Semaglutide for the Prevention Of Post-Transplant Diabetes Mellitus
- Sponsor
- University Health Network, Toronto
- Study ID
- NCT06913023
- Phase
- PHASE2/PHASE3
- Status
- Not Yet Recruiting
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Conditions
- Kidney Transplant Recipient
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Semaglutide 3 MG [Rybelsus] — DRUGSemaglutide 3mg for 4 weeks.
- Semaglutide 7 MG [Rybelsus] — DRUGSemaglutide 7mg for 4 weeks.
- Semaglutide 14 MG [Rybelsus] — DRUGSemaglutide 14mg for 16 weeks.
- Placebo Oral Tablet — DRUGPlacebo tablet
Study Details
The study aims to determine the short-term efficacy, mechanisms and safety of 24 weeks of placebo and semaglutide therapy in 74 KTR at risk of post-transplant diabetes mellitus (PTDM).
Key Dates
- Start date
- Jan 5, 2026
- Status verified
- Apr 2025
- Primary completion
- Nov 30, 2027
- Completion
- Nov 30, 2027
Study Design
- Enrollment
- 74 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: SemaglutidePatients will be up-titrated as tolerated starting at 3 mg oral semaglutide once daily for 4 weeks, followed by 7 mg oral semaglutide once daily for 4 weeks and then 14 mg oral semaglutide once daily for 16 weeks. Semaglutide can be down-titrated to previously tolerated dose if the current dose is not tolerated by the participant.
- Placebo Comparator: Placebo
Primary Outcome Measure
2-hour OGTT [ Time Frame: 24 weeks ]
Central Contacts
- Vesta Lai416-340-4800