Effect of CagriSema, cagrilintide, and semaglutide on muscle health during weight loss
Official title: Effect of CagriSema, Semaglutide and Cagrilintide on Skeletal Muscle Insulin Sensitivity, Composition and Function
Run by Novo Nordisk A/S · NCT07527195 · Data updated 2026-11-12
This trial tests whether CagriSema, cagrilintide, or semaglutide helps preserve muscle health as people aged 50-70 with obesity and mildly elevated blood sugar lose weight.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 50 Years to 70 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 1 site (Aarhus N) |
| Status | Recruiting |
| Started | April 10, 2026 |
| Main results expected | April 28, 2028 |
| Study ends | June 9, 2028 |
| Registry record updated | May 7, 2026 |
| Trial ID | NCT07527195 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 50-70 years old with BMI 30.0–39.9 due to excess adipose tissue, slightly elevated blood sugar, postmenopausal if female, not on GLP‑1 medications, and willing to attempt substantial weight loss over the study period.
✕Probably not a fit
People who recently lost or tried to lose significant weight (≥5% in the prior 90 days), those treated with GLP‑1 receptor agonists within 90 days, premenopausal women, or individuals with leg amputations are unlikely to qualify or benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this Phase 1, randomized, placebo-controlled trial participants are assigned by chance to receive CagriSema (cagrilintide + semaglutide), cagrilintide alone, semaglutide alone, or placebo and are followed for up to 15 months. The study enrolls adults aged 50-70 with BMI 30.0–39.9 and slightly higher-than-normal blood sugar who want to lose substantial weight. Outcomes focus on muscle health measures and the role of an amylin-related signature as participants lose weight. Participants who recently used GLP-1 drugs or had recent significant weight change are excluded to isolate drug effects on muscle.
Why it matters
Potential benefit: If successful, these treatments could allow people to achieve weight loss while better preserving muscle mass and strength, improving mobility and metabolic health.
How similar studies have gone: Semaglutide and cagrilintide combinations have produced large weight loss in other trials, but their specific effects on muscle health and the amylin signature are not well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria * Male or female. * Age 50-70 years (both inclusive) at the time of signing the informed consent. * Body Mass index (BMI) between 30.0 kilograms per square meter (kg/m\^2) and 39.9 kg/m\^2 (both inclusive) at screening (V1). * Excess body weight should be due to excess adipose tissue, as judged by the investigator. * Participant has a wish to lose at least 25 percentage (%) of body weight within 52 weeks of treatment. Exclusion criteria * Any leg amputations. * Female participants who are not postmenopausal at screening. * Any clinically significant body weight change (greater than or equal to \[\>=\] 5% self-reported change) or dieting attempts within 90 days before screening. * Treatment with any glucagon-like peptide-1 (GLP-1) receptor agonist or a medication with GLP-1 activity within 90 days before screening.
Where it's running
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Aarhus Universitetshospital, Steno Diabetes Center Aarhus
Aarhus N, 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
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.