High Risk for Cardiovascular Disease Comparing XXXX with XXXX and XXXX.

Forest Hypertension Study. Metabolic Effects of Nebivolol HCL Compared with Metoprolol ER in Hypertensive Patients with Impaired Glucose Tolerance or Impaired Fasting Glucose.

Pfizer Fibromyalgia Study. A 14 Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of [S,S]- Reboxetine Administered Once Daily in Patients with Fibromyalgia.

Takeda Hypertension Study. A double blind, randomized, placebo-controlled study to evaluate the efficacy and safety of TAK-491 when co-administered with amlodipine 5 mg in subjects with essential hypertension.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Novartis Hypertension Study. A Phase 4, 54-week, mild to moderate systolic or diastolic HTN, GI safety and tolerability of Aliskiren.

Novartis Hypertension Study. A Phase 4, 12-week study, moderate to severe systolic HTN comparing two doses of Exforge added to Olmesartan.

Sankyo Hypertension Study. A Phase 4, 52-week study comparing 2 vs. 3 drug therapies for moderate to severe combined systolic and diastolic HTN.

Forest Hypertension Study. A Phase 4, 18-week study, to assess safety and efficacy with Nebivolol compared to placebo when added to a stable regimen of Lisinopril or Losartan in patients with moderate systolic/diastolic hypertension.

Salix IBS Non-Constipation Study. A Phase 3, 12-week study to assess efficacy and safety of Rifaximin in the treatment of subjects with non-constipation irritable bowel syndrome.

Johnson & Johnson Diabetes Study. A Phase 3, dose ranging study in subjects with type 2 diabetes mellitus evaluating JNJ28431754 and sitagliptin.

Sanofi-Aventis Hypercholesterolemia Study. A 12-month study evaluating 2 doses of AVE5530, co- administered with atorvastatin in patients with primary hypercholesterolemia.

2009

Novartis Systolic Hypertension/Diabetes Study. An 8-week study of Aliskiren HCTZ (300/25 mg) compared to Amlodipine (10 mg) in patients with stage 2 systolic hypertension and diabetes mellitus.

Boehringer Ingelheim Severe Systolic and Diastolic Hypertension Study. A Phase 3, 8-week study comparing Telmisartan plus Amlodipine vs. Telmisartan or Amlodipine alone in patients with severe hypertension.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Roche Diabetes Diabetes Study. A Phase 3, 24-week study, comparing Taspoglutide, Sitagliptin (Januvia), and placebo in patients with type 2 diabetes mellitus inadequately controlled with metformin. There is also a 28-week single blind extension phase where pts on active treatment will continue on same treatment, and pts on placebo will be switched to Taspoglutide.

BioSante Hypoactive Sexual Desire Disorder (HSDD) Study. A Phase 3, placebo controlled, 5- year study (only 9 visits) of the long-term safety and efficacy of LibiGel for treatment of Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.

Daiichi-Sankyo Systolic Hypertension Study. A Phase 4, 20-week, open-label, single arm titration study to evaluate multiple doses of Azor in multiple subgroups of hypertensive subjects who have BP uncontrolled on monotherapy.

Hollis Eden Diabetes Study. A Phase 2, 18-week (12 weeks study drug) trial comparing HE3286 to placebo in patients with drug naïve, type 2 Diabetes Mellitus.

Takeda Systolic Hypertension Study. A Phase 3, 9-week, placebo controlled, systolic HTN trial comparing TAK-491 to Valsartan, Olmesartan, and placebo.

Great Lakes/Novartis Resistant HTN Study. A Phase 2A, 8-week, Resistant HTN study comparing several dose regimens of LC1699 with Eplerenone and placebo.

Daiichi/Sankyo Drug Naïve Diabetes Study. A 28-week, Drug Naïve Type 2 Diabetes trial with Welchol (colesevelam) vs. placebo.

Daiichi/Sankyo Diabetes Pioglitazone Add-on Study. A 28-week, placebo controlled, Type 2 Diabetes trial with Welchol (Colesevelam) as add-on therapy to pioglitazone.

Takeda Diabetes Metformin Add-on Study. A Phase 3, 2-year study comparing Alogliptin to Glipizide when used in combination with Metformin.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Schering-Plough Lipid Study. A Phase 2B, about 22-week study, comparing SCH 900271 to placebo in subjects with Primary Hypercholesterolemia or Mixed Hyperlipidemia.

Daiichi-Sankyo Diastolic Hypertension Study. An 8-week forced titration Olmesartan vs. Losartan in patients with moderate diastolic hypertension.

Shire Diverticulitis Study. A Phase 3, placebo-controlled study evaluating 3 doses of SPD476 over 2 years in the prevention of recurrence of diverticulitis.

GlaxoSmithKline COPD Study. A 52-week study to compare the safety and efficacy of 3 doses of once daily inhaled corticosteroid (ICS)/long-acting beta agonist (LABA) combination vs. LABA alone on the annual rate of COPD exacerbations in subjects with chronic obstructive pulmonary disease (COPD).

Takeda Systolic Hypertension Study. A Phase 3, open label 52-week comparison of TAK- 391/Chlorthalidone vs. Olmesartan/HCTZ in subjects with moderate to severe systolic HTN.

