AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight (AMAZE 1)
Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Obesity (AMAZE 1)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 3
Contacts and Locations
Study Contact
Study Contact
- Name: Novo Nordisk
- Phone Number: (+1) 866-867-7178
- Email: clinicaltrials@novonordisk.com
Study Locations
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Buenos Aires, Argentina, C1425AGC
- Recruiting
- Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
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Córdoba, Argentina, 5000
- Recruiting
- Instituto de Investigaciones Clínicas Córdoba
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Esperanza, Santa Fe, Argentina, S3080BQV
- Recruiting
- Sanatorio Esperanza
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Godoy Cruz, Argentina, M5501ARP
- Recruiting
- CIPADI
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San Nicolás, Argentina, B2900
- Recruiting
- Instituto de Investigaciones Clinicas San Nicolás
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La Pampa Province
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Santa Rosa, La Pampa Province, Argentina, 6300
- Recruiting
- Fundación CESIM
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New South Wales
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Campbelltown, New South Wales, Australia, 2560
- Recruiting
- Sydney Clinical Trials
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Liverpool, New South Wales, Australia, 2170
- Recruiting
- Sydney Cardiometabolic Centre
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Merewether, New South Wales, Australia, 2291
- Recruiting
- Hunter Diabetes Centre
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Queensland
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Chelmer, Queensland, Australia, 4068
- Recruiting
- Heart of Australia
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Brussels, Belgium, 1070
- Recruiting
- HUB - Hôpital Erasme
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Edegem, Belgium, 2650
- Recruiting
- UZA - UZ Antwerpen - Department of Endocrinology
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Ghent, Belgium, 9000
- Recruiting
- Universitair Ziekenhuis Gent
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Leuven, Belgium, 3000
- Recruiting
- UZ Leuven - Endocrinology
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Mechelen, Belgium, 2800
- Recruiting
- Meclinas
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Roeselare, Belgium, 8800
- Recruiting
- AZ Delta - Roeselare
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Alberta
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Calgary, Alberta, Canada, T2V 4J2
- Recruiting
- C-Health Partners
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British Columbia
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Surrey, British Columbia, Canada, V3Z 2N6
- Recruiting
- Ocean West Research Clinic
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New Brunswick
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Moncton, New Brunswick, Canada, E1G 1A7
- Recruiting
- G.A. Research Associates Ltd.
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H1V7
- Recruiting
- Nova Scotia Hlth Halifax
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Ontario
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London, Ontario, Canada, N5W 6A2
- Recruiting
- Milestone Research
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Gandrup, Denmark, 9362
- Recruiting
- Sanos Clinic - Gandrup
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Gistrup, Denmark, 9260
- Completed
- Steno Diabetes Center Nordjylland
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Hellerup, Denmark, 2900
- Recruiting
- Gentofte Hospital - Center for Klinisk Metabolisk Forskning
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Hillerød, Denmark, 3400
- Recruiting
- Hillerød Endokrinologisk amb. H0652
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Hvidovre, Denmark, 2650
- Recruiting
- Hvidovre Hospital Endokrinologisk forsknings afsnit 159
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Region Syddanmark
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Vejle, Region Syddanmark, Denmark, 7100
- Recruiting
- Sanos Clinic - Vejle
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Paris, France, 75015
- Recruiting
- HOPITAL EUROPEEN GEORGES POMPIDOU_Service de nutrition et diabétologie
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Pierre-Bénite, France, 69310
- Recruiting
- HCL-HOPITAL LYON SUD_Service d'Endocrinologie-Diabète-Nutrition
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Saint-Herblain, France, 44800
- Recruiting
- CHU NANTES - HOPITAL NORD LAENNEC_Service d'Endocrinologie-Diabétologie-Nutrition
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Toulouse, France, 31059
- Recruiting
- CENTRE HOSPITALIER UNIVERSITAIRE DE TOULOUSE-HOPITAL RANGUEIL-Service de diabétologie et nutrition
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Vénissieux, France, 69200
- Recruiting
- CENTRE DE RECHERCHE CLINIQUE PORTES DU SUD_Service d'Endocrinologie-Diabétologie-Maladies Métaboliques
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Bad Oeynhausen, Germany, 32545
- Recruiting
- Herz- und Diabeteszentrum NRW - Bad Oeynhausen
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Elsterwerda, Germany, 04910
- Recruiting
- Zentrum für klinische Studien Südbrandenburg GmbH
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Fulda, Germany, 36037
- Recruiting
- MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien
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Magdeburg, Germany, 39120
- Recruiting
- SMO.MD GmbH - Zentrum für klinische Studien
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Osnabrück, Germany, 49080
- Recruiting
- Institut für Diabetesforschung Osnabrück
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Witten, Germany, 58455
- Recruiting
- Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann
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Bradford-on-Avon, United Kingdom, BA15 1DQ
- Recruiting
- The Health Centre
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Cheshire, United Kingdom, CH65 4LE
- Recruiting
- EMS Healthcare
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Hounslow, United Kingdom, TW4 7NJ
- Recruiting
- HMC Health - Heston - The Meadows Centre for Health
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Nantwich, United Kingdom, CW5 5NX
- Recruiting
- Kiltearn Medical Centre
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Plymouth, United Kingdom, PL5 3JB
- Recruiting
- Knowle House Surgery
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Rotherham, United Kingdom, S65 1DA
- Recruiting
- Clifton Medical Centre
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Soham, United Kingdom, CB7 5JD
- Recruiting
- Staploe Medical Centre
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Wellingborough, United Kingdom, NN8 4RW
- Recruiting
- Albany House Medical Centre
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Cornwall
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Fowey, Cornwall, United Kingdom, PL23 1DT
