DRUG
Cagrilintide
Participants will receive once-weekly cagrilintide subcutaneously.
A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight
Status
Completed
Phase
Phase 3
Enrollment
300
Locations
25
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
This study will look at how well CagriSema helps people with excess body weight lose weight. CagriSema is a new medicine developed by Novo Nordisk that combines cagrilintide and semaglutide. CagriSema cannot yet be prescribed by doctors. In the study, participant will either get CagriSema or dummy medicine and which treatment participant get is decided by chance. The study will last for about 1½ years for each participant.
Interventions
Treatment arms and agents.
DRUG
Semaglutide
Participants will receive once-weekly semaglutide subcutaneously.
DRUG
Placebo
Participants will receive once-weekly placebo matched to cagrilintide and semaglutide subcutaneously.
Timeline
From registration to results.
First posted
Apr 29, 2024
Study start
Jun 24, 2024
Primary completion
Apr 22, 2026
Study completion
Apr 22, 2026
Results posted
Not reported
Registry updated
May 5, 2026
Outcomes
What the study measures.
Primary outcomes
Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in percentage (%).
Achievement of ≥5% weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured as count of participant.
Secondary outcomes
Achievement of ≥10% weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured as count of participant.
Achievement of ≥15% weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured as count of participant.
Achievement of ≥20% weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured as count of participant.
Change in waist circumference
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in centimeter (cm).
Change in systolic blood pressure
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in millimeters of mercury.
Ratio to baseline in lipids: Total cholesterol
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
Ratio to baseline in lipids: Triglycerides
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- 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 1. Body Mass index (BMI) greater than or equal to (≥) 30.0 kilogram per meter square (kg/m\^2) or 2. BMI ≥27.0 kg/m2 with the presence of at least one obesity related complication including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease Exclusion Criteria: * Glycated haemoglobin (HbA1c) ≥6.5% (48 millimoles per mole \[mmol/mol\]) as measured by the central laboratory at screening * History of type 1 or type 2 diabetes
Study locations
25 registered sites.
Canada · France · Germany · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Aurora FDRC Inc.
Costa Mesa, California, United States
Clinical Trial Res Assoc,Inc
Plantation, Florida, United States
Midwest Inst For Clin Res
Indianapolis, Indiana, United States
Accellacare
Wilmington, North Carolina, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
Washington Cntr Weight Mgmt
Arlington, Virginia, United States
Capital Clin Res Ctr,LLC
Olympia, Washington, United States
Ocean West Research Clinic
Surrey, British Columbia, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Wharton Medical Clinic Clinical Trials (Hamilton)
Hamilton, Ontario, Canada
Hospices Civils de Lyon-Hopital Lyon Sud-1
Pierre-Bénite, France
Hospices Civils de Lyon-Hopital Lyon Sud
Pierre-Bénite, France
Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec
Saint-Herblain, France
Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil
Toulouse, France
InnoDiab Forschung GmbH
Essen, Germany
Wendisch - Dahl Hamburg - DZHW
Hamburg, Germany
AmBeNet GmbH
Leipzig, Germany
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
Münster, Germany
Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann
Witten, Germany
The Health Centre
Bradford-on-Avon, United Kingdom
Southmead Hospital
Bristol, United Kingdom
Addenbrooke's Hospital_Cambridge
Cambridge, United Kingdom
University Hospital Coventry - WISDEM Centre
Coventry, United Kingdom
Staploe Medical Centre
Soham, United Kingdom
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Cagrilintide.
NCT IDStudyPhase / statusEnrollmentUpdated
A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight
Novo Nordisk · Obesity · Type 2 Diabetes
Phase 3
Recruiting
2,500
2026-07
A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term
Novo Nordisk · Obesity
Phase 3
Active, not recruiting
609
2026-07
A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight
Novo Nordisk · Obesity
Phase 3
Active, not recruiting
3,400
2026-07
REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels
Novo Nordisk · Cardiovascular Disease
Phase 3
Active, not recruiting
7,101
2026-07
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both
Novo Nordisk · Diabetes Mellitus, Type 2
Phase 3
Completed
1,023
2026-07
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
Novo Nordisk · Overweight · Obesity
Phase 3
Recruiting
460
2026-07
A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes
Novo Nordisk · Diabetes Mellitus, Type 2
Phase 2
Withdrawn
0
2026-07
A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight
Novo Nordisk · Overweight · Obesity
Phase 3
Withdrawn
0
2026-07
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.