The Role of the Amylin Analogue Cagrilintide in Bone Metabolism

Sponsor
Novo Nordisk A/S
Study ID
NCT07010432
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
50 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 12, 2025
Status verified
Jul 2025
Primary completion
May 3, 2028
Completion
May 3, 2028

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cagrilintide
    Participants will receive once-weekly subcutaneous (s.c) injections of cagrilintide or placebo at stepwise doses every 4 weeks in a 16-week dose escalation period until target dose is achieved and maintained for 52 weeks as adjunct to a reduced calorie diet.
  • Experimental: Semaglutide
    Participants will receive once-weekly s.c injections of semaglutide or placebo at stepwise doses every 4 weeks in a 16 week dose escalation period until target dose is achieved and maintained for 52 weeks as adjunct to a reduced calorie diet.
  • Experimental: CagriSema
    Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) or placebo at stepwise doses every 4 weeks in a 16 week dose escalation period until target dose is achieved and maintained for 52 weeks as adjunct to a reduced calorie diet.
  • Placebo Comparator: Placebo
    Participants will receive once-weekly s.c injection of placebo matched to semaglutide and cagrilintide for 68 weeks.

Primary Outcome Measure

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) ]

Central Contacts

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