The Role of the Amylin Analogue Cagrilintide in Bone Metabolism

Launched by NOVO NORDISK A/S · May 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called cagrilintide to see how it affects bone health in post-menopausal women with obesity who are trying to lose weight. The goal is to determine if cagrilintide can help prevent the loss of bone mass that often happens during weight loss. Participants will be randomly assigned to receive either cagrilintide, semaglutide (a medication already used for weight management), a combination of both, or a placebo (a dummy treatment with no active ingredients). The study will last about 79 weeks.

To participate in this trial, women need to be between 50 and 70 years old, post-menopausal, and have a body mass index (BMI) of 30 or higher, indicating obesity. However, those with certain bone diseases or conditions that affect bone health, or who have been treated with specific medications for bone health in the past six months, won't be eligible. This trial is not yet recruiting participants, but it aims to contribute valuable information about new treatments for weight management and their impact on bone health.

Gender

FEMALE

Eligibility criteria

• • 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).