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NCT Number: NCT07527195

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

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.

Recruiting

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Aarhus Universitetshospital, Steno Diabetes Center Aarhus

Aarhus N, 8200, Denmark

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cagrilintide

Drug

Participants will receive cagrilintide subcutaneously.

semaglutide

Drug

Participants will receive semaglutide subcutaneously.

Placebo Cagrilintide

Drug

Participants will receive placebo matched to cagrilintide subcutaneously.

Placebo Semaglutide

Drug

Participants will receive placebo matched to semaglutide subcutaneously.

Primary outcomes

  1. 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

  1. Change in insulin-stimulated FDG uptake in skeletal muscle

    Time frame: Baseline to Week 20

    Measured in μmol/100g/min.

  2. Change in insulin-stimulated FDG uptake in skeletal muscle

    Time frame: Baseline to Week 51

    Measured in μmol/100g/min.

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Effect of CagriSema, Semaglutide and Cagrilintide on Skeletal Muscle Insulin Sensitivity, Composition and Function

Acronym: RASMUS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 14, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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