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The Role of the Amylin Analogue Cagrilintide in Bone Metabolism

NCT07010432 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2025-07-25

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency (dept. 2834) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-12
Primary Completion
2028-05-03
Completion
2028-05-03

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07010432 on ClinicalTrials.gov