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Recruiting NCT07010432

The Role of the Amylin Analogue Cagrilintide in Bone Metabolism

Phase I Interventional Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cagrilintide, Semaglutide, Placebo cagrilintide, Placebo semaglutide.
Who it may be relevant to
Registry conditions: Obesity. Basic parameters: 50 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Drug Cagrilintide
    Participants will receive once-weekly cagrilintide subcutaneously.
  • 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.

Primary outcome measures

  • 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)]
Secondary outcome measures (12)
  • Relative changes in vBMD of the lumbar 1 (L1) - L4 vertebrae assessed by QCT [Time frame: From baseline to end of treatment (week 68)]
  • Relative changes in vBMD of the radius assessed by QCT [Time frame: From baseline to end of treatment (week 68)]
  • Relative changes in vBMD of the L1 - L4 vertebrae assessed by QCT [Time frame: From baseline to week 20]
  • Relative changes in vBMD of the radius assessed by QCT [Time frame: From baseline to week 20]
  • 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)]
  • Relative change in the Ki (bone turnover) of the femoral neck assessed by fluoride - PET [Time frame: From baseline to week 20]
  • 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)]
  • Relative changes in CTX-1 and P1NP [Time frame: From baseline to week 20]
  • Relative changes in cortical thickness and porosity assessed by photon-counting computed tomography (PCCT) [Time frame: From baseline to end of treatment (week 68)]
  • Relative changes in trabecular thickness assessed by PCCT [Time frame: From baseline to end of treatment (week 68)]
  • Relative changes in number and separation of the femoral neck assessed by PCCT [Time frame: From baseline to end of treatment (week 68)]
  • Relative changes in L1-L2 vertebrae assessed by PCCT [Time frame: From baseline to end of treatment (week 68)]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Steno Diabetes Center Copenhagen — Herlev

Identifiers

NCT: NCT07010432 · NN9388-8175 · U1111-1313-0864 · 2024-517883-49

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