Bristol-Myers Squibb Depression Study. A Depression survey studying patients prescribed a new anti- depressant medication to assess impact of a measurement-based treatment program (MBT) on major depression disorder remission.

Takeda Diabetes Drug-Naïve Study. A Phase 3 study comparing Alogliptin plus Metformin, Alogliptin alone, and Metformin alone.

Abbott Lipid/CKD Study. A 30-week study of the combination ABT-335 plus Rosuvastatin compared to Rosuvastatin monotherapy in dyslipidemic subjects with Stage 3 chronic kidney disease (CKD).

C5Research Coronary Artery Disease Study. An 18-week, phase 2, Dose-Finding and Safety Study of RVX000222 in subjects with stable Coronary Artery Disease and to assess benefits on apoA1 and other lipid parameters.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

2010

Resverlogix CAD Study. A Phase II Multicenter, Double-blind, Randomized, Parallel Group, Placebo-controlled Clinical Trial for Dose-finding and Safety Study of RVX000222 in Subjects with Stable Coronary Artery Disease.

Johnson & Johnson Diabetes Metformin Add-on Study. A Phase 3, 2-year study comparing 2 doses JNJ28431754 with Glimepiride in patients inadequately controlled on Metformin alone.

Novartis HTN/Diabetes Study. An 8-week study comparing Aliskiren in combo with Valsartan versus Valsartan alone in Hypertensive patients with Type 2 Diabetes Mellitus.

Depomed Hot Flash Study. A Phase 3, 24-week, placebo-controlled study to investigate Gabapentin Extended Release in the treatment of vasomotor symptoms in postmenopausal women.

Boehringer Ingelheim COPD Study. A Phase 3B, approximately 3½ year, non-placebo-controlled study to compare 2.5 mcg and 5 mcg Tiotropium solution delivered by the Respimat Inhaler with Tiotropium inhalation capsules 18 mcg delivered by HandiHaler.

Johnson & Johnson Diabetic Peripheral Neuropathy Study. A Randomized Withdrawal, Placebo-Controlled, Study Evaluating the Efficacy, Safety, and Tolerability, of XXX XXX in the Subjects with Chronic, Painful Diabetic Peripheral Neuropathy.

Pozen Gastric Ulcer Study. A Phase 3, 6-month study to evaluate the incidence of gastric ulcers following administration of either PA32540 or enteric coated aspirin 325 mg in subjects with cardiovascular disease at risk for developing aspirin-associated ulcers.

Takeda Gout Study. A Phase 3B study to evaluate cardiovascular safety of febuxostat and Allopurinol in subjects with gout and cardiovascular comorbidities.

Sucampo Opioid-Induced Bowel Dysfunction Study. A Phase 3, 12-week study comparing oral lubipostone to placebo with opioid-induced bowel dysfunction.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

2011

NextBio Flu Study. A Phase 2 trial examining effects of DAS181 in healthy adult subjects with laboratory confirmed influenza.

AstraZeneca Opioid-Induced Constipation Study. A 12-18-week study comparing 2 doses of NKTR- 118 with placebo in the treatment of patients with opioid-induced constipation.

Gilead Angina Study. A Phase 4, cross-over trial evaluating effects of Ranolazine on myocardial perfusion assessed by serial exercise SPECT imaging.

Novartis HTN/Diabetes Study. A 12-week study comparing combination of Valturna and Amlodipine or Valturna and Chlorthalidone versus Valsartan alone in stage 2 Hypertensive patients with Type 2 Diabetes Mellitus.

Abbott Diabetic Nephropathy Study. A Phase 2B, 26-week study evaluating Atrasentan in treating diabetic nephropathy.

BioNovo Hot Flash Study. A Phase 1, open label, 4-week study assessing safety of 2 doses of MF101 for hot flushes and menopausal symptoms in post-menopausal women.

Merck Lipid Study. A Phase 3, 12-week study to evaluate Extended Release Niacin/Laropiprant added to ongoing statin therapy in patients with primary hypercholesterolemia or mixed dyslipidemia.

Metabolox/Pharm-Olam Gout Study. A Phase 2, 12-week study to evaluate MBX-102 in combination with Allopurinol in Gout patients.

Boehringer-Ingelheim Hypertension/Diabetes Study. A Phase 3, 12-week study to evaluate 2 doses of BI 10773 and placebo in hypertensive patients with diabetes mellitus.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Merck Metformin Add-on Diabetes Lipid Study. A Phase 3, 57-week study to evaluate co- administration of sitagliptin and atorvastatin in diabetic patients with inadequate glycemic control on metformin monotherapy.

Purdue Opioid Chronic Low Back Pain Study. A Phase 3, 12-18-week study to assess OXN (oxycodone and naloxone CR) in opioid experienced patients with moderate to severe chronic low back pain.

Forest Moderate-Severe COPD Study. A Phase 3, 24-week study to evaluate fixed dose combination of Aclidinium/Formoterol compared to Aclidinium, Formoterol, and Placebo in Moderate to Severe COPD patients.

2012

Shionogi Opioid-Induced Constipation Study. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of S-297995 for the Treatment of Opioid-Induced Constipation in Subjects with Non-Malignant Chronic Pain Receiving Opioid Therapy.

