A Research Study to Look at How CagriSema Influences Food Intake, Appetite and Emptying of the Stomach in People With Excess Body Weight
- Sponsor
- Novo Nordisk A/S
- Study ID
- NCT06207877
- Phase
- PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Cagrilintide — DRUGCagrilintide will be administered subcutaneously.
- Semaglutide — DRUGSemaglutide will be administered subcutaneously.
- Placebo — DRUGPlacebo will be administered subcutaneously.
Study Details
This research study tests if CagriSema influences food intake, appetite and emptying of the stomach in people with excess body weight. Participant will either get CagriSema (active medicine) or placebo (a dummy medicine), which has no effect on the body. The treatment participants get is decided by chance. The study will last for about 32 weeks.
Key Dates
- Start date
- Feb 23, 2024
- Status verified
- Jan 2026
- Primary completion
- Oct 16, 2024
- Completion
- Nov 22, 2024
Study Design
- Enrollment
- 62 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: CagriSemaParticipants will receive dose 1 cagrilintide and dose 2 semaglutide subcutaneously once-weekly (dose escalation period of 16 weeks) during the maintenance period of 5 weeks.
- Active Comparator: PlaceboParticipants will receive placebo matched to cagrilintide and semaglutide subcutaneously once-weekly for 21 weeks.
Primary Outcome Measure
Relative change in energy intake during ad libitum lunch, evening meal and snackbox [ Time Frame: Baseline to Day 156 ]
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