- Recruiting
- Fowey River Practice
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Dorset
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Poole, Dorset, United Kingdom, BH16 5PW
- Recruiting
- The Adam Practice
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North Yorkshire
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Pickering, North Yorkshire, United Kingdom, YO18 8BL
- Recruiting
- Pickering Medical Practice
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Surrey
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Addlestone, Surrey, United Kingdom, KT15 2BH
- Recruiting
- The Crouch Oak Family Practice
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Florida
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Miramar, Florida, United States, 33027
- Recruiting
- South Broward Research LLC
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Orlando, Florida, United States, 32801
- Recruiting
- Clinical Neuroscience Solution
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Georgia
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Conyers, Georgia, United States, 30094
- Recruiting
- Hope Clin Res & Wellness
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Illinois
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Skokie, Illinois, United States, 60077
- Recruiting
- Endeavor Health
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Indiana
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Indianapolis, Indiana, United States, 46260
- Recruiting
- Midwest Inst For Clin Res
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Missouri
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City of Saint Peters, Missouri, United States, 63303
- Recruiting
- StudyMetrix Research LLC
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New York
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New York, New York, United States, 10075
- Recruiting
- New York Gastroenterology Associates
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- Recruiting
- UNC Eastowne Medical Office
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Greensboro, North Carolina, United States, 27408
- Recruiting
- PharmQuest Life Sciences LLC
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Wilmington, North Carolina, United States, 28401
- Recruiting
- Accellacare and KDCILM, LLC
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- UPA Ctr Weight and Eating Dis
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Rhode Island
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Cumberland, Rhode Island, United States, 02864
- Recruiting
- Clinical Res Collaborative
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South Carolina
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Charleston, South Carolina, United States, 29425
- Recruiting
- Medical Uni of SC Charleston
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North Charleston, South Carolina, United States, 29405
- Recruiting
- Coastal Carolina Research Ctr
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Simpsonville, South Carolina, United States, 29681-1538
- Recruiting
- Hillcrest Clinical Research
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Texas
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Amarillo, Texas, United States, 79124
- Recruiting
- Amarillo Medical Specialists
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Dallas, Texas, United States, 75230-6855
- Recruiting
- Velocity Clinical Res-Dallas
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Forney, Texas, United States, 75126
- Recruiting
- Care United Research, LLC
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Virginia
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Arlington, Virginia, United States, 22206
- Recruiting
- Washington Cntr Weight Mgmt
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Newport News, Virginia, United States, 23606
- Recruiting
- Health Res of Hampton Roads
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Winchester, Virginia, United States, 22601-3834
- Recruiting
- Selma Medical Associates
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Washington
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Renton, Washington, United States, 98057
- Recruiting
- Rainier Clin Res Ctr Inc
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Key Inclusion Criteria:
- Male or female (sex at birth).
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
Key Exclusion Criteria:
- HbA1c ≥ 6.5% (48 millimole per mole [mmol/mol]) as measured by the central laboratory at screening.
- History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records.
- Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues before screening.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: NNC0487-0111
Participants will be randomized to receive 1 out of 4 different dose levels subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
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NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
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Placebo Comparator: Placebo
Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
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Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Relative change in body weight
Time Frame: From baseline (week 0) to week 84
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Measured as percentage of body weight.
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From baseline (week 0) to week 84
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in waist circumference
Time Frame: From baseline (week 0) to week 84 and week 136
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Measured as centimetre (cm).
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From baseline (week 0) to week 84 and week 136
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Change in systolic blood pressure (SBP)
Time Frame: From baseline (week 0) to week 84 and week 136
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Measured as millimetre of mercury (mmHg).
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From baseline (week 0) to week 84 and week 136
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Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score
Time Frame: From baseline (week 0) to week 84 and week 136
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Measured as score on a scale.
IWQOL-Lite-CT measures weight-related physical and psychosocial functioning.
The measure consists of 20 items yielding 3 composite scores, and 1 total score.
Higher scores indicate better levels of functioning.
The physical function score ranges from 0-100.
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From baseline (week 0) to week 84 and week 136
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Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score
Time Frame: From baseline (week 0) to week 84 and week 136
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Measured as score on a scale.
SF-36v2 Acute measures Health-Related Quality of Life (HRQOL).
The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores.
SF-36v2 Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation (SD) of 10.