Salix IBS-D Study. A Phase 3, 30-51-week study assessing repeat treatment of Rifaximin in subjects with irritable bowel syndrome with diarrhea (IBS-D).

Furiex IBS-D Study. A Phase 3, 30-week study to evaluate JNJ-27018966 in the treatment of patients with diarrhea predominant irritable bowel syndrome.

Sanofi Aventis Hypercholesterolemia Study. A 78-week study evaluating REGN727/SAR236553 in high cardiovascular risk patients with hypercholesterolemia not adequately controlled on statin therapy.

Amarin PharmaNet-I3 Hypertriglyceridemia Study. A Phase 3b, long-term study evaluating the effect of AMR101 on cardiovascular health and mortality in hypertriglyceridemic patients with CV disease or at high risk for cardiovascular disease.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Ardea Gout Study. A Phase 3, 12-month study to evaluate Lesinurad and Allopurinol compared to Allopurinol alone in subjects with Gout who have had inadequate hypouricemic response to standard of care Allopurinol.

Merck Cardiovascular/Diabetes Study. A Phase 3, 3-year long-term study in subjects with T2 Diabetes and established CV disease comparing once weekly MK-3102 to placebo.

Akros Diabetes Study. A Phase 2, 22-week study to evaluate the efficacy and safety of JTT- 851 in patients with T2 Diabetes.

Boehringer Ingelheim COPD Study. A Phase 3B, 12-weeks of once daily, orally inhaled, co-administration of olodaterol 5μg (delivered by the Respimat® Inhaler) and tiotropium 18μg (delivered by the HandiHaler®) compared to once daily, orally inhaled tiotropium 18μg (delivered by the HandiHaler®) in patients with Chronic Obstructive Pulmonary Disease (COPD).

Purdue/Quintiles Chronic Low Back Pain/Opioid Induced Constipation Study. A Phase 3, 12-18-week study to assess OXN (oxycodone and naloxone CR) analgesic efficacy and OIC in opioid experienced patients with moderate to severe chronic low back pain (CLBP) and a history of opioid induced constipation.

2013

Roche Icon CV Disease/Glucose Abnormality Study (Long-Term). A Phase 3B Study to evaluate Aleglitazar to reduce cardiovascular risk in patients with stable cardiovascular disease and glucose abnormalities.

Boehringer Ingelheim Diabetes Metformin Add-on Study. A Phase 3B 16-week Study evaluating Empaglifozin twice daily versus once daily in two different doses as add-on therapy to metformin in patients with type 2 diabetes and insufficient glycemic control.

Novartis COPD Study. A Phase 3, 12-week study to assess the efficacy, safety, and tolerability of QVA149 (Indacaterol Maleate/Glycopyrronium bromide) in COPD patients with moderate to severe airflow limitation.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Cubist INC Opioid Induced Constipation Study. A Phase 3, Placebo-Controlled, 12-Month Study to Evaluate the Long-Term Safety and Tolerability of CB-5945 for the Treatment of Opioid- Induced Constipation in Adults Taking Opioid Therapy for Chronic Non-Cancer Pain.

Cubist INC Opioid Induced Constipation Study. A Randomized, Double-Blind, Placebo-Controlled, Phase 3, 12-Week Study to Evaluate the Efficacy and Safety of CIM945 for the Treatment of Opioid-Induced Constipation in Adults Taking Opioid Therapy for Chronic Non-Cancer Pain.

Shionogi Opioid Induced Constipation Study. A Randomized, Double-blind, Placebo-controlled, Parallel-group12-Week Study of Naldemedine in the Treatment of Opioid-induced Constipation in Subjects with Non-malignant Chronic Pain Receiving Opioid Therapy.

Shionogi Opioid Induced Constipation Study. A Randomized Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Study to Evaluate the Long-term Safety of Naldemedine for the Treatment of Opioid-induced Constipation in Subjects with Non- malignant Chronic Pain Receiving Opioid Therapy.

Regeneron Lipid Study. A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Atorvastatin versus Ezetimibe Added-on to Atorvastatin versus Atorvastatin Dose Increase versus Switch to Rosuvastatin in Patients Who are Not Controlled on Atorvastatin.

Regeneron Lipid Study. A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Rosuvastatin versus Ezetimibe Added-on to Rosuvastatin versus Rosuvastatin Dose Increase in Patients Who are Not Controlled on Rosuvastatin.

Merck Diabetes Metformin Add-On Study. A Phase III, 2-Year, Randomized, Double-Blind, Active-Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Ertugliflozin (MK- 8835/PF-04971729) Compared with the Addition of Glimepiride in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Merck Diabetes Metformin/Sitagliptin Add-on Study. A Phase III, 69-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Evaluate the Safety and Efficacy of Ertugliflozin (MK-8835/PF-04971729) in the Treatment of Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin.

Pfizer Lipid Study. A Phase 3 double blind, placebo controlled 4-year study to assess PF- 04950615 in reducing the risk of occurrence of major cardiovascular events in high risk subjects.

