DRUG
Cagrilintide
Participants will receive cagrilintide subcutaneously.
A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity
Status
Active, not recruiting
Phase
Phase 3
Enrollment
400
Locations
36
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
This study will look at how well CagriSema helps people with obesity lose weight compared to a "dummy medicine". CagriSema is a new medicine developed by Novo Nordisk. CagriSema cannot yet be prescribed by doctors. The study has two parts: First part is called the main phase and will last for 2 years, and second part is called the extension phase and will last for 1 year. In the main phase participants will either get CagriSema or "dummy medicine". Which treatment participants get is decided by chance and is not known by participants or the study doctor. In the extension phase participants will get either CagriSema or slowly reduce participants dose of CagriSema if participants had CagriSema in the main phase. Which treatment participants get is decided by chance and is not known by participants or the study doctor in both phases. If participants had "dummy medicine" in the main phase, participants will get CagriSema in the extension phase. Like all medicines, the study medicine may have side effects.
Interventions
Treatment arms and agents.
DRUG
Semaglutide
Participants will receive semaglutide subcutaneously.
DRUG
Placebo cagrilintide
Participants will receive placebo matched to cagrilintide subcutaneously.
DRUG
Placebo semaglutide
Participants will receive placebo matched to semaglutide subcutaneously.
Timeline
From registration to results.
First posted
Jan 17, 2025
Study start
Feb 10, 2025
Primary completion
Aug 28, 2028
Study completion
Oct 31, 2028
Results posted
Not reported
Registry updated
Jan 20, 2026
Outcomes
What the study measures.
Primary outcomes
Relative change in body weight
Time frame · From baseline (week 0) to week 104
Measured in percentage (%).
Secondary outcomes
Number of participants who achieve greater than or equal to (>=) 20 percent body weight reduction
Time frame · From baseline (week 0) to week 104
Measured as count of participants.
Number of participants who achieve >= 25 percent body weight reduction
Time frame · From baseline (week 0) to week 104
Measured as count of participants.
Number of participants who achieve >= 30 percent body weight reduction
Time frame · From baseline (week 0) to week 104
Measured as count of participants.
Change in waist circumference
Time frame · From baseline (week 0) to week 104
Measured in centimeter (cm).
Change in waist to height ratio
Time frame · From baseline (week 0) to week 104
Measured as ratio.
Change in Systolic Blood Pressure (SBP)
Time frame · From baseline (week 0) to week 104
Measured in millimeter of mercury (mmHg).
Ratio to Baseline in Lipids: Total Cholesterol
Time frame · From baseline (week 0) to week 104
Measured as ratio.
Ratio to Baseline in Lipids: High Density Lipoprotein (HDL) Cholesterol
Time frame · From baseline (week 0) to week 104
Measured as ratio.
Ratio to Baseline in Lipids: Low Density Lipoprotein (LDL) Cholesterol
Time frame · From baseline (week 0) to week 104
Measured as ratio.
Ratio to Baseline in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol
Time frame · From baseline (week 0) to week 104
Measured as 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. * Body mass index (BMI) greater than or equal to (\>=) 35.0 kilograms per meter square (kg/m\^2). Exclusion criteria: * Glycated haemoglobin (HbA1c) \>= 6.5 percent (48 millimoles per mole \[mmol/mol\]) as measured by the central laboratory at screening. * History of type 1 or type 2 diabetes.
Study locations
36 registered sites.
Belgium · Canada · Denmark · Portugal · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Valley Clinical Trials
Covina, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
East West Medical Research Institute_Honolulu
Honolulu, Hawaii, United States
L-MARC Research Center
Louisville, Kentucky, United States
StudyMetrix Research LLC
City of Saint Peters, Missouri, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Holston Medical Group_Bristol
Bristol, Tennessee, United States
North Texas Endocrine Center
Dallas, Texas, United States
Washington Cntr Weight Mgmt
Arlington, Virginia, United States
Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie
Brussels, Belgium
UZA - UZ Antwerpen - Department of Endocrinology
Edegem, Belgium
UZ Leuven - Endocrinology
Leuven, Belgium
CHU Helora - Hôpital de Mons - Site Constantinople
Mons, Belgium
Dr. M.B. Jones Inc
Victoria, British Columbia, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Premier Clinical Trial Research Network (PCTRN)
Hamilton, Ontario, Canada
Alpha Recherche Clinique - Lebourgneuf
Québec, Canada
Aarhus Universitetshospital, Steno Diabetes Center Aarhus
Aarhus, Denmark
Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden
Esbjerg, Denmark
Gentofte Hospital - Center for Klinisk Metabolisk Forskning
Hellerup, Denmark
Hvidovre Hospital Endokrinologisk forsknings afsnit 159
Hvidovre, Denmark
Sjællands Universitetshospital, Køge - Medicinsk Afdeling
Køge, Denmark
ULS De Matosinhos E.P.E.- Hospital Pedro Hispano
Senhora Da Hora, Matosinhos, Matosinhos, Portugal
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.