NCT07184086

A Study to See How Metabolism is Influenced by Weight Loss Due to Intervention With Cagrilintide and Semaglutide Compared to Diet

The Effect of Cagrilintide and Semaglutide Combination Treatment Compared to a Weight-loss Inducing Diet on Energy Metabolism in Persons Living With Obesity: an Open-label Randomised Study

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

In this study we will be looking into how CagriSema influences metabolism (the process by which food is used to supply energy for the body) compared to a diet. CagriSema is a new investigational medicine. CagriSema cannot yet be prescribed by doctors but has previously been tested in humans. The study is split into 2 parts. In the first part of the study, participants will either get CagriSema or a weight loss diet (calorie reduced). In the second part of the study,all participants will get CagriSema. Which treatment participants get in the first part of the study is decided by chance. Like all medicines, the study medicine may have side effects. The study will last for about 1.5 years.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	CagriSema (Cagrilintide B + semaglutide I)	Cagrilintide and semaglutide will be administered subcutaneously.
BEHAVIORAL	Low Energy Diet	Participants will receive dietary intervention as per diet intervention manual.

Timeline

• Start date: 2025-09-26
• Primary completion: 2027-10-12
• Completion: 2027-10-12
• First posted: 2025-09-19
• Last updated: 2025-10-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study