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

Sponsor
Novo Nordisk A/S
Study ID
NCT05813925
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 s.c. OW after a dose escalation period of 16 weeks for 52 weeks
  • Semaglutide — DRUG
    Participants will receive 2.4 mg semaglutide s.c. OW after a dose escalation period of 16 weeks for 52 weeks
  • Placebo Semaglutide — DRUG
    Participants will receive placebo matched to semaglutide

Study Details

This study will look at how well the new medicine CagriSema helps people with excess body weight lose weight compared to another medicine, semaglutide. The participants will receive one injection once a week. The study medicine will be injected with a thin needle, typically in the stomach, thighs or upper arms. The study will last for about 1½ years.

Key Dates

Start date
Apr 3, 2023
Status verified
Jan 2026
Primary completion
Jan 17, 2025
Completion
Mar 7, 2025

Study Design

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

Arms

  • Experimental: CagriSema 2.4 mg/2.4 mg
    Participants will receive 2.4 milligrams (mg) cagrilintide and 2.4 mg semaglutide subcutaneously (s.c.) once-weekly (OW) after a dose escalation period of 16 weeks (0.25 mg of cagrilintide and 0.25 mg of semaglutide from weeks 0-4, 0.5 mg of cagrilintide and 0.5 mg of semaglutide from weeks 5-8, 1 mg of cagrilintide and 1 mg of semaglutide from weeks 9-12 and 1.7 mg of cagrilintide and 1.7 mg of semaglutide from weeks 13-16) during the maintenance period for 52 weeks
  • Active Comparator: Semaglutide 2.4 mg
    Participants will receive semaglutide s.c. 2.4 mg and placebo matched to semaglutide OW after a dose escalation period of 16 weeks (0.25 mg for weeks 0-4, 0.5 mg for weeks 5-8, 1 mg for weeks 9-12 and 1.7 mg for weeks 13-16) during the maintenance period for 52 weeks

Primary Outcome Measure

Relative Change in Body Weight [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]

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