NCT07010432

The Role of the Amylin Analogue Cagrilintide in Bone Metabolism

The Role of the Amylin Analogue Cagrilintide in Bone Metabolism During Weight Loss in Postmenopausal Women With Obesity

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Female
• Age: 50 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

In this study we will investigate how the medicine cagrilintide affects bone health in women after menopause with obesity during weight loss, compared to treatment with placebo (the dummy medicine with no active substances) and semaglutide. The purpose is to examine whether cagrilintide can reduce the decline in bone mass associated to weight loss. Participants will either get cagrilintide, semaglutide, CagriSema (cagrilintide combined with semaglutide), or placebo. Which treatment participants get is decided by chance. Semaglutide is already approved for the treatment of overweight and obesity and can be prescribed by doctors. Cagrilintide and CagriSema are new medications currently under development for weight management. The study will last for about 79 weeks.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Cagrilintide	Participants will receive once-weekly cagrilintide subcutaneously.
DRUG	Semaglutide	Participants will receive once-weekly semaglutide subcutaneously.
DRUG	Placebo cagrilintide	Participants will receive once-weekly placebo matched to cagrilintide subcutaneously.
DRUG	Placebo semaglutide	Participants will receive once-weekly placebo matched to semaglutide subcutaneously.

Timeline

• Start date: 2025-06-12
• Primary completion: 2028-05-03
• Completion: 2028-05-03
• First posted: 2025-06-08
• Last updated: 2025-07-25

Locations

1 site across 1 country: Denmark