A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Obesity
In brief
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.
Key facts
- Study ID
- NCT05567796
- Run by
- Novo Nordisk A/S
- People needed
- 3400
- Starts
- 2022-11-01
- Expected to finish
- 2026-10-19
- Last updated by the study team
- 2026-07-17
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Velocity Clin Res Los Angeles — Los Angeles, California, United States
- Velocity Clin Res Wstlke — Los Angeles, California, United States
- Univ of Colorado at Denver — Aurora, Colorado, United States
- OptumCare Clinical Trials LLC — Golden, Colorado, United States
- Northeast Research Institute — Fleming Island, Florida, United States
- South Broward Research LLC — Miramar, Florida, United States
- Clinical Neuroscience Solution — Orlando, Florida, United States
- Florida Inst For Clin Res — Orlando, Florida, United States
- Florida Institute for Clinical research — Orlando, Florida, United States
- Clinical Trial Res Assoc,Inc — Plantation, 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
- Velocity Clinical Research Binghamton — Binghamton, New York, United States
- Comprehensive Weight Ctrl Prog — New York, New York, United States
- University of North Carolina — Chapel Hill, North Carolina, 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
- Univ of Alabama Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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