NCT05394519

A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight

Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity and Type 2 Diabetes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,200 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. Which treatment they get is decided by chance. The study will last for about 1½ years. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.

Conditions

• Overweight
• Obesity
• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Cagrilintide	Cagrilintide administered subcutaneously (s.c., under the skin) once-weekly
DRUG	Semaglutide	Semaglutide administered subcutaneously (s.c., under the skin) once-weekly
DRUG	Placebo cagrilintide	Placebo cagrilintide administered subcutaneously (s.c., under the skin) once-weekly
DRUG	Placebo semaglutide	Placebo semaglutide administered subcutaneously (s.c., under the skin) once-weekly

Timeline

• Start date: 2023-02-01
• Primary completion: 2025-01-28
• Completion: 2025-02-03
• First posted: 2022-05-27
• Last updated: 2026-01-28

Locations

179 sites across 13 countries: United States, Austria, Canada, Germany, Hungary, India, Ireland, Japan, Malaysia, Poland, Puerto Rico, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study