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

NCT07527195 | Not Yet Recruiting Phase 1 FDA Drug

• 3 other identifiers: NN9838-8411U1111-1321-86552025-522920-28
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline to Week 51

Secondary Outcomes (2)

• Change in insulin-stimulated FDG uptake in skeletal muscle

  Baseline to Week 20

• Change in insulin-stimulated FDG uptake in skeletal muscle

  Baseline to Week 51

Study Arms (4)

CagriSema

EXPERIMENTAL

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

Drug: Cagrilintide; Drug: Semaglutide

Semaglutide

EXPERIMENTAL

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

Drug: Semaglutide; Drug: Placebo semaglutide

Cagrilintide

EXPERIMENTAL

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

Drug: Cagrilintide; Drug: Placebo cagrilintide

Placebo

PLACEBO COMPARATOR

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

Cagrilintide DRUG

Participants will receive cagrilintide subcutaneously.

CagriSema; Cagrilintide

Semaglutide DRUG

Participants will receive semaglutide subcutaneously.

CagriSema; Semaglutide

Placebo cagrilintide DRUG

Participants will receive placebo matched to cagrilintide subcutaneously.

Cagrilintide; Placebo

Placebo semaglutide DRUG

Participants will receive placebo matched to semaglutide subcutaneously.

Placebo; Semaglutide

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Aarhus Universitetshospital, Steno Diabetes Center Aarhus

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Obesity

Interventions

cagrilintide; semaglutide

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): April 28, 2028
• Study Completion (Estimated): June 9, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)