Pfizer Lipid Study. A Phase 3, 18-month, double blind, placebo controlled, randomized, stratified, parallel group, clinical trial to compare PF-04950615 150 mg SC Q2wks to placebo for LDL-C lowering in subjects with primary hyperlipidemia or mixed dyslipidemia at high or very high risk for CV events.

SK Life Science Chronic Idiopathic Constipation Study. A 16-Week, Double-Blind, Randomized, Placebo-Controlled, 12-Week, Dose-Range- Finding Trial of 5 and 20mg Capsules of YKP10811 Administered Once Daily at Doses of 5, 10, or 30mg to Subjects with Chronic Idiopathic Constipation.

Forest Ascent COPD Study. A Phase 4, 3-Year, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase IV Study to Evaluate the Effect of Aclidinium Bromide on Long- term Cardiovascular Safety and COPD Exacerbations in Patients with Moderate to Very Severe COPD (ASCENT COPD).

2014

Pfizer Lipid / Cardiovascular Study. A Phase 3 double blind, placebo controlled 4-year study to assess PF-04950615 in reducing the risk of occurrence of major cardiovascular events in high risk subjects.

Esperion Lipid Study. A Phase 2, 12-Week, Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients with or Without Statin Intolerance.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Merck Diabetes Metformin Add-on Study. A Phase III, 69-Week, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Ertugliflozin (MK-8835/PF-04971729) with Sitagliptin Compared with Ertugliflozin Alone and Sitagliptin Alone, in the Treatment of Subjects with T2DM With Inadequate Glycemic Control on Metformin Monotherapy.

Esperion Lipid Study. A Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of ETC-1002 Versus Placebo in Patients with Hypercholesterolemia Receiving Ongoing Statin Therapy.

Menarini IBS-Diarrhea Study. A 12-week double-blind, randomized, placebo-controlled, parallel- group phase III study, followed by a 4-week randomized withdrawal period to evaluate the efficacy and safety of oral Ibodutant 10 mg once daily in female patients with irritable bowel syndrome with diarrhea (IBS-D).

NovoNordisk Diabetes Insulin Study. A randomised, double blind, cross-over trial comparing the safety and efficacy of insulin degludec and insulin glargine, with or without OADs in subjects with type 2 diabetes.

Janssen Diabetes Hypertension Study. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Blood Pressure Reduction with Ambulatory Blood Pressure Monitoring (ABPM), Safety, and Tolerability of Canagliflozin in the Treatment of Subjects with Hypertension and Type 2 Diabetes Mellitus.

Menarini IBS-Diarrhea Study. A 52-week, double-blind, randomised, placebo-controlled, parallel- group phase III study with re-randomisation at week 25 to evaluate the efficacy and safety of oral ibodutant 10 mg once daily in female patients with irritable bowel syndrome with diarrhoea (IBS-D).

Forest LIN MD 40 OIC Study. A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered Orally for 8 Weeks to Adult Outpatients with Opioid-Induced Constipation Receiving Chronic Opioid treatment for Non-Cancer Pain.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Boehringer Ingelheim Diabetes/Hypertension Study. A randomized, double-blind, placebo-controlled, parallel group, efficacy and safety study of empagliflozin (10 mg, 25 mg) administered orally, once daily over 24 weeks in hypertensive black/African American patients with type 2 diabetes mellitus.

Roxane Asthma Study. A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of Generic Fluticasone Propionate 100 μg and Salmeterol Xinafoate 50 μg Inhalation Powder Compared with Advair Diskus® 100/50 in Subjects with Asthma.

2015

Boehringer Ingelheim COPD Study. A randomised, double-blind, active-controlled parallel group study to evaluate the effect of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination compared with tiotropium on Chronic Obstructive Pulmonary Disease (COPD) exacerbation in patients with severe to very severe COPD [DYNAGITO].

Pfizer Lipid Study. A 12-Week Phase 3 study comparing Bococizumab to placebo autoinjector in patients with primary hyperlipidemia or mixed dyslipidemia.

NovoNordisk Diabetes Insulin Study. A 26-week study comparing Insulin degludec/liraglutide vs. basal-bolus therapy in patients with type 2 diabetes mellitus.

Sanofi Diabetes Study. A 52- week randomized, open-label, parallel group real world pragmatic trial to assess the clinical and health outcomes of Toujeo® compared to commercially available basal insulins for initiation of therapy in insulin naïve patients with uncontrolled type 2 diabetes mellitus.

AstraZeneca Diabetes Study. A 4-Week Study Comparing Dapagliflozin versus Placebo on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled with Either Metformin or Insulin.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Proteus Diabetes/Hypertension/Device Study. A 12-Week cluster-randomized, 3-arm study: Use of Proteus Discover to Enable Improved Clinical Outcomes in Subjects with Uncontrolled Hypertension and Type 2 Diabetes Mellitus: A Pilot Study.

GSK COPD Study. A Phase IIIa, 52-week, randomized, double-blind, 3-arm parallel group, global multicenter study evaluating FF/UMEC/VI inhalation powder versus FF/VI inhalation powder and UMEC/VI inhalation powder, all given once daily in the morning.

Theracos Diabetes Study. A long-term 4+ year, double blind placebo-controlled study to evaluate the effects of bexagliflozin on hemoglobin A1c in patients with type 2 diabetes and increased risk of cardiovascular adverse events.

