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Clinical Research Protocol CLINICAL RESEARCH PROTOCOL NCT02399475 The Thyroid Axis in Older Individuals with Persistent Subclinical Hypothyroidism: a Mechanistic, Randomized, Double-Blind, Cross-Over Study of Levothyroxine and Liothyronine Administration Regulatory Sponsor: Anne R. Cappola, MD, ScM Division of Endocrinology, Diabetes, and Metabolism 12-136 Translational Research Center 3400 Civic Center Blvd, Bldg 421 Philadelphia, PA 19104-5160 (215) 573 5359 Funding Sponsor: National Institute on Aging, NIH Medications Used: Thyrotropin Releasing Hormone (TRH) Levothyroxine (LT4) Liothyronine (LT3) Protocol Number: 821564 IND Number: 125167 Initial version:[11/26/2014] Amended [7/22/2015] Amended: [12/18/2014] Amended [9/9/2015] Amended: [1/2/2015] Amended [8/25/2016] Amended: [3/26/2015] Amended [12/23/2016] Amended: [5/13/2015] Amended [3/24/2017] Amended: [06/04/2015] Amended [9/26/2017] Amended: [6/10/2015] Amended [12/18/2017] (additional next page) Amended [12/18/18] CONFIDENTIAL This material is the property of the University of Pennsylvania. Do not disclose or use except as authorized in writing by the study sponsor LT4 and LT3 in Subclinical Hypothyroidism Page ii Version 12/18/2018 Table of Contents STUDY SUMMARY ......................................................................................................... 1 1 INTRODUCTION ...................................................................................................... 3 1.1 BACKGROUND ..................................................................................................... 3 1.2 INTERVENTIONAL AGENTS .................................................................................... 4 1.3 PRECLINICAL DATA .............................................................................................. 4 1.4 CLINICAL DATA TO DATE ...................................................................................... 5 1.5 DOSE RATIONALE AND RISK/BENEFITS .................................................................. 6 2 STUDY OBJECTIVES ............................................................................................. 8 3 STUDY DESIGN ...................................................................................................... 9 3.1 GENERAL DESIGN ................................................................................................ 9 3.2 PRIMARY STUDY ENDPOINTS .............................................................................. 10 3.3 SECONDARY STUDY ENDPOINTS ......................................................................... 10 3.4 PRIMARY SAFETY ENDPOINTS ............................................................................ 10 4 SUBJECT SELECTION AND WITHDRAWAL ...................................................... 11 4.1 INCLUSION CRITERIA .......................................................................................... 11 4.2 EXCLUSION CRITERIA ........................................................................................ 11 4.3 SUBJECT RECRUITMENT AND SCREENING ............................................................ 12 4.4 EARLY WITHDRAWAL OF SUBJECTS .................................................................... 12 4.4.1 When and How to Withdraw Subjects ...................................................... 12 4.4.2 Data Collection and Follow-up for Withdrawn Subjects ........................... 12 5 STUDY DRUGS ..................................................................................................... 13 5.1 DESCRIPTION .................................................................................................... 13 5.2 TREATMENT REGIMEN ........................................................................................ 13 5.3 METHOD FOR ASSIGNING SUBJECTS TO TREATMENT GROUPS .............................. 15 5.4 PREPARATION AND ADMINISTRATION OF STUDY DRUG .......................................... 15 5.5 SUBJECT COMPLIANCE MONITORING ................................................................... 16 5.6 PRIOR AND CONCOMITANT THERAPY ................................................................... 16 5.7 PACKAGING ...................................................................................................... 16 5.8 BLINDING OF STUDY DRUG ................................................................................. 16 5.9 RECEIVING, STORAGE, DISPENSING AND RETURN ................................................ 17 5.9.1 Receipt of Drug Supplies ......................................................................... 17 5.9.2 Storage .................................................................................................... 17 5.9.3 Dispensing of Study Drug ........................................................................ 17 5.9.4 Return or Destruction of Study Drug ........................................................ 17 6 STUDY PROCEDURES ......................................................................................... 17 6.1 SCREENING VISIT (DAY -60 TO DAY -1) ............................................................... 17 6.2 VISIT 1 (DAY 1) ................................................................................................. 18 6.3 DAY 2-WEEK 4 .................................................................................................. 19 6.4 MEDICATION TITRATION (Q4WEEKS) .................................................................. 19 6.5 VISIT 2 ............................................................................................................. 19 CONFIDENTIAL This material is the property of the University of Pennsylvania. Do not disclose or use except as authorized in writing by the study sponsor LT4 and LT3 in Subclinical Hypothyroidism Page iii Version 12/18/2018 6.6 VISIT 3 ............................................................................................................. 20 6.7 PHONE CONTACTS ............................................................................................ 20 6.8 ASSAYS ............................................................................................................ 20 7 STATISTICAL PLAN ............................................................................................. 21 7.1 SAMPLE SIZE DETERMINATION ............................................................................ 21 7.2 STATISTICAL METHODS ...................................................................................... 21 7.3 SUBJECT POPULATION(S) FOR ANALYSIS ............................................................. 21 8 SAFETY AND ADVERSE EVENTS ....................................................................... 21 8.1 DEFINITIONS ..................................................................................................... 21 8.2 RECORDING OF ADVERSE EVENTS ...................................................................... 24 8.3 REPORTING OF SERIOUS ADVERSE EVENTS AND UNANTICIPATED PROBLEMS ........ 24 8.3.1 Investigator reporting: notifying the study sponsor ................................... 24 8.3.2 Investigator reporting: notifying the Penn IRB .......................................... 25 8.3.3 Sponsor reporting: Notifying the FDA ...................................................... 26 8.4 UNBLINDING PROCEDURES ................................................................................. 27 8.5 STOPPING RULES .............................................................................................. 27 8.6 MEDICAL MONITORING ....................................................................................... 28 9 DATA HANDLING AND RECORD KEEPING ....................................................... 28 9.1 CONFIDENTIALITY .............................................................................................. 28 9.2 SOURCE DOCUMENTS ........................................................................................ 28 9.3 CASE REPORT FORMS ....................................................................................... 28 10 STUDY MONITORING, AUDITING, AND INSPECTING ................................... 29 10.1 STUDY MONITORING PLAN ................................................................................. 29 10.2 AUDITING AND INSPECTING ................................................................................. 30 11 ETHICAL CONSIDERATIONS ........................................................................... 30 12 STUDY FINANCES ............................................................................................ 31 12.1 FUNDING SOURCE ............................................................................................. 31 12.2 CONFLICT OF INTEREST ..................................................................................... 31 12.3 SUBJECT STIPENDS OR PAYMENTS ..................................................................... 31 13 PUBLICATION PLAN ........................................................................................ 31 14 REFERENCES ................................................................................................... 31 15 ATTACHMENTS ................................................................................................ 33 16 APPENDIX ......................................................................................................... 33 16.1 APPENDIX 1 ...................................................................................................... 33 16.2 APPENDIX
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