Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscle Health)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cagrilintide, Semaglutide, Placebo cagrilintide, Placebo semaglutide.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 50 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of CagriSema, Semaglutide and Cagrilintide on Skeletal Muscle Insulin Sensitivity, Composition and Function
Overview
The purpose of this clinical study is to look into how study medicines CagriSema (cagrilintide and semaglutide), cagrilintide, and semaglutide affects muscle health in people with excess body weight and slightly higher than normal blood sugar as they lose weight. Participants will either get CagriSema (a new study drug), cagrilintide (a new study drug), semaglutide (a drug that doctors can already prescribe to treat people with type 2 diabetes and excess body weight) or placebo (a placebo looks like the treatment being tested but doesn't have any active ingredients in it). Which treatment participants will get is decided by chance. Participants will be in this clinical study up to 15 months.
Interventions
- Drug Cagrilintide
Participants will receive cagrilintide subcutaneously. - Drug Semaglutide
Participants will receive semaglutide subcutaneously. - Drug Placebo cagrilintide
Participants will receive placebo matched to cagrilintide subcutaneously. - Drug Placebo semaglutide
Participants will receive placebo matched to semaglutide subcutaneously.
Primary outcome measures
- Change in insulin-stimulated fluorodeoxyglucose (FDG) uptake in skeletal muscle [Time frame: Baseline to Week 51]
Secondary outcome measures (2)
- Change in insulin-stimulated FDG uptake in skeletal muscle [Time frame: Baseline to Week 20]
- Change in insulin-stimulated FDG uptake in skeletal muscle [Time frame: Baseline to Week 51]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Aarhus Universitetshospital, Steno Diabetes Center Aarhus — Aarhus N
Identifiers
NCT: NCT07527195 · NN9838-8411 · U1111-1321-8655 · 2025-522920-28