A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both
Part of paid clinical trials in Pelham, Alabama.
- Sponsor
- Novo Nordisk A/S
- Study ID
- NCT06534411
- Phase
- PHASE3
- Status
- Active Not Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Cagrilintide — DRUGParticipants will receive once-weekly cagrilintide subcutaneously.
- Semaglutide — DRUGParticipants will receive once-weekly semaglutide subcutaneously.
- Tirzepatide — DRUGParticipants will receive once-weekly tirzepatide subcutaneously.
Study Details
This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months.
Key Dates
- Start date
- Nov 5, 2024
- Status verified
- Jun 2026
- Primary completion
- Jun 2, 2026
- Completion
- Jul 14, 2026
Study Design
- Enrollment
- 1,023 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: CagriSemaParticipants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every 4 weeks in a 8-week dose escalation period until target dose of CagriSema is achieved and maintained for 52 weeks.
- Experimental: TirzepatideParticipants will receive once-weekly s.c injections of tirzepatide at escalating dose in a 4-week dose escalating period and maintained up to 56 weeks.
Primary Outcome Measure
Change in Glycated Haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to end of treatment (week 60) ]
Locations (54)
Related coverage on Hipa.ai
- CagriSema Phase 3 Trial for Type 2 Diabetes Reaches Primary CompletionCagriSema (Cagrilintide B and Semaglutide I) · Jun 2, 2026 · ClinicalTrials.gov
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