Higher scores indicate better functional health and well-being.
The physical functioning ranges from 19.0 to 57.6.
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From baseline (week 0) to week 84 and week 136
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Change in body weight
Time Frame: From baseline (week 0) to week 84 and week 136
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Measured as kilogram (kg).
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From baseline (week 0) to week 84 and week 136
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Change in body mass index (BMI)
Time Frame: From baseline (week 0) to week 84 and week 136
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Measured as kilograms per meter squared (kg/m^2).
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From baseline (week 0) to week 84 and week 136
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Change in IWQOL-Lite-CT physical composite score
Time Frame: From baseline (week 0) to week 84 and week 136
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Measured as score on a scale.
IWQOL-Lite-CT measures weight-related physical and psychosocial functioning.
The measure consists of 20 items yielding 3 composite scores, and 1 total score.
Higher scores indicate better levels of functioning.
The physical composite score ranges from 0-100.
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From baseline (week 0) to week 84 and week 136
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Change in IWQOL-Lite-CT psychosocial composite score
Time Frame: From baseline (week 0) to week 84 and week 136
|
Measured as score on a scale.
IWQOL-Lite-CT measures weight-related physical and psychosocial functioning.
The measure consists of 20 items yielding 3 composite scores, and 1 total score.
Higher scores indicate better levels of functioning.
The psychosocial composite score ranges from 0-100.
|
From baseline (week 0) to week 84 and week 136
|
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Change in IWQOL-Lite-CT total score
Time Frame: From baseline (week 0) to week 84 and week 136
|
Measured as score on a scale.
IWQOL-Lite-CT measures weight-related physical and psychosocial functioning.
The measure consists of 20 items yielding 3 composite scores, and 1 total score.
Higher scores indicate better levels of functioning.
The total score ranges from 0-100.
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From baseline (week 0) to week 84 and week 136
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Change in glycated haemoglobin (HbA1c)
Time Frame: From baseline (week 0) to week 84 and week 136
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Measured as percentage of HbA1c.
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From baseline (week 0) to week 84 and week 136
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Change in fasting plasma glucose (FPG)
Time Frame: From baseline (week 0) to week 84 and week 136
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Measured as millimole per liter (mmol/L).
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From baseline (week 0) to week 84 and week 136
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Ratio to baseline: change in fasting insulin
Time Frame: From baseline (week 0) to week 84 and week 136
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Measured as ratio.
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From baseline (week 0) to week 84 and week 136
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Change in diastolic blood pressure (DBP)
Time Frame: From baseline (week 0) to week 84
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Measured as mmHg.
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From baseline (week 0) to week 84
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Ratio to baseline: change in total cholesterol
Time Frame: From baseline (week 0) to week 84 and week 136
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Measured as ratio.
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From baseline (week 0) to week 84 and week 136
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Ratio to baseline: change in high-density lipoprotein (HDL) cholesterol
Time Frame: From baseline (week 0) to week 84 and week 136
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Measured as ratio.
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From baseline (week 0) to week 84 and week 136
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Ratio to baseline: change in low-density lipoprotein (LDL) cholesterol
Time Frame: From baseline (week 0) to week 84 and week 136
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Measured as ratio.
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From baseline (week 0) to week 84 and week 136
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Ratio to baseline: change in very low-density lipoprotein (VLDL) cholesterol
Time Frame: From baseline (week 0) to week 84 and week 136
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Measured as ratio.
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From baseline (week 0) to week 84 and week 136
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Ratio to baseline: change in non-HDL cholesterol
Time Frame: From baseline (week 0) to week 84 and week 136
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Measured as ratio.
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From baseline (week 0) to week 84 and week 136
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Ratio to baseline: change in triglycerides
Time Frame: From baseline (week 0) to week 84 and week 136
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Measured as ratio.
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From baseline (week 0) to week 84 and week 136
|
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Ratio to baseline: change in high-sensitivity C-reactive protein (hsCRP)
Time Frame: From baseline (week 0) to week 84 and week 136
|
Measured as ratio.
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From baseline (week 0) to week 84 and week 136
|
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Number of treatment emergent adverse events (TEAEs)
Time Frame: From baseline (week 0) to week 84 and week 140
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Measured as events.
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From baseline (week 0) to week 84 and week 140
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Number of treatment emergent serious adverse events (TESAEs)
Time Frame: From baseline (week 0) to week 84 and week 140
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Measured as events.
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From baseline (week 0) to week 84 and week 140
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Number of TEAEs leading to permanent treatment discontinuation
Time Frame: From baseline (week 0) to week 84 and week 140
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Measured as events.
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From baseline (week 0) to week 84 and week 140
|
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Relative change in body weight
Time Frame: From baseline (week 0) to week 136
|
Measured as % of body weight.
|
From baseline (week 0) to week 136
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- NN9490-8021
- U1111-1313-6262 (Other Identifier: World Health Organization (WHO))
- 2024-520440-42 (Other Identifier: European Medical Agency (EMA))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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