Not Yet RecruitingPhase 2/3

Semaglutide for the Prevention Of Post-Transplant Diabetes Mellitus

Canada74 participantsStarted 2026-01-