2016

Elcelyx Diabetes Study. A Phase 2, 18-week, randomized, double-blind, parallel-group, multicenter, placebo-controlled, 7-arm, dose-ranging study in subjects with type 2 diabetes mellitus (T2DM).

NovoNordisk Diabetes Study. A 40-week randomised, open-label, active-controlled, parallel group, four-armed trial of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes.

Actelion Hypertension Study. A 12-14 Week double-blind, double-dummy, randomized, placebo- and active-reference, parallel group, Phase 2 dose-finding study with ACT-132577 in subjects with essential hypertension (grade 1 and 2).

Shionogi Vaginal Dryness Study. A Phase 3, 2-YearRandomized, Double-blind, Placebo- controlled Multicenter Study to Evaluate the Efficacy and Safety of Ospemifene in Patients with Moderate to Severe Vaginal Dryness, a Symptom of Vulvo-vaginal Atrophy (VVA) due to Menopause.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Forest LIN 10 Constipation Study. An Open-label, Phase 4, 1-Year Study to Assess the Immunogenicity of Linaclotide Administered Orally to Adult Patients with Irritable Bowel Syndrome with Constipation or Chronic Idiopathic Constipation.

NovoNordisk Diabetes Insulin Study. A 104-week, open-label, two-arm parallel, randomised to insulin degludec/liraglutide (IDegLira) vs. insulin glargine therapy in subjects with T2DM inadequately controlled on OAD(s). vTv Therapeutics Diabetes Metformin Add-on Study. A Phase 2, Randomized, Double-Blind, Placebo- Controlled Parallel-Group Multicenter Study to Evaluate the Efficacy and Safety of TTP273 Following 12 Weeks Administration in Subjects with Type 2 Diabetes Mellitus on a Stable Dose of Metformin.

Ferrer Polypill Hypertension/Lipid Study. A Phase 2B, 12-week study comparing the pharmacodynamics (effect on systolic blood pressure and LDL cholesterol) of the Cardiovascular Fixed Dose Combination Pill AAR (acetylsalicylic acid, atorvastatin and ramipril) to the pharmacodynamics of the corresponding reference products: Altace® (ramipril 10 mg, effect on systolic blood pressure) and Lipitor® (atorvastatin 40 mg, effect on the LDL cholesterol).

Pearl COPD Study. A Phase III randomized, double-blind, parallel group, multicenter, 52- week COPD exacerbation and lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg administered BID.

Vantia Men’s Nocturia/BPH Study. A randomised, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of Fedovapagon in the treatment of nocturia in men with benign prostatic hyperplasia (EQUINOC Study).

Braintree Opioid Induced Constipation Study. A 15-Week, Safety and Efficacy Evaluation of BLI801 Laxative in Adults Experiencing Non-Idiopathic Constipation.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

AstraZeneca COPD Study. A 24-week treatment, evaluating aclidinium bromide 400 μg/formoterol fumarate 12 μg fixed-dose combination BID compared with each monotherapy (aclidinium bromide 400 μg BID and formoterol fumarate 12 μg BID) and tiotropium 18 μg QD when administered to patients with stable chronic obstructive pulmonary disease.

Braeburn Chronic Lower Back Study. A Phase III, 6-month study (Randomized, Double-Blind, Placebo-Controlled, Enriched-Enrollment Withdrawal, Multicenter Study) to Evaluate the Efficacy and Safety of a Long-Acting Subcutaneous Injectable Depot of Buprenorphine (CAM2038) in Subjects with a Recent History of Moderate to Severe Chronic Low Back Pain Currently Treated with Opioids.

Mereo Male Hypogonadism Study. A 36-week, Phase IIb multicentre, double-blind, dose- ranging, randomised, placebo-controlled study evaluating safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism.

Axsome Knee Osteoarthritis Study. A Phase 3, 24-Week, Randomized, Double-blind, Placebo- controlled Trial to Assess the Efficacy and Safety of AXS-02 (Disodium Zoledronate Tetrahydrate) Administered Orally to Subjects with Knee Osteoarthritis Associated with Bone Marrow Lesions.

Bausch & Lomb Post Cataract Study. Sub-Investigator. A Phase 3, Multicenter, Double-Masked, Vehicle-Controlled, Randomized, Parallel-Group Study to Assess Loteprednol Etabonate Ophthalmic Gel, 0.38% (BID and TID) versus Vehicle Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery.

Sanofi Diabetes Metformin Add-on Study. A 79-Week, Randomized, Double-blind, Placebo- controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Added to Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin.

Esperion Statin Intolerant Lipid Study. A Randomized, 29-Week Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180 mg Compared to Placebo Added to Background Lipid-Modifying Therapy in Patients with Elevated LDL-C Who are Statin Intolerant.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Pfizer Knee / Hip Osteoarthritis Study. A Randomized, double-blind, active-controlled, multicenter, parallel-group Phase 3 study of the safety and efficacy of tanezumab when administered by SC injection for 56 weeks compared to NSAIDs in subjects with osteoarthritis of the knee or hip.

