Clinical trial NCT07010432: The Role of the Amylin Analogue Cagrilintide in Bone Metabolism
Official title: The Role of the Amylin Analogue Cagrilintide in Bone Metabolism During Weight Loss in Postmenopausal Women With Obesity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2025-06-08
Enrollment: 144
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Relative change in volumetric bone mineral density (vBMD) of the total hip assessed by quantitative computed tomography (QCT)
timeFrame: From baseline to end of treatment (week 68)
Secondary outcomes:
measure: Relative changes in vBMD of the lumbar 1 (L1) - L4 vertebrae assessed by QCT
timeFrame: From baseline to end of treatment (week 68)
measure: Relative changes in vBMD of the radius assessed by QCT
timeFrame: From baseline to end of treatment (week 68)
measure: Relative changes in vBMD of the L1 - L4 vertebrae assessed by QCT
timeFrame: From baseline to week 20
measure: Relative changes in vBMD of the radius assessed by QCT
timeFrame: From baseline to week 20
measure: Relative change in the Ki (bone turnover) of the femoral neck assessed by fluoride - positron emission tomography (PET)
timeFrame: From baseline to end of treatment (week 68)
measure: Relative change in the Ki (bone turnover) of the femoral neck assessed by fluoride - PET
timeFrame: From baseline to week 20
measure: Relative changes in C-terminal telopeptide of type I collagen (CTX-1) and procollagen type 1 N-terminal propeptide (P1NP)
timeFrame: From baseline to end of treatment (week 68)
measure: Relative changes in CTX-1 and P1NP
timeFrame: From baseline to week 20
measure: Relative changes in cortical thickness and porosity assessed by photon-counting computed tomography (PCCT)
timeFrame: From baseline to end of treatment (week 68)
measure: Relative changes in trabecular thickness assessed by PCCT
timeFrame: From baseline to end of treatment (week 68)
measure: Relative changes in number and separation of the femoral neck assessed by PCCT
timeFrame: From baseline to end of treatment (week 68)
measure: Relative changes in L1-L2 vertebrae assessed by PCCT
timeFrame: From baseline to end of treatment (week 68)
measure: Relative changes in radius assessed by PCCT
timeFrame: From baseline to end of treatment (week 68)
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Steno Diabetes Center Copenhagen
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: