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

NCT05567796 · Active, not recruiting

Last updated 2026-05-28

This study is testing whether the medication CagriSema helps adults with obesity lose weight compared to a placebo.

Status Active, not recruiting Ongoing, but no longer enrolling new participants.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 3,400 people Planned (estimated).

Who can join all sexes

Timeline Started 2022-11 · est. completion 2026-10

Where 254 sites · Argentina, Australia, Belgium, Bulgaria, Canada, Denmark, Finland, France, Germany, India, Italy, Japan, Mexico, Netherlands, Poland, Serbia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT05567796 ↗

Description as written by the study sponsor.

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.

Treatments tested

Cagrilintide Drug

Cagrilintide will be administered subcutaneously.
Semaglutide Drug

Participants will recieve semaglutide subcutaneously.
Placebo cagrilintide Drug

Participants will receive placebo matched to cagrilintide.
Placebo semaglutide Drug

Participants will receive placebo matched to semaglutide.

Main thing measured	CagriSema versus placebo: Relative change in body weight
Sponsor	Novo Nordisk A/S
Conditions studied	Obesity
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05567796 ↗