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Clinical Trials in India / NCT05567796
Active, not recruiting Phase 3

A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight

NCT05567796 · tracked via the Priya Life Science India tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 3
Started
2022-11-01
Last updated
2026-08-31

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

CagrilintideSemaglutidePlacebo cagrilintidePlacebo semaglutide

Cagrilintide: Cagrilintide will be administered subcutaneously.

Semaglutide: Participants will recieve semaglutide subcutaneously.

Placebo cagrilintide: Participants will receive placebo matched to cagrilintide.

Placebo semaglutide: Participants will receive placebo matched to semaglutide.

Study summary

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.

Eligibility

Sex
ALL
Min age
Max age
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

Primary outcome measure(s)

Trial sites (256)

FacilityCityRegionStatus
Univ of Alabama Birmingham Birmingham Alabama
Velocity Clin Res Los Angeles Los Angeles California
Velocity Clin Res Wstlke Los Angeles California
Univ of Colorado at Denver Aurora Colorado
OptumCare Clinical Trials LLC Golden Colorado
Northeast Research Institute Fleming Island Florida
South Broward Research LLC Miramar Florida
Clinical Neuroscience Solution Orlando Florida
Florida Inst For Clin Res Orlando Florida
Florida Institute for Clinical research Orlando Florida
Clinical Trial Res Assoc,Inc Plantation Florida
Hope Clin Res & Wellness Conyers Georgia
East West Med Res Inst Honolulu Hawaii
Great Lakes Clinical Trials Chicago Illinois
Endeavor Health Skokie Illinois
Evanston Premier Hlthcr Res Skokie Illinois
Midwest Inst For Clin Res Indianapolis Indiana
Northern Pines Hlth Ctr, PC Buckley Michigan
StudyMetrix Research LLC City of Saint Peters Missouri
Velocity Clinical Research Binghamton Binghamton New York
Comprehensive Weight Ctrl Prog New York New York
University of North Carolina Chapel Hill North Carolina
University of North Carolina Chapel Hill North Carolina
Medication Mgmnt, LLC_Grnsboro Greensboro North Carolina
PharmQuest Life Sciences LLC Greensboro North Carolina
Accellacare_NC Raleigh North Carolina
Accellacare Wilmington North Carolina
New Venture Medical Research Wadsworth Ohio
Lynn Institute of Norman Norman Oklahoma
The University of Penn Center Philadelphia Pennsylvania
Clinical Res Collaborative Cumberland Rhode Island
Medical Uni of SC Charleston Charleston South Carolina
Coastal Carolina Res Ctr North Charleston South Carolina
Hillcrest Clinical Research Simpsonville South Carolina
Spartanburg Medical Research Spartanburg South Carolina
Holston Medical Group_Bristol Bristol Tennessee
Holston Medical Group Kingsport Tennessee
Baylr Sctt White Rs Inst, Endo Dallas Texas
Velocity Clinical Res-Dallas Dallas Texas
UT Southwestern Med Cntr Dallas Texas

+ 216 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05567796 on ClinicalTrials.gov ↗ ← All trials in India