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Study Protocol Cover Page for Protocol Sponsor name: Novo Nordisk A/S NCT number NCT02453711 Sponsor trial ID: NN9536-4153 Official title of study: Investigation of safety and efficacy of once-daily semaglutide in obese subjects without diabetes mellitus Document date: 24 October 2017 6HPDJOXWLGH 'DWH 2FWREHU 1RYR1RUGLVN 7ULDO,'11 CONFIDENTIAL&21),'(17,$/ 9HUVLRQ &OLQLFDO7ULDO5HSRUW 6WDWXV )LQDO $SSHQGL[ 3URWRFRODQGSURWRFRODPHQGPHQWV /LVWRIFRQWHQWV 3URWRFRO /LQN $SSHQGL[$ 0RQLWRULQJRIFDOFLWRQLQ /LQN $SSHQGL[% ,:4R//LWHIRU&OLQLFDO7ULDOV /LQN $SSHQGL[& 3DWLHQWV¶JOREDOLPSUHVVLRQRIFKDQJH /LQN $SSHQGL[' 1DXVHDTXHVWLRQQDLUH /LQN $SSHQGL[( 0(6,DQG$(VZLWKDGGLWLRQDOGDWDFROOHFWLRQ /LQN $WWDFKPHQW,DQG,, /LVWRINH\ VWDII /LQN 3URWRFRODPHQGPHQW %( /LQN 3URWRFRODPHQGPHQW *OREDO /LQN 3URWRFRODPHQGPHQW *OREDO /LQN Redacted protocol Includes redaction of personal identifiable information only. Protocol Date: 17 April 2015 1RYR1RUGLVN Trial ID: NN9536-4153 Version: 1.0 CONFIDENTIAL UTN: U1111-1155-4660 Status: Final EudraCT no.: 2014-001540-38 Page: 1 of 100 Protocol Trial ID: NN9536-4153 Investigation of safety and efficacy of once-daily semaglutide in obese subjects without diabetes mellitus A 52-week, randomised, double-blind, placebo-controlled, nine-armed, parallel group, multi-centre, multinational trial with liraglutide 3.0 mg as active comparator Trial phase: 2 Protocol originator This confidential document is the property of Novo Nordisk. No unpublished information contained herein may be This confidential document is the property of Novo Nordisk. No unpublished information contained herein may be disclosed without prior written approval from Novo Nordisk. Access to this document must be restricted to relevant disclosed without prior written approval from Novo Nordisk. Access to this document must be restricted to relevant parties. parties. Protocol Date: 17 April 2015 1RYR1RUGLVN Trial ID: NN9536-4153 Version: 1.0 CONFIDENTIAL UTN: U1111-1155-4660 Status: Final EudraCT no.: 2014-001540-38 Page: 2 of 100 Table of Contents Page Table of Contents..............................................................................................................................................2 Table of Figures................................................................................................................................................6 Table of Tables..................................................................................................................................................6 List of abbreviations.........................................................................................................................................7 1 Summary....................................................................................................................................................9 2 Flow chart ................................................................................................................................................12 3 Background information and rationale for the trial............................................................................15 3.1 Background information..............................................................................................................15 3.1.1 Glucagon-like peptide-1 ............................................................................................15 3.1.2 Semaglutide ...............................................................................................................15 3.1.3 Liraglutide..................................................................................................................16 3.1.4 Nonclinical data .........................................................................................................16 3.1.5 Clinical data ...............................................................................................................17 3.2 Rationale for the trial ...................................................................................................................19 4 Objectives and endpoints........................................................................................................................20 4.1 Objectives ....................................................................................................................................20 4.2 Endpoints .....................................................................................................................................20 4.2.1 Primary endpoint........................................................................................................20 4.2.2 Secondary endpoints..................................................................................................20 5 Trial design ..............................................................................................................................................23 5.1 Type of trial .................................................................................................................................23 5.2 Rationale for trial design..............................................................................................................24 5.3 Treatment of subjects...................................................................................................................25 5.3.1 Semaglutide treatment ...............................................................................................25 5.3.2 Liraglutide treatment..................................................................................................26 5.3.3 Missed dose................................................................................................................26 5.3.4 Nutritional and physical activity counselling ............................................................26 5.4 Treatment after discontinuation of trial product ..........................................................................26 5.5 Rationale for treatment ................................................................................................................27 6 Trial population.......................................................................................................................................28 6.1 Number of subjects ......................................................................................................................28 6.2 Inclusion criteria ..........................................................................................................................28 6.3 Exclusion criteria .........................................................................................................................28 6.4 Discontinuation of trial product criteria and withdrawal of informed consent............................29 6.5 Rationale for trial population.......................................................................................................30 7 Milestones.................................................................................................................................................32 8 Methods and assessments .......................................................................................................................33 8.1 Visit procedures ...........................................................................................................................33 8.1.1 Screening, re-screening and screening failures..........................................................33 Protocol Date: 17 April 2015 1RYR1RUGLVN Trial ID: NN9536-4153 Version: 1.0 CONFIDENTIAL UTN: U1111-1155-4660 Status: Final EudraCT no.: 2014-001540-38 Page: 3 of 100 8.1.2 Fasting visits ..............................................................................................................33 8.1.3 Missed visits ..............................................................................................................34 8.1.4 Discontinuation of trial product.................................................................................34 8.1.5 Withdrawn subjects....................................................................................................34 8.1.6 Subject training..........................................................................................................34 8.1.7 Investigator’s assessment...........................................................................................35 8.2 Subject related information..........................................................................................................35 8.2.1 Demography...............................................................................................................35 8.2.2 Concomitant illness and medical history ...................................................................36 8.2.2.1 History of concomitant cardiovascular disease...................................36 8.2.2.2 History of gallbladder disease.............................................................36 8.2.2.3 History of psychiatric disorders ..........................................................36 8.2.2.4 History of breast neoplasms ................................................................36 8.2.2.5 History of colon neoplasms.................................................................37 8.2.3 Concomitant medication............................................................................................37 8.2.3.1 Evaluation of antihypertensive and lipid-lowering treatment .............37
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