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NCT Number: NCT07010432

The Role of the Amylin Analogue Cagrilintide in Bone Metabolism

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Steno Diabetes Center Copenhagen

Herlev, 2730, Denmark

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Cagrilintide

Drug

Participants will receive once-weekly cagrilintide subcutaneously.

semaglutide

Drug

Participants will receive once-weekly semaglutide subcutaneously.

Placebo Cagrilintide

Drug

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

Placebo Semaglutide

Drug

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

Primary outcomes

  1. 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

  1. 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 %.

  2. Relative changes in vBMD of the radius assessed by QCT

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

    Measured in %.

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

    Time frame: From baseline to week 20

    Measured in %.

  4. Relative changes in vBMD of the radius assessed by QCT

    Time frame: From baseline to week 20

    Measured in %.

  5. 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 %.

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

    Time frame: From baseline to week 20

    Measured in %.

  7. 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 %.

  8. Relative changes in CTX-1 and P1NP

    Time frame: From baseline to week 20

    Measured in %.

  9. 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 %.

  10. Relative changes in trabecular thickness assessed by PCCT

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

    Measured in %.

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

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

    Measured in %.

  12. Relative changes in L1-L2 vertebrae assessed by PCCT

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

    Measured in %.

  13. Relative changes in radius assessed by PCCT

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

    Measured in %.

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: RAMBO

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 8, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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