DRUG
Cagrilintide
Participants will receive cagrilintide subcutaneously.
Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscle Health)
Status
Recruiting
Phase
Phase 1
Enrollment
100
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Treatment arms and agents.
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.
Timeline
From registration to results.
First posted
Apr 14, 2026
Study start
Apr 10, 2026
Primary completion
Apr 28, 2028
Study completion
Jun 9, 2028
Results posted
Not reported
Registry updated
May 7, 2026
Outcomes
What the study measures.
Primary outcomes
Change in insulin-stimulated fluorodeoxyglucose (FDG) uptake in skeletal muscle
Time frame · Baseline to Week 51
Measured in micromoles per 100 grams per minute (μmol/100g/min).
Secondary outcomes
Change in insulin-stimulated FDG uptake in skeletal muscle
Time frame · Baseline to Week 20
Measured in μmol/100g/min.
Change in insulin-stimulated FDG uptake in skeletal muscle
Time frame · Baseline to Week 51
Measured in μmol/100g/min.
Eligibility
Who can take part.
- Minimum age
- 50 Years
- Maximum age
- 70 Years
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
1 registered sites.
Denmark. Showing up to 24 locations stored in the fast local snapshot.
Aarhus Universitetshospital, Steno Diabetes Center Aarhus
Aarhus N, Denmark
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Cagrilintide.
NCT IDStudyPhase / statusEnrollmentUpdated
A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight
Novo Nordisk · Obesity · Type 2 Diabetes
Phase 3
Recruiting
2,500
2026-07
A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term
Novo Nordisk · Obesity
Phase 3
Active, not recruiting
609
2026-07
A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight
Novo Nordisk · Obesity
Phase 3
Active, not recruiting
3,400
2026-07
REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels
Novo Nordisk · Cardiovascular Disease
Phase 3
Active, not recruiting
7,101
2026-07
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both
Novo Nordisk · Diabetes Mellitus, Type 2
Phase 3
Completed
1,023
2026-07
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
Novo Nordisk · Overweight · Obesity
Phase 3
Recruiting
460
2026-07
A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes
Novo Nordisk · Diabetes Mellitus, Type 2
Phase 2
Withdrawn
0
2026-07
A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight
Novo Nordisk · Overweight · Obesity
Phase 3
Withdrawn
0
2026-07
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.