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RecruitingNCT07527195RASMUSUpdated May 7, 2026

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

A Phase 1 interventional study of Cagrilintide and Semaglutide in Obesity, sponsored by Novo Nordisk A/S. Recruiting at 1 site in Denmark. Open to participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-07.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 5 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
50 Years to 70 Years
Sex
All
01

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.

02

Conditions studied

  • Obesity

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03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 100 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    CagriSema

    Participants will receive once weekly subcutaneous (s.c.) dose of CagriSema (cagrilintide and semaglutide) for up to 52 weeks.

    Drug: Cagrilintide · Drug: Semaglutide

  • Experimental
    Semaglutide

    Participants will receive once weekly s.c. dose of semaglutide for up to 52 weeks.

    Drug: Semaglutide · Drug: Placebo semaglutide

  • Experimental
    Cagrilintide

    Participants will receive once weekly s.c. dose of cagrilintide for up to 52 weeks.

    Drug: Cagrilintide · Drug: Placebo cagrilintide

  • Placebo comparator
    Placebo

    Participants will receive once weekly s.c. dose of placebo matched to cagrilintide/semaglutide for up to 52 weeks.

    Drug: Placebo cagrilintide · Drug: Placebo semaglutide

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.

06

What researchers measure

Primary outcomes

  1. Change in insulin-stimulated fluorodeoxyglucose (FDG) uptake in skeletal muscle

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

    Time frame: Baseline to Week 51

Secondary outcomes

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

    Measured in μmol/100g/min.

    Time frame: Baseline to Week 20

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

    Measured in μmol/100g/min.

    Time frame: Baseline to Week 51

07

Study locations

1 of 1 sites recruiting
  • Aarhus Universitetshospital, Steno Diabetes Center Aarhus
    Aarhus N, 8200, Denmark
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07527195
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Apr 14, 2026
Start date
Apr 10, 2026
Primary completion
Apr 28, 2028 (estimated)
Completion
Jun 9, 2028 (estimated)
Last update
May 7, 2026

Study contacts

Novo Nordisk
Contact
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Clinical Transparency dept. 2834
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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