Cagrilintide's effect on bone health during weight loss in postmenopausal women with obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, randomized, double-blind study enrolls postmenopausal women with obesity and assigns them by chance to cagrilintide, semaglutide, a cagrilintide+semaglutide combination (CagriSema), or placebo for about 79 weeks. Bone mass and biochemical markers of bone metabolism will be measured at baseline and at scheduled follow-up visits to track changes during weight loss. The trial aims to determine whether cagrilintide or the combination reduces the decline in bone mass that can accompany weight loss. Safety and tolerability of the study drugs will also be monitored throughout the study period.

Why it matters

Who can join: the full rules

Inclusion criteria

* Female.
* Post-menopausal at screening (defined as minimum 12 months of amenorrhea, high levels of follicular stimulating hormone (FSH) 16 - 130 international units per liter (IU/L), and low levels of anti-müllerian hormone (AMH) and inhibin B).
* Age 50-70 years (both inclusive) at the time of signing the informed consent.
* Body Mass Index (BMI) greater than or equal to \>= 30.0 kilograms per square meter (kg/m\^2).

Exclusion criteria

* Previous or current bone disease (e.g., osteoporosis, Paget's disease of bone, or bone cancer).
* Presence of disease affecting bone metabolism (e.g., diabetes mellitus, hyperparathyroidism, hyper or hypothyroidism, chronic kidney disease, celiac disease, or inflammatory diseases (e.g., psoriatic arthritis or ankylosing spondylitis)).
* Treatment with any medication affecting bone metabolism within 6 months prior to screening as judged by the investigator (e.g., anti-resorptive medication, anabolic medication, systemic hormone replacement therapy (HRT), or systemic corticosteroids).

Where it's running

• Steno Diabetes Center Copenhagen
  Herlev, Denmark Recruiting

Study contacts

• Study coordinator: Novo Nordisk
• Email: clinicaltrials@novonordisk.com
• Phone: (+1) 866-867-7178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.