DRUG
Cagrilintide
Cagrilintide will be administered subcutaneously.
A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight
Status
Active, not recruiting
Phase
Phase 3
Enrollment
3,400
Locations
256
Results
Not posted
Publications
2
Study summary
What the protocol is testing.
This study has 2 parts: First part is the main study and second part is the extension study. During the main study participants will receive 1 of 4 study medicines. If participants continue in the extension study, they will not receive any study medicine during the extension. The main study will look at how well CagriSema helps participants with excess body weight lose weight compared to a "dummy" medicine and 2 other medicines, cagrilintide and semaglutide. Participants will either get CagriSema, cagrilintide,semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. They will take one injection once a week. The study medicine is injected briefly with a thin needle, typically in the stomach, thighs or upper arms. Extension study: After the main study, not all participants will continue in the extension study. The study staff will tell the participant if they will continue or not into the extension study. In the extension study we will look at what happens to the participant's body weight and diseases related to excess body weight after the participant stops taking the study medicine. The main study will last for about 1½ years and the extension study will last for another 2 years.
Interventions
Treatment arms and agents.
DRUG
Semaglutide
Participants will recieve semaglutide subcutaneously.
DRUG
Placebo cagrilintide
Participants will receive placebo matched to cagrilintide.
DRUG
Placebo semaglutide
Participants will receive placebo matched to semaglutide.
Timeline
From registration to results.
First posted
Oct 5, 2022
Study start
Nov 1, 2022
Primary completion
Oct 30, 2024
Study completion
Oct 19, 2026
Results posted
Not reported
Registry updated
Jul 17, 2026
Outcomes
What the study measures.
Primary outcomes
CagriSema versus placebo: Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in percentage (%)
CagriSema versus placebo: Achievement of greater than or equal to (>=) 5% weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured as count of participants
Secondary outcomes
CagriSema versus placebo: Achievement of >= 20% weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured as count of participant
CagriSema versus placebo: Achievement of >= 25% weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured as count of participant
CagriSema versus placebo: Achievement of >= 30% weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured as count of participant
CagriSema versus cagrilintide and CagriSema versus semaglutide: Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured as percentage (%)
CagriSema versus placebo: Relative change in body weight
Time frame · From baseline (week 0) to week 8
Measured as percentage (%)
CagriSema versus placebo: Relative change in body weight
Time frame · From baseline (week 0) to week 20
Measured as percentage (%)
CagriSema versus placebo: Change in waist circumference
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in centimeters (cm)
CagriSema versus placebo: Change in systolic blood pressure (SBP)
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in millimeters of mercury (mmHg)
CagriSema versus placebo: 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 end of treatment (week 68)
Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score.
CagriSema versus placebo: Change in SF-v2 Health Survey Acute (SF-36 v2 Acute) Physical Functioning Score
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured as score points. The 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 of 10. Higher scores indicate better functional health and well-being.
Eligibility
Who can take part.
- Minimum age
- Not reported
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Male or female * Age above or equal to 18 years at the time of signing informed consent * Body mass index (BMI) greater than or equal to 30.0 kilograms per square meter (kg/m\^2) or b) BMI greater than or equal to 27.0 kg/m\^2 with the presence of at least one weight-related comorbidity including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease Exclusion Criteria: \- Glycaemia related: a) Glycated Haemoglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole \[mmol/mol\]) as measured by the central laboratory at screening b) History of type 1 or type 2 diabetes mellitus
Study locations
256 registered sites.
Argentina · Australia · Belgium · Bulgaria · Canada · Denmark · Finland · France · Germany · India · Italy · Japan · Mexico · Netherlands · Poland · Serbia · South Africa · South Korea · Spain · Taiwan · Turkey (Türkiye) · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Univ of Alabama Birmingham
Birmingham, Alabama, United States
Velocity Clin Res Los Angeles
Los Angeles, California, United States
Velocity Clin Res Wstlke
Los Angeles, California, United States
Univ of Colorado at Denver
Aurora, Colorado, United States
OptumCare Clinical Trials LLC
Golden, Colorado, United States
Northeast Research Institute
Fleming Island, Florida, United States
South Broward Research LLC
Miramar, Florida, United States
Clinical Neuroscience Solution
Orlando, Florida, United States
Florida Inst For Clin Res
Orlando, Florida, United States
Florida Institute for Clinical research
Orlando, Florida, United States
Clinical Trial Res Assoc,Inc
Plantation, Florida, United States
Hope Clin Res & Wellness
Conyers, Georgia, United States
East West Med Res Inst
Honolulu, Hawaii, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Endeavor Health
Skokie, Illinois, United States
Evanston Premier Hlthcr Res
Skokie, Illinois, United States
Midwest Inst For Clin Res
Indianapolis, Indiana, United States
Northern Pines Hlth Ctr, PC
Buckley, Michigan, United States
StudyMetrix Research LLC
City of Saint Peters, Missouri, United States
Velocity Clinical Research Binghamton
Binghamton, New York, United States
Comprehensive Weight Ctrl Prog
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Medication Mgmnt, LLC_Grnsboro
Greensboro, North Carolina, United States
Publications
Results and literature.
PMID 41328546 ↗Verma S, Bottcher M, Brown P, Dicker D, Rubino D, Sbraccia P, Sharma AM, Smedegaard L, Sorrig R, Garvey WT. CagriSema Reduces Blood Pressure in Adults With Overweight or Obesity: REDEFINE 1. Hypertension. 2026 Feb;83(2):e26055. doi: 10.1161/HYPERTENSIONAHA.125.26055. Epub 2025 Dec 2.PMID 40544433 ↗Garvey WT, Bluher M, Osorto Contreras CK, Davies MJ, Winning Lehmann E, Pietilainen KH, Rubino D, Sbraccia P, Wadden T, Zeuthen N, Wilding JPH; REDEFINE 1 Study Group. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2025 Aug 14;393(7):635-647. doi: 10.1056/NEJMoa2502081. Epub 2025 Jun 22.
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