RecruitingPhase 1NCT07527195

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

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


Sponsor

Novo Nordisk A/S

Enrollment

100 participants

Start Date

Apr 10, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 50 YearsMax Age: 70 Years

Inclusion Criteria5

  • 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 Criteria4

  • 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.

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Interventions

DRUGCagrilintide

Participants will receive cagrilintide subcutaneously.

DRUGSemaglutide

Participants will receive semaglutide subcutaneously.

DRUGPlacebo cagrilintide

Participants will receive placebo matched to cagrilintide subcutaneously.

DRUGPlacebo semaglutide

Participants will receive placebo matched to semaglutide subcutaneously.


Locations(1)

Aarhus Universitetshospital, Steno Diabetes Center Aarhus

Aarhus N, Denmark

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NCT07527195


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