DRUG
Cagrilintide
Participants will receive once-weekly cagrilintide subcutaneously.
The Role of the Amylin Analogue Cagrilintide in Bone Metabolism
Status
Recruiting
Phase
Phase 1
Enrollment
144
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Semaglutide
Participants will receive once-weekly semaglutide subcutaneously.
DRUG
Placebo cagrilintide
Participants will receive once-weekly placebo matched to cagrilintide subcutaneously.
DRUG
Placebo semaglutide
Participants will receive once-weekly placebo matched to semaglutide subcutaneously.
Timeline
From registration to results.
First posted
Jun 8, 2025
Study start
Jun 12, 2025
Primary completion
May 3, 2028
Study completion
May 3, 2028
Results posted
Not reported
Registry updated
Jul 25, 2025
Outcomes
What the study measures.
Primary outcomes
Relative change in volumetric bone mineral density (vBMD) of the total hip assessed by quantitative computed tomography (QCT)
Time frame · From baseline to end of treatment (week 68)
Measured in percentage (%).
Secondary outcomes
Relative changes in vBMD of the lumbar 1 (L1) - L4 vertebrae assessed by QCT
Time frame · From baseline to end of treatment (week 68)
Measured in %.
Relative changes in vBMD of the radius assessed by QCT
Time frame · From baseline to end of treatment (week 68)
Measured in %.
Relative changes in vBMD of the L1 - L4 vertebrae assessed by QCT
Time frame · From baseline to week 20
Measured in %.
Relative changes in vBMD of the radius assessed by QCT
Time frame · 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)
Time frame · 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
Time frame · 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)
Time frame · From baseline to end of treatment (week 68)
Measured in %.
Relative changes in CTX-1 and P1NP
Time frame · From baseline to week 20
Measured in %.
Relative changes in cortical thickness and porosity assessed by photon-counting computed tomography (PCCT)
Time frame · From baseline to end of treatment (week 68)
Measured in %.
Relative changes in trabecular thickness assessed by PCCT
Time frame · From baseline to end of treatment (week 68)
Measured in %.
Eligibility
Who can take part.
- Minimum age
- 50 Years
- Maximum age
- 70 Years
- Sex
- FEMALE
- Healthy volunteers
- No
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).
Study locations
1 registered sites.
Denmark. Showing up to 24 locations stored in the fast local snapshot.
Steno Diabetes Center Copenhagen
Herlev, Denmark
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Cagrilintide.
NCT IDStudyPhase / statusEnrollmentUpdated
A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight
Novo Nordisk · Obesity · Type 2 Diabetes
Phase 3
Recruiting
2,500
2026-07
A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term
Novo Nordisk · Obesity
Phase 3
Active, not recruiting
609
2026-07
A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight
Novo Nordisk · Obesity
Phase 3
Active, not recruiting
3,400
2026-07
REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels
Novo Nordisk · Cardiovascular Disease
Phase 3
Active, not recruiting
7,101
2026-07
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both
Novo Nordisk · Diabetes Mellitus, Type 2
Phase 3
Completed
1,023
2026-07
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
Novo Nordisk · Overweight · Obesity
Phase 3
Recruiting
460
2026-07
A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes
Novo Nordisk · Diabetes Mellitus, Type 2
Phase 2
Withdrawn
0
2026-07
A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight
Novo Nordisk · Overweight · Obesity
Phase 3
Withdrawn
0
2026-07
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.