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RAMBO

RecruitingPhase 1

The Role of the Amylin Analogue Cagrilintide in Bone Metabolism

The Role of the Amylin Analogue Cagrilintide in Bone Metabolism During Weight Loss in Postmenopausal Women With Obesity

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide

Listed sites

Recruiting sites

Enrollment

144

estimated

Study population

Obesity / overweight

Key I/E criteria

•BMI ≥30•Female

Primary endpoint

•Volumetric bone mineral density (vBMD) of the total hip

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07010432

Org study IDNN9388-8175

Secondary ID2024-517883-49European Medical Agency (EMA)

Secondary IDU1111-1313-0864World Health Organization (WHO)

Timeline

Milestones

Study first posted2025-06-08actual

Study start2025-06-12actual

Last update posted2025-07-25actual

Primary completion2028-05-03estimated

Study completion2028-05-03estimated

Assets

Investigational agents

CagriSema / cagrilintide Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age50 Years

Maximum age70 Years

SexFemale

Healthy volunteersNot accepted

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).

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Weight & body composition

Other (unclassified)

Weight & body composition

5 endpoints

Primary/protocol endpoint

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)

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:From baseline to week 20

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Relative changes in vBMD of the radius assessed by QCT

Time frame:From baseline to week 20

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Relative changes in trabecular thickness assessed by PCCT

Time frame:From baseline to end of treatment (week 68)

percent change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Relative changes in L1-L2 vertebrae assessed by PCCT

Time frame:From baseline to end of treatment (week 68)

percent change from baseline, improvement

Other clinical outcomes

6 endpoints

Secondary/protocol endpoint

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

Time frame:From baseline to end of treatment (week 68)

percent change from baseline, improvement

Secondary/protocol endpoint

Relative changes in vBMD of the radius assessed by QCT

Time frame:From baseline to end of treatment (week 68)

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

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)

percent change from baseline, descriptive

Secondary/protocol endpoint/low confidence

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

Time frame:From baseline to week 20

percent change from baseline, improvement

Secondary/protocol endpoint

Relative changes in cortical thickness and porosity assessed by photon-counting computed tomography (PCCT)

Time frame:From baseline to end of treatment (week 68)

percent change from baseline, descriptive

Secondary/protocol endpoint

Relative changes in number and separation of the femoral neck assessed by PCCT

Time frame:From baseline to end of treatment (week 68)

percent change from baseline, descriptive

Other (unclassified)

3 endpoints

Secondary/protocol endpoint/low confidence

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)

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Relative changes in CTX-1 and P1NP

Time frame:From baseline to week 20

percent change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Relative changes in radius assessed by PCCT

Time frame:From baseline to end of treatment (week 68)

percent change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.