Actively Recruiting
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
On this page
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Steno Diabetes Center Copenhagen
Herlev, Denmark, 2730
Actively Recruiting
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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