Cagrilintide's effect on bone health during weight loss in postmenopausal women with obesity
The Role of the Amylin Analogue Cagrilintide in Bone Metabolism During Weight Loss in Postmenopausal Women With Obesity
This trial will test whether the medicine cagrilintide helps protect bone mass during weight loss in postmenopausal women with obesity compared with semaglutide or placebo.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 50 Years to 70 Years |
| Sex | Female |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 1 site (Herlev) |
| Trial ID | NCT07010432 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Postmenopausal women aged 50–70 with a BMI ≥30 kg/m2 who do not have prior bone disease and meet the study's hormonal criteria.
Not a fit: People with existing bone disease, metabolic or endocrine disorders that affect bone, recent bone-active medication use, or those outside the specified age/BMI range are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, cagrilintide could help preserve bone mass during weight loss in postmenopausal women with obesity, potentially reducing future fracture risk.
How similar studies have performed: Approved GLP-1 drugs like semaglutide are used for weight loss and have mixed early data on bone effects, while cagrilintide and the CagriSema combination are newer and their direct effects on bone remain largely untested in humans.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Herlev
- Steno Diabetes Center Copenhagen — Herlev, Denmark (Recruiting)
Study contacts
- Study coordinator: Novo Nordisk
- Email: clinicaltrials@novonordisk.com
- Phone: (+1) 866-867-7178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.