The Role of the Amylin Analogue Cagrilintide in Bone Metabolism

NCT07010432 | Recruiting Phase 1

• 3 other identifiers: NN9388-8175U1111-1313-08642024-517883-49
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Relative change in volumetric bone mineral density (vBMD) of the total hip assessed by quantitative computed tomography (QCT)

  Measured in percentage (%).

  From baseline to end of treatment (week 68)

Secondary Outcomes (13)

• Relative changes in vBMD of the lumbar 1 (L1) - L4 vertebrae assessed by QCT

  From baseline to end of treatment (week 68)

• Relative changes in vBMD of the radius assessed by QCT

  From baseline to end of treatment (week 68)

• Relative changes in vBMD of the L1 - L4 vertebrae assessed by QCT

  From baseline to week 20

• Relative changes in vBMD of the radius assessed by QCT

  From baseline to week 20

• Relative change in the Ki (bone turnover) of the femoral neck assessed by fluoride - positron emission tomography (PET)

  From baseline to end of treatment (week 68)

Study Arms (4)

Cagrilintide

EXPERIMENTAL

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.

Drug: Cagrilintide; Drug: Placebo cagrilintide

Semaglutide

EXPERIMENTAL

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.

Drug: Semaglutide; Drug: Placebo semaglutide

CagriSema

EXPERIMENTAL

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.

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo cagrilintide; Drug: Placebo semaglutide

Interventions

Cagrilintide DRUG

Participants will receive once-weekly cagrilintide subcutaneously.

CagriSema; Cagrilintide

Semaglutide DRUG

Participants will receive once-weekly semaglutide subcutaneously.

CagriSema; Semaglutide

Placebo cagrilintide DRUG

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

CagriSema; Cagrilintide; Placebo

Placebo semaglutide DRUG

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

CagriSema; Placebo; Semaglutide

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Steno Diabetes Center Copenhagen

Herlev, 2730, Denmark

RECRUITING

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
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 8, 2025
• Study Start: June 12, 2025
• Primary Completion (Estimated): May 3, 2028
• Study Completion (Estimated): May 3, 2028
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)