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 — DRUGParticipants will receive 2.4 mg cagrilintide subcutaneously.
- Semaglutide — DRUGParticipants will receive 2.4 mg semaglutide subcutaneously.
- Placebo Semaglutide — DRUGParticipants will receive placebo matched to semaglutide subcutaneously.
- Placebo Cagrilintide — DRUGParticipants 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: CagriSemaParticipants will receive once-weekly subcutaneous (s.c) injections of 2.4 mg cagrilintide and 2.4 mg semaglutide for 44 weeks.
- Active Comparator: SemaglutideParticipants will receive once-weekly s.c injection of 2.4 mg semaglutide for 44 weeks.
- Placebo Comparator: PlaceboParticipants 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) ]
Related Studies
- Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b StudyPHASE3 · Recruiting · Eli Lilly and Company · Dothan, Alabama
- Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or OverweightPHASE3 · Recruiting · Eli Lilly and Company · Dothan, Alabama
- A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 DiabetesPHASE3 · Recruiting · Hoffmann-La Roche · Anniston, Alabama
- A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 DiabetesPHASE3 · Recruiting · Hoffmann-La Roche · Guntersville, Alabama