The Role of the Amylin Analogue Cagrilintide in Bone Metabolism

NCT ID: NCT07010432

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-12
• Study Completion Date: 2028-05-03

Brief Summary

In this study we will investigate how the medicine cagrilintide affects bone health in women after menopause with obesity during weight loss, compared to treatment with placebo (the dummy medicine with no active substances) and semaglutide. The purpose is to examine whether cagrilintide can reduce the decline in bone mass associated to weight loss. Participants will either get cagrilintide, semaglutide, CagriSema (cagrilintide combined with semaglutide), or placebo. Which treatment participants get is decided by chance. Semaglutide is already approved for the treatment of overweight and obesity and can be prescribed by doctors. Cagrilintide and CagriSema are new medications currently under development for weight management. The study will last for about 79 weeks.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cagrilintide

Participants will receive once-weekly subcutaneous (s.c) injections of cagrilintide or placebo at stepwise doses every 4 weeks in a 16-week dose escalation period until target dose is achieved and maintained for 52 weeks as adjunct to a reduced calorie diet.

Group Type: EXPERIMENTAL

Cagrilintide

Intervention Type: DRUG

Participants will receive once-weekly cagrilintide subcutaneously.

Placebo cagrilintide

Intervention Type: DRUG

Participants will receive once-weekly placebo matched to cagrilintide subcutaneously.

Semaglutide

Participants will receive once-weekly s.c injections of semaglutide or placebo at stepwise doses every 4 weeks in a 16 week dose escalation period until target dose is achieved and maintained for 52 weeks as adjunct to a reduced calorie diet.

Group Type: EXPERIMENTAL

Semaglutide

Intervention Type: DRUG

Participants will receive once-weekly semaglutide subcutaneously.

Placebo semaglutide

Intervention Type: DRUG

Participants will receive once-weekly placebo matched to semaglutide subcutaneously.

CagriSema

Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) or placebo at stepwise doses every 4 weeks in a 16 week dose escalation period until target dose is achieved and maintained for 52 weeks as adjunct to a reduced calorie diet.

Group Type: EXPERIMENTAL

Cagrilintide

Intervention Type: DRUG

Participants will receive once-weekly cagrilintide subcutaneously.

Semaglutide

Intervention Type: DRUG

Participants will receive once-weekly semaglutide subcutaneously.

Placebo cagrilintide

Intervention Type: DRUG

Participants will receive once-weekly placebo matched to cagrilintide subcutaneously.

Placebo semaglutide

Intervention Type: DRUG

Participants will receive once-weekly placebo matched to semaglutide subcutaneously.

Placebo

Participants will receive once-weekly s.c injection of placebo matched to semaglutide and cagrilintide for 68 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo cagrilintide

Intervention Type: DRUG

Participants will receive once-weekly placebo matched to cagrilintide subcutaneously.

Placebo semaglutide

Intervention Type: DRUG

Participants will receive once-weekly placebo matched to semaglutide subcutaneously.

Interventions

Cagrilintide

Participants will receive once-weekly cagrilintide subcutaneously.

Intervention Type: DRUG

Semaglutide

Participants will receive once-weekly semaglutide subcutaneously.

Intervention Type: DRUG

Placebo cagrilintide

Participants will receive once-weekly placebo matched to cagrilintide subcutaneously.

Intervention Type: DRUG

Placebo semaglutide

Participants will receive once-weekly placebo matched to semaglutide subcutaneously.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Female.
• Post-menopausal at screening (defined as minimum 12 months of amenorrhea, high levels of follicular stimulating hormone (FSH) 16 - 130 international units per liter (IU/L), and low levels of anti-müllerian hormone (AMH) and inhibin B).
• Age 50-70 years (both inclusive) at the time of signing the informed consent.
• Body Mass Index (BMI) greater than or equal to >= 30.0 kilograms per square meter (kg/m^2).

Exclusion Criteria

• Previous or current bone disease (e.g., osteoporosis, Paget's disease of bone, or bone cancer).
• Presence of disease affecting bone metabolism (e.g., diabetes mellitus, hyperparathyroidism, hyper or hypothyroidism, chronic kidney disease, celiac disease, or inflammatory diseases (e.g., psoriatic arthritis or ankylosing spondylitis)).
• Treatment with any medication affecting bone metabolism within 6 months prior to screening as judged by the investigator (e.g., anti-resorptive medication, anabolic medication, systemic hormone replacement therapy (HRT), or systemic corticosteroids).

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Steno Diabetes Center Copenhagen

Herlev, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Novo Nordisk

Role: CONTACT

clinicaltrials@novonordisk.com

(+1) 866-867-7178

Other Identifiers

U1111-1313-0864

Identifier Type: OTHER

Identifier Source: secondary_id

2024-517883-49

Identifier Type: OTHER

Identifier Source: secondary_id

NN9388-8175

Identifier Type: -

Identifier Source: org_study_id