2017

Watson Asthma Study. A 6-week, randomized, blinded parallel group, placebo-controlled, multiple dose study to compare the therapeutic equivalence of a budesonide 80 mcg/formoterol fumarate dihydrate 4.5 mcg inhalation aerosol to Symbicort® (budesonide 80 mcg/formoterol fumarate dihydrate 4.5 mcg inhalation aerosol) in adolescent and adult patients with asthma.

AstraZeneca Opioid Induced Constipation (OIC) Study. A Phase IV, Randomized, Multicenter, Open- Label, Prospective, Crossover Study to Evaluate Patient Preference of Movantik™ versus Polyethylene Glycol 3350 (PEG 3350) for Opioid-Induced Constipation (OIC) Treatment.

Theracos Diabetes / CKD Study. A Phase 3, 6-Month, randomized, double-blind, placebo- controlled, parallel-group study to evaluate the efficacy and safety of oral administration of Bexagliflozin tablets, 20 mg compared to placebo in subjects with type 2 diabetes mellitus (T2DM), moderate renal impairment, and inadequate glycemic control.

NovoNordisk SGLT-2 Inhibitor Add-on Diabetes Study. A 30-Week, Randomized, double blind, placebo-controlled study, Efficacy and safety of Semaglutide once-weekly versus placebo as add-on to SGLT-2i in subjects with type 2 diabetes mellitus.

Esperion Lipid Study. A Phase 2, 5-Month, Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180 mg QD when added to PCSK9-Inhibitor Therapy.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

NovoNordisk Diabetes Insulin Study. A 52-week, randomised (1:1), open-label, parallel, multicentre, multi-national, treat-to-142 target (TTT), active-controlled trial comparing the efficacy and safety of IDeg with IGlar U300, 143 both administered once daily ± OADs in subjects with T2DM previously treated with basal insulin 144 once or twice daily ± OADs excluding sulfonylureas (SUs)/glinides.

AstraZeneca Digital Disease Management Tool / Diabetes. A real-world, point-of-care, randomized, parallel group, open, 6-month clinical study to evaluate the effect of a digital disease management tool in patients with type 2 diabetes mellitus.

NovoNordisk SGLT-2 Inhibitor Add-on Diabetes Study. A 29-week, 2:1 randomized, placebo controlled, double blind trial investigating the effect and safety of liraglutide versus placebo as add-on to an SGLT2 inhibitor with or without metformin in subjects with type 2 diabetes mellitus who have not achieved adequate glycemic control despite stable treatment with SGLT2 inhibitor ± metformin.

AstraZeneca Uric Acid/CKD Study. A 6-Month Study, Effects of Intensive Uric Acid Lowering Therapy with RDEA3170 and Febuxostat in Patients with Chronic Kidney Disease.

AstraZeneca COPD Study. A 6-Month, Study Comparing Bevespi Aerosphere® (glycopyrronium/ formoterol fixed-dose combination) to Anoro® Ellipta® (umeclidinium/vilanterol fixed- dose combination) in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (VERSUS).

Shire Conjunctivitis Study. A Phase 3, 12-Day, Multicenter, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1 %) Ophthalmic Suspension Compared to PVP-Iodine and Placebo in the Treatment of Adenoviral Conjunctivitis.

Shire Conjunctivitis Study. A Phase 3, Multicenter, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in the Treatment of Bacterial Conjunctivitis.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Theracos Diabetes Metformin Add-on Study. A 24-Week, Phase 3, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Effects of Bexagliflozin versus Sitagliptin in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control by Metformin.

Theracos Hypertension Study. A 36-Week, Double Blind Placebo Controlled Study to Evaluate the Efficacy and Safety of Bexagliflozin in Patients with Essential Hypertension.

Chiesi COPD Study. A 6-week, randomized, double-blind, placebo and active-controlled, parallel group, dose ranging study to evaluate the efficacy and safety of 4 doses of CHF 5259 pMDI (Glycopyrronium Bromide) in subjects with Chronic Obstructive Pulmonary Disease (COPD).

Chiesi Asthma Study. An 8-week, randomized, double-blind, placebo and active-controlled, parallel group, dose ranging study to evaluate the efficacy and safety of 3 doses of CHF 718 pMDI (Beclomethasone Dipropionate) in asthmatic subjects.

GSK COPD Study. A 24-week treatment, multicenter, randomized, double-blind, double- dummy, parallel group study to compare Umeclidinium/Vilanterol, Umeclidinium, and Salmeterol in subjects with chronic obstructive pulmonary disease (COPD)).

Pfizer NALD/NASH Study. A Phase 2A, randomized, double blind, placebo-controlled to evaluate PF-05221304 administered for 16 weeks to subjects with non-alcoholic fatty liver disease.

NovoNordisk Basal/Bolus Insulin Diabetes Study. A Phase 3b, 28-week, 1:1 randomised, double- blind, active controlled, treat-to-target, parallel group trial (including 12-week run-in period) comparing faster Aspart to NovoRapid® both in combination with insulin Degludec with or without metformin in subjects with T2DM treated with a basal-bolus regimen.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Sanofi Diabetes Metformin Add-on Study. A 52-Week Randomized, Double-blind, Placebo- controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Added to Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin.

