A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose Weight

Sponsor
Novo Nordisk A/S
Study ID
NCT05996848
Phase
PHASE3
Status
Completed

Conditions

  • Obesity or Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cagrilintide — DRUG
    Participants will receive 2.4 mg cagrilintide subcutaneously.
  • Semaglutide — DRUG
    Participants will receive 2.4 mg semaglutide subcutaneously.
  • Placebo Semaglutide — DRUG
    Participants will receive placebo matched to semaglutide subcutaneously.
  • Placebo Cagrilintide — DRUG
    Participants will receive placebo matched to cagrilintide subcutaneously.

Study Details

This study will look at how well the new medicine CagriSema helps people with excess body weight losing weight compared to a "dummy" medicine and a medicine called semaglutide. Participants will either get CagriSema, a dummy medicine or semaglutide. Which treatment participants get is decided by chance. Participants will take one injection once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for about 1 year.

Key Dates

Start date
Aug 15, 2023
Status verified
Jan 2026
Primary completion
Jan 6, 2025
Completion
Feb 22, 2025

Study Design

Enrollment
300 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CagriSema
    Participants will receive once-weekly subcutaneous (s.c) injections of 2.4 mg cagrilintide and 2.4 mg semaglutide for 44 weeks.
  • Active Comparator: Semaglutide
    Participants will receive once-weekly s.c injection of 2.4 mg semaglutide for 44 weeks.
  • Placebo Comparator: Placebo
    Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 44 weeks.

Primary Outcome Measure

CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight [ Time Frame: From baseline (week 0) to end of treatment (week 44) ]

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