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

Novo Nordisk

Status and phase: Enrolling; Phase 1

Conditions: Obesity

Treatments: Drug: Placebo semaglutide; Drug: Cagrilintide; Drug: Semaglutide; Drug: Placebo cagrilintide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07527195

2025-522920-28 (Other Identifier)

NN9838-8411

U1111-1321-8655 (Other Identifier)

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

100 participants in 4 patient groups, including a placebo group

CagriSema

Experimental group

Description:

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

Treatment:

Drug: Semaglutide

Drug: Cagrilintide

Semaglutide

Experimental group

Description:

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

Treatment:

Drug: Semaglutide

Drug: Placebo semaglutide

Cagrilintide

Experimental group

Description:

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

Treatment:

Drug: Placebo cagrilintide

Drug: Cagrilintide

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo cagrilintide

Drug: Placebo semaglutide