DRUG
CagriSema (Cagrilintide B and Semaglutide I)
CagriSema (Cagrilintide B and Semaglutide I) will be administered subcutaneously using DV3384 pen-injector.
A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term
Status
Active, not recruiting
Phase
Phase 3
Enrollment
609
Locations
46
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
This study will look at how well CagriSema helps people living with obesity to lose weight and maintain the weight loss long-term. The study has 2 parts: The first part is called 'the main study' and the second part is called 'the extension study'. In the main study participants will either get CagriSema (a study medicine) or placebo (a dummy medicine that looks like CagriSema but has no active ingredient). Which treatment participants get is decided by chance. Participants are two times more likely to get CagriSema than placebo. If participants get CagriSema in the main study, participants will continue on CagriSema in the extension study. Which dose of CagriSema participants will continue on is decided by chance. If participants get placebo in the main study, participants will get CagriSema in the extension study. Participants will take one injection of study medicine once a week. The study will last for about 3 years and 3 months.
Interventions
Treatment arms and agents.
DRUG
Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)
Placebo matched to Cagrilintide B and placebo matched to Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
Timeline
From registration to results.
First posted
Jun 9, 2025
Study start
Jun 3, 2025
Primary completion
Mar 1, 2027
Study completion
Oct 17, 2028
Results posted
Not reported
Registry updated
Jul 24, 2026
Outcomes
What the study measures.
Primary outcomes
Relative change in body weight
Time frame · From baseline (week 0) to week 80
Measured as percentage change.
Secondary outcomes
Relative change in body weight in women
Time frame · From baseline (week 0) to week 80
Measured as percentage change.
Number of participants who achieve greater than or equals (≥) 20% weight reduction
Time frame · From baseline (week 0) to week 80
Measured as count of participants.
Number of participants who achieve ≥ 25% weight reduction
Time frame · From baseline (week 0) to week 80
Measured as count of participants.
Number of participants who achieve ≥ 30% weight reduction
Time frame · From baseline (week 0) to week 80
Measured as count of participants.
Number of participants who achieve BMI < 30 kg/m^2
Time frame · From baseline (week 0) to week 80
Measured as count of participants.
Number of participants who achieve normal body mass index (BMI) (18.5 kilograms per meter square (kg/m^2) less than or equal to (≤ ) BMI < 25 kg/m^2)
Time frame · From baseline (week 0) to week 80
Measured as count of participants.
Change in waist circumference
Time frame · From baseline (week 0) to week 80
Measured as centimeter (cm).
Change in systolic blood pressure
Time frame · From baseline (week 0) to week 80
Measured as millimeters of mercury (mmHg).
Ratio to baseline in C-reactive protein (CRP)
Time frame · From baseline (week 0) to week 80
Measured as ratio.
Ratio to baseline in lipids: non-high density lipoprotein (HDL) cholesterol
Time frame · From baseline (week 0) to week 80
Measured as ratio.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
key Inclusion Criteria: * Male or female (sex at birth). * Age 18 years or above at the time of signing the informed consent. * BMI ≥ 30.0 kilogram per square meter (kg/m\^2) at screening. * Participant has a wish to lose at least 25% of body weight within 80 weeks from randomisation. key Exclusion Criteria: * Glycated haemoglobin (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.
Study locations
46 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
FDRC
Costa Mesa, California, United States
Linda Vista Health Care Ctr
San Diego, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Northeast Research Institute
Fleming Island, Florida, United States
Jacksonville Ctr For Clin Res
Jacksonville, Florida, United States
South Broward Research LLC
Miramar, Florida, United States
Florida Inst For Clin Res LLC
Orlando, Florida, United States
Oviedo Medical Research, LLC
Oviedo, Florida, United States
Center for Diab,Obes & Metab
Pembroke Pines, Florida, United States
Hope Clin Res & Wellness
Conyers, Georgia, United States
Endocrine Research Solutions
Roswell, Georgia, 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
Iowa Diab & Endo Res Center
West Des Moines, Iowa, United States
Northern Pines Hlth Ctr, PC
Buckley, Michigan, United States
StudyMetrix Research LLC
City of Saint Peters, Missouri, United States
Amicis Centers of Clinical Research
St Louis, Missouri, United States
Mercury Str Med Grp, PLLC
Butte, Montana, United States
Southgate Medical Group, LLP
West Seneca, New York, United States
Great Lakes Medical Research
Westfield, New York, 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.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.