Clinical trial

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

Recruiting now · Phase 1 · 1 countries · Registry ID NCT07527195

Recruiting nowPhase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age50 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity

Full registry 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.

Treatments and study arms

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

Change in insulin-stimulated fluorodeoxyglucose (FDG) uptake in skeletal muscleBaseline to Week 51

Measured in micromoles per 100 grams per minute (μmol/100g/min).

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Aarhus Universitetshospital, Steno Diabetes Center Aarhus🇩🇰 Aarhus N, Denmark

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