Sanofi DM/CV/CKD Study. A 4+ year, Randomized, Double-blind, Placebo-controlled, Parallel- group, Multicenter Study to Demonstrate the Effects of Sotagliflozin on Cardiovascular and Renal Events in Patients with Type 2 Diabetes, Cardiovascular Risk Factors and Moderately Impaired Renal Function. The SCORED trial.

Esperion Lipid/Cardiovascular Study. A 14-Week Study Comparing Bempedoic Acid 180 mg + Ezetimibe 10 mg Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo Alone in Patients Treated with Maximally Tolerated Statin Therapy.

MedImmune Lipid/Cardiovascular Study. A 4-Month, Phase 2a Randomized, Double-blind, Placebo- controlled, Parallel-designed Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Subjects with Stable Coronary Heart Disease.

Medicines (ORION-10) Lipid/Cardiovascular Study. A 16-month placebo-controlled, double-blind, randomized trial to evaluate the effect of 300 mg of Inclisiran sodium given as subcutaneous injections in subjects with atherosclerotic cardiovascular disease (ASCVD) and elevated low-density lipoprotein cholesterol (LDL-C).

2018

Ogeda Hot Flash Study. A Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging, Phase 2b Study to Investigate the Efficacy of ESN364 in Postmenopausal Women Suffering from Vasomotor Symptoms (Hot Flashes).

Transition BPH Study. A Randomized, Double-blind, Placebo-controlled Dose-ranging Study of OPK-88004 Once-a-day Dosing for 16 Weeks in Men with Signs and Symptoms of Benign Prostatic Hyperplasia.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Ferring Prostate Cancer Study. A 2-Month Study Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients with Prostate Cancer and Cardiovascular Disease Receiving Degarelix (GnRH Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist).

Esperion Diabetes and Lipid Study. A randomized study, double blind, placebo controlled study to evaluate the safety and effectiveness of Bempedoic Acid (180 mg pill) + Ezetimibe (10 mg pill) when compared to Ezetimibe and Plaebo in Subjects with Type 2 Diabetes and Elevated LDL Cholesterol.

Esperion Statin Intolerance Study. A Randomized, Double-Blind, Placebo-Controlled Study To Assess The Effects Of Bempedoic Acid (Etc-1002) On The Occurrence Of Major Cardiovascular Events In Patients With, Or At High Risk For, Cardiovascular Disease Who Are Statin Intolerant.

Ritter Lactose Intolerance Study. A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Durability, Safety, and Tolerability of RPG28 in Patients with Lactose Intolerance.

Sanofi Diabetes and Cardiovascular Study. A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Efpeglenatide on Cardiovascular Outcomes in Type 2 Diabetes Patients at High Cardiovascular Risk.

Sanofi Diabetes, Chronic Kidney Disease, and Cardiovascular Study. A 4+ year, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Effects of Sotagliflozin on Cardiovascular and Renal Events in Patients with Type 2 Diabetes, Cardiovascular Risk Factors and Moderately Impaired Renal Function. The SCORED trial.

Enanta NASH (Fatty Liver) Study. A Phase 2, 20-Week, Dose Ranging, Randomized, Double Blind, and Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Non-Alcoholic Steatohepatitis (NASH).

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Idorsia Resistant Hypertension Study. A 64-Week, multi-center, double-blind, randomized, parallel-group, Phase 3 study with aprocitentan in subjects with Resistant Hypertension.

Ferring Nocturia Study. A Randomized, Double-blind, Placebo-controlled, Response-adaptive, Dose-finding Trial Investigating the Efficacy, Safety and Tolerability of Oral Doses of FE 201836, with Desmopressin Orally Disintegrating Tablet as a Benchmark, During 12 Weeks of Treatment for Nocturia due to Nocturnal Polyuria in Adults.

Westward Pharm Olam Asthma Study. A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of Generic Fluticasone Propionate 100 μg and Salmeterol Xinafoate 50 μg Inhalation Powder Compared with Advair Diskus® 100/50 in Subjects with Asthma.

Idorsia Insomnia Study. A 3-month, multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to assess the efficacy and safety of two doses (10 mg and 25 mg) of ACT-541468 in subjects with insomnia disorder.

Teva Novum Asthma Study. A Randomized, Multiple-Dose, Blinded, Placebo-Controlled, Parallel- Design, Multiple-Center, Clinical Study to Evaluate the Therapeutic Equivalence of Fluticasone Propionate and Salmeterol Inhalation Powder, 100 mcg/50 mcg to ADVAIR DISKUS® 100/50.

Velicept Therapeutics Overactive Bladder Study. A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Oral Solabegron Modified Release Tablets in the Treatment of Overactive Bladder (OAB) in Adult Female Subjects.

GSK COPD Study. A randomized study, comparing FF/UMEC/VI single inhaler triple therapy versus tiotropium monotherapy in participants with chronic obstructive pulmonary disease.

Mitsubishi Hot Flash Study. A Phase 2 randomized study, double blind, placebo controlled study to assess the effect of MT-8554 on the frequency and severity of vasomotor symptoms in postmenopausal women.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Sanofi Diabetes Basil Insulin Study. A Randomized, Double-blind, Placebo-controlled, Parallel- group, 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Alone or in Addition to Oral Antidiabetes Drugs (OADs).

