DRUG
Cagrilintide
Cagrilintide will be administered subcutaneously.
A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight
Status
Completed
Phase
Phase 3
Enrollment
809
Locations
46
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
This study will look at how well CagriSema compared to Tirzepatide helps people lower their body weight. CagriSema is a new investigational medicine developed by Novo Nordisk that combines Cagrilintide and Semaglutide. CagriSema is not yet being prescribed by doctors. Participant will get injections once a week throughout the treatment period. Participant will inject the study medicine under the skin with a pen injector in the thigh, stomach, or upper arm. After a first low dose, the study medicine will be gradually increased until reaching the planned dose (2.4 mg CagriSema or 15 mg Tirzepatide). The study will last for about one and a half year for each participant.
Interventions
Treatment arms and agents.
DRUG
Semaglutide
Semaglutide will be administered subcutaneously.
DRUG
Tirzepatide
Tirzepatide will be administered subcutaneously.
Timeline
From registration to results.
First posted
Nov 14, 2023
Study start
Nov 27, 2023
Primary completion
Dec 8, 2025
Study completion
Jan 9, 2026
Results posted
Not reported
Registry updated
Feb 6, 2026
Outcomes
What the study measures.
Primary outcomes
To confirm non-inferiority of CagriSema versus tirzepatide: Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 84)
Measured in percentage (%).
Secondary outcomes
To confirm superiority of CagriSema versus tirzepatide: Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 84)
Measured in percentage (%).
Achievement of greater than or equal to (≥) 25% weight reduction
Time frame · From baseline (week 0) to end of treatment (week 84)
Count of participants.
Achievement of ≥ 30% weight reduction
Time frame · From baseline (week 0) to end of treatment (week 84)
Count of participants.
Change in waist circumference
Time frame · From baseline (week 0) to end of treatment (week 84)
Measured in centimeter (cm).
Change in systolic blood pressure (SBP)
Time frame · From baseline (week 0) to end of treatment (week 84)
Measured in millimeter of mercury (mmHg).
Change in diastolic blood pressure (DBP)
Time frame · From baseline (week 0) to end of treatment (week 84)
Measured in mmHg.
Relative change in lipids: Total cholesterol
Time frame · From baseline (week 0) to end of treatment (week 84)
Measured in percentage.
Relative change in lipids: High-density lipoprotein (HDL) cholesterol
Time frame · From baseline (week 0) to end of treatment (week 84)
Measured in percentage.
Relative change in lipids: Non-HDL cholesterol
Time frame · From baseline (week 0) to end of treatment (week 84)
Measured in percentage.
Relative change in lipids: Low-density lipoprotein (LDL) cholesterol
Time frame · From baseline (week 0) to end of treatment (week 84)
Measured in percentage.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Male or female * Age 18 years or above at the time of signing the informed consent * Body mass index (BMI) of ≥ 30.0 kilogram per square meter (kg/m\^2) 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 mellitus
Study locations
46 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Univ of Alabama Birmingham
Birmingham, Alabama, United States
Chambliss Clinical Trials LLC
Montgomery, Alabama, United States
FDRC
Costa Mesa, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Univ of Colorado at Denver
Aurora, Colorado, United States
Yale University School Of Medicine
New Haven, Connecticut, 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
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
Comprehensive Weight Ctrl Prog
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Medication Mgmnt, LLC_Grnsboro
Greensboro, North Carolina, United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, United States
Accellacare_NC
Raleigh, North Carolina, United States
Accellacare
Wilmington, North Carolina, United States
New Venture Medical Research
Wadsworth, Ohio, United States
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.