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

Sponsor
Novo Nordisk A/S
Study ID
NCT07527195
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Apr 10, 2026
Status verified
May 2026
Primary completion
Apr 28, 2028
Completion
Jun 9, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CagriSema
    Participants will receive once weekly subcutaneous (s.c.) dose of CagriSema (cagrilintide and semaglutide) for up to 52 weeks.
  • Experimental: Semaglutide
    Participants will receive once weekly s.c. dose of semaglutide for up to 52 weeks.
  • Experimental: Cagrilintide
    Participants will receive once weekly s.c. dose of cagrilintide for up to 52 weeks.
  • Placebo Comparator: Placebo
    Participants will receive once weekly s.c. dose of placebo matched to cagrilintide/semaglutide for up to 52 weeks.

Primary Outcome Measure

Change in insulin-stimulated fluorodeoxyglucose (FDG) uptake in skeletal muscle [ Time Frame: Baseline to Week 51 ]

Central Contacts

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