NCT06913023

Semaglutide for the Prevention Of Post-Transplant Diabetes Mellitus

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

A kidney transplant is the best treatment for people living with kidney failure as it allows people to live longer with a better quality of life. However, one in four kidney transplant recipients will develop diabetes after transplant. This is largely due to the medications that must be used to prevent rejection of the transplant. Kidney transplant recipients who get diabetes after transplant are up to three times more likely to have heart disease and die prematurely. To date, there are no treatments to prevent the development of diabetes after kidney transplant. Semaglutide is a drug that is commonly used to treat diabetes and obesity. The investigators believe that semaglutide is a safe and effective drug which can prevent the development of diabetes in kidney transplant recipients. Therefore, the investigators are conducting a study where kidney transplant recipients who are at increased risk of developing diabetes after transplant are randomly assigned to receive either semaglutide or placebo for 24 weeks after their transplant. The study will determine whether semaglutide is effective in decreasing blood sugar levels and the rate of diabetes. The investigators will also study other important markers of health including body weight and cholesterol levels as well as liver, kidney and heart function. Diabetes after transplant is a common problem, and preventing it is extremely important to allowing kidney transplant recipients to live longer and better lives. The results of this study will allow the investigators to determine if semaglutide is a safe and effective option for the prevention of diabetes in kidney transplant recipients.

Conditions

• Kidney Transplant Recipient

Interventions

Type	Name	Description
DRUG	Semaglutide 3 MG [Rybelsus]	Semaglutide 3mg for 4 weeks.
DRUG	Semaglutide 7 MG [Rybelsus]	Semaglutide 7mg for 4 weeks.
DRUG	Semaglutide 14 MG [Rybelsus]	Semaglutide 14mg for 16 weeks.
DRUG	Placebo Oral Tablet	Placebo tablet

Timeline

• Start date: 2026-01-05
• Primary completion: 2027-11-30
• Completion: 2027-11-30
• First posted: 2025-04-06
• Last updated: 2025-04-06

Locations

2 sites across 1 country: Canada