2019

Allergan Ulcerative Colitis Study. A 52-Week, Multicenter, Randomized, Double-blind, Double- dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel- group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease.

Allergan Crohn’s Disease (CD) Study. A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease.

Teva CompleWare Asthma Study. A Randomized, Blinded, Parallel Group, Placebo-Controlled, Multiple Dose, Multicenter Study to Compare the Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg, in Adults with Asthma.

Amneal Pharmaceuticals Asthma Study. A Randomized, Blinded, Multiple-Dose, Placebo-Controlled, Multi- Center Study Comparing Beclomethasone Dipropionate HFA Inhalation Aerosol, 40 mcg to QVAR® 40 mcg (beclomethasone dipropionate HFA), Inhalation Aerosol in Treatment of Subjects with Asthma.

Axsome Therapeutics Treatment-Resistant Depression Study. A Randomized, Blinded, Multiple-Dose, Placebo-Controlled, Multi-Center Study Comparing Beclomethasone Dipropionate HFA Inhalation Aerosol, 40 mcg to QVAR® 40 mcg (beclomethasone dipropionate HFA), Inhalation Aerosol in Treatment of Subjects with Asthma.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

NovoNordisk Diabetic Retinopathy Study. A Randomized, double-masked, parallel-group, placebo- controlled (1:1) trial comparing the effects of semaglutide (non-insulin) vs placebo on diabetic retinopathy progression each administered by injection once-weekly, and both added to standard-of-care in subjects with inadequately controlled T2D.

NovoNordisk Diabetes CKD Study. FLOW - Effect of semaglutide versus placebo on the progression of renal impairment in subjects with type 2 diabetes and chronic kidney disease.

Abbvie Low Testosterone / Cardiovascular Disease Study. Phase 4, 5-year study of topical testosterone replacement therapy (TRT) in symptomatic hypogonadal men with increased risk for cardiovascular (CV) disease.

Mitsubishi Hot Flash Extension Study. An open-label, long-term extension study of MT-8554 in postmenopausal women experiencing moderate to severe vasomotor symptoms who completed Study MT-8554-A01.

Astellas Hot Flash Study 302. 52-Week, Phase 3, Randomized, Placebo-controlled, 12-week Double-blind Study, followed by a Single-arm Open-label Treatment Period, to Assess the Efficacy and Safety of Fezolinetant in Women Suffering from Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated with Menopause (Skylight 2).

Astellas Hot Flash Study 304. 52-Week, Randomized, Placebo-Controlled, Double-Blind Phase 3 Clinical Study to Investigate the Long-Term Safety of Fezolinetant in Women Suffering From Vasomotor Symptoms (Hot Flashes) Associated with Menopause.

Pfizer NASH DM Metformin Study. Phase 2a, 3-arm, 16-week, double-blind safety and pharmacodynamic study in adults with non-alcoholic fatty liver disease and type 2 diabetes mellitus.

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Medicines (ORION-08) Lipid/Cardiovascular Study. A long term extension trial of the Phase III lipid-lowering trials to assess the effect of long term dosing of inclisiran given as subcutaneous injections in subjects with high cardiovascular risk and elevated LDL-C (ORION-8).

Applied Therapeutics Diabetic Cardiomyopathy Study. Aldose Reductase Inhibition for Stabilization of Exercise capacity in Heart Failure (ARISE-HF): A Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-001 in Patients with Diabetic Cardiomyopathy / Stage B Heart Failure at High Risk of Progression to Overt Heart Failure (Stage C Heart Failure.

Mithra Estetra Hot Flash Study. A Randomized Double-blind Placebo Controlled Phase 3 Trial to evaluate the Efficacy and Safety of Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study II).

Astra Zeneca MedImmune NASH Study. A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacodynamic Effects of MEDI0382 in Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)/ Non-alcoholic Steatohepatitis (NASH).

ProSciento NASH PASS™: A population-based epidemiological NAFLD/NASH registry and research project.

Jiangsu Hengrui Medicine Type 1 Diabetes Mellitus Study. A Phase I, Randomized, Single-Center, Double-Blind, Cross-Over Trial to Assess the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of INS068 as Compared to Insulin Degludec in Subjects With Type 1 Diabetes Mellitus at Steady State.

3-V Biosciences NASH Study. A Phase 2, Multi-Center, Single-Blind, Randomized, Placebo-Controlled Study of TVB- 2640 in Subjects With Non-Alcoholic Steatohepatitis

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Jeffrey D. Wayne, MD Clinical Trials Research, Inc PRINCIPAL INVESTIGATOR

Boston Pharmaceuticals IBS-D Study. A Phase 2a, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BOS-589 in the Treatment of Patients with Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)

Astra Zeneca MedImmune Diabetic Kidney Disease Study. A Phase 2a Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects with Diabetic Kidney Disease

2020

Lipocine NASH/Male Hypogonadism Study Phase 2, Randomized Double-Blind, Placebo- Controlled, Multi-Center Study to Assess the Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects with Nonalcoholic Steatohepatitis (NASH)

______03Mar2020______Signature Date Updated 21Jan2020

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