A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Novo Nordisk A/S
- Study ID
- NCT07357766
- Phase
- PHASE3
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Cagrisema — DRUGCagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously using device 1 or device 2.
- Placebo CagriSema — DRUGPlacebo matched to Cagrilintide and Placebo matched to Semaglutide will be administered subcutaneously using device 1 or device 2.
Study Details
This study is being done to find out how well a medicine called CagriSema helps people with overweight or obesity lose weight. CagriSema is still being tested in studies and is not yet available for doctors to prescribe. In this study the sponsor will compare two version of CagriSema injected by two different types of injection devices. Which treatment participants get is decided by chance using a computer program, so neither participants nor study staff will know which treatment is given. The study will last for about one year.
Key Dates
- Start date
- Jun 22, 2026
- Status verified
- Feb 2026
- Primary completion
- Nov 29, 2027
- Completion
- Jan 17, 2028
Study Design
- Enrollment
- 1,400 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: CagriSema B in device 2 + Placebo in device 1Participants will receive CagriSema B in device 2 followed by placebo matched to CagriSema in device 1 subcutaneously once weekly in a dose escalation manner for 16 weeks until the target maintenance dose and further continue to receive the same dose for up to 44 weeks.
- Experimental: CagriSema in device 1 + Placebo in device 2Participants will receive CagriSema in device 1 followed by placebo matched to CagriSema B in device 2 subcutaneously once weekly in a dose escalation manner for 16 weeks until the target maintenance dose and further continue to receive the same dose for up to 44 weeks.
- Placebo Comparator: Placebo in device 1 + Placebo in device 2Participants will receive placebo matched to Cagrisema in device 1 followed by placebo matched to CagriSema B in device 2 subcutaneously once weekly for up to 44 weeks.
Primary Outcome Measure
Relative change in body weight [ Time Frame: From baseline (week 0) to end of treatment (week 44) ]
Central Contacts
- Novo Nordisk(+1) 866-867-7178
Locations (26)
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