NCT07220759

Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide

Efficacy and Safety of Cagrilintide for Weight Management in Participants With Overweight or Obesity and Type 2 Diabetes

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will look at how much cagrilintide helps people with overweight or obesity and type 2 diabetes lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participant will either get cagrilintide or placebo. Which treatment participant get is decided by chance. Participants are two times more likely to get cagrilintide than placebo. Like all medicines, the study medicine may have side effects. For each participant, the study will last for about 1 year and 6 months.

Conditions

• Overweight
• Obesity
• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Cagrilintide	Cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.
DRUG	Placebo (matched to Cagrilintide)	Placebo matched to cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.

Timeline

• Start date: 2025-11-05
• Primary completion: 2027-05-12
• Completion: 2027-06-30
• First posted: 2025-10-24
• Last updated: 2026-03-06

Locations

67 sites across 11 countries: United States, Argentina, Canada, Croatia, Czechia, Hungary, Romania, Slovakia, South Korea, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study