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Clinical Trials in Denmark / NCT07527195
Recruiting Phase 1

Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscle Health)

NCT07527195 · tracked via the Priya Life Science Denmark tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 1
Started
2026-04-10
Last updated
2026-05-07

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

Cagrilintide →Semaglutide →Placebo cagrilintidePlacebo semaglutide

Cagrilintide: Participants will receive cagrilintide subcutaneously.

Semaglutide: Participants will receive semaglutide subcutaneously.

Placebo cagrilintide: Participants will receive placebo matched to cagrilintide subcutaneously.

Placebo semaglutide: Participants will receive placebo matched to semaglutide subcutaneously.

Study summary

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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
70 Years
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.

Primary outcome measure(s)

  • Change in insulin-stimulated fluorodeoxyglucose (FDG) uptake in skeletal muscle — Baseline to Week 51
    Measured in micromoles per 100 grams per minute (μmol/100g/min).

Trial sites (1)

FacilityCityRegionStatus
Aarhus Universitetshospital, Steno Diabetes Center Aarhus Aarhus N Denmark Recruiting

On this site

📄 Ozempic (semaglutide) drug profile →

More Novo Nordisk A/S trials in Denmark

Adverse Event Data Collection From the EUHASS Registry on Turoctocog Alfa Pegol Enrolling by invitation
A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity Active, not recruiting
REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels Active, not recruiting
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight Recruiting
Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH) Active, not recruiting

Other trials for the same condition

Intensive Weight Loss Intervention Versus Bariatric Surgery for Adults With Severe and Complex Obesity: the LightBAR Randomised Trial Recruiting
A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity Active, not recruiting
The MULTISITE Study Active, not recruiting
Efficacy and Safety of KBP-336 in Obese Individuals with Osteoarthritis Recruiting
A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07527195 on ClinicalTrials.gov ↗ ← All trials in Denmark