Actively Recruiting

Phase 1
Age: 50Years - 70Years
FEMALE
NCT07010432

The Role of the Amylin Analogue Cagrilintide in Bone Metabolism

Led by Novo Nordisk A/S · Updated on 2025-07-25

144

Participants Needed

1

Research Sites

150 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

The Role of the Amylin Analogue Cagrilintide in Bone Metabolism

Who Can Participate

Age: 50Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female
  • Post-menopausal at screening defined as minimum 12 months of no menstrual periods, high follicular stimulating hormone (FSH) levels between 16 and 130 IU/L, and low anti-m�fcllerian hormone (AMH) and inhibin B levels
  • Age between 50 and 70 years inclusive at signing informed consent
  • Body Mass Index (BMI) greater than or equal to 30.0 kg/m�b2
Not Eligible

You will not qualify if you...

  • Previous or current bone diseases such as osteoporosis, Paget's disease of bone, or bone cancer
  • Diseases affecting bone metabolism including diabetes mellitus, hyperparathyroidism, thyroid disorders, chronic kidney disease, celiac disease, or inflammatory diseases like psoriatic arthritis or ankylosing spondylitis
  • Treatment with any medication affecting bone metabolism within 6 months before screening, such as anti-resorptive or anabolic medication, systemic hormone replacement therapy, or systemic corticosteroids

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Steno Diabetes Center Copenhagen

Herlev, Denmark, 2730

Actively Recruiting

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Research Team

N

Novo Nordisk

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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