The Role of the Amylin Analogue Cagrilintide in Bone Metabolism

Phase 1

Not yet recruiting

• Conditions: Obesity
• Interventions: Drug: Cagrilintide; Drug: Semaglutide; Drug: Placebo cagrilintide; Drug: Placebo semaglutide

• Registration Number: NCT07010432
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-30
• Study First Submitted QC: 2025-05-30
• Last Update Submitted: 2025-05-30
• Study Start: 2025-06-02
• Study First Posted: 2025-06-08
• Last Update Posted: 2025-06-08
• Primary Completion: 2028-05-03
• Study Completion: 2028-05-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 144

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cagrilintide	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.
Cagrilintide	Placebo 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.
Semaglutide	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.
Semaglutide	Placebo 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.
CagriSema	Cagrilintide	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.
CagriSema	Semaglutide	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.
CagriSema	Placebo cagrilintide	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.
CagriSema	Placebo semaglutide	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.
Placebo	Placebo cagrilintide	Participants will receive once-weekly s.c injection of placebo matched to semaglutide and cagrilintide for 68 weeks.
Placebo	Placebo semaglutide	Participants will receive once-weekly s.c injection of placebo matched to semaglutide and cagrilintide for 68 weeks.

Primary Outcome Measures

Name	Time	Method
Relative change in volumetric bone mineral density (vBMD) of the total hip assessed by quantitative computed tomography (QCT)	From baseline to end of treatment (week 68)	Measured in percentage (%).

Secondary Outcome Measures

Name	Time	Method
Relative changes in vBMD of the lumbar 1 (L1) - L4 vertebrae assessed by QCT	From baseline to end of treatment (week 68)	Measured in %.
Relative changes in vBMD of the radius assessed by QCT	From baseline to week 20	Measured in %.
Relative changes in vBMD of the L1 - L4 vertebrae assessed by QCT	From baseline to week 20	Measured in %.
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)	Measured in %.
Relative change in the Ki (bone turnover) of the femoral neck assessed by fluoride - PET	From baseline to week 20	Measured in %.
Relative changes in C-terminal telopeptide of type I collagen (CTX-1) and procollagen type 1 N-terminal propeptide (P1NP)	From baseline to end of treatment (week 68)	Measured in %.
Relative changes in CTX-1 and P1NP	From baseline to week 20	Measured in %.
Relative changes in cortical thickness and porosity assessed by photon-counting computed tomography (PCCT)	From baseline to end of treatment (week 68)	Measured in %.
Relative changes in trabecular thickness assessed by PCCT	From baseline to end of treatment (week 68)	Measured in %.
Relative changes in number and separation of the femoral neck assessed by PCCT	From baseline to end of treatment (week 68)	Measured in %.
Relative changes in L1-L2 vertebrae assessed by PCCT	From baseline to end of treatment (week 68)	Measured in %.
Relative changes in radius assessed by PCCT	From baseline to end of treatment (week 68)	Measured in %.

Trial Locations

Locations (1)

Steno Diabetes Center Copenhagen; 🇩🇰 Herlev, Denmark