The Role of the Amylin Analogue Cagrilintide in Bone Metabolism

NCT07010432 · Recruiting

Last updated 2026-05-28

This clinical trial is testing whether the medication cagrilintide, an amylin analogue, affects bone density in people with obesity.

Status Recruiting Currently enrolling participants.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 144 people Planned (estimated).

Who can join Ages 50–70 · female only

Timeline Started 2025-06 · est. completion 2028-05

Where 1 site · Denmark

What this study is testing ClinicalTrials.gov NCT07010432 ↗

Description as written by the study sponsor.

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.

Treatments tested

Cagrilintide Drug

Participants will receive once-weekly cagrilintide subcutaneously.
Semaglutide Drug

Participants will receive once-weekly semaglutide subcutaneously.
Placebo cagrilintide Drug

Participants will receive once-weekly placebo matched to cagrilintide subcutaneously.
Placebo semaglutide Drug

Participants will receive once-weekly placebo matched to semaglutide subcutaneously.

Main thing measured	Relative change in volumetric bone mineral density (vBMD) of the total hip assessed by quantitative computed tomography (QCT)
Sponsor	Novo Nordisk A/S
Conditions studied	Obesity
GLP-1 drugs	cagrilintide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07010432 ↗