A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight
Part of paid clinical trials in Concord, California.
- Sponsor
- Novo Nordisk A/S
- Study ID
- NCT05394519
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Cagrilintide — DRUGCagrilintide administered subcutaneously (s.c., under the skin) once-weekly
- Semaglutide — DRUGSemaglutide administered subcutaneously (s.c., under the skin) once-weekly
- Placebo cagrilintide — DRUGPlacebo cagrilintide administered subcutaneously (s.c., under the skin) once-weekly
- Placebo semaglutide — DRUGPlacebo semaglutide administered subcutaneously (s.c., under the skin) once-weekly
Study Details
This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. Which treatment they get is decided by chance. The study will last for about 1½ years. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.
Key Dates
- Start date
- Feb 1, 2023
- Status verified
- Jan 2026
- Primary completion
- Jan 28, 2025
- Completion
- Feb 3, 2025
Study Design
- Enrollment
- 1,200 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: CagriSemaCagrilintide + semaglutide once weekly
- Placebo Comparator: PlaceboPlacebo cagrilintide + semaglutide once weekly
Primary Outcome Measure
Relative change in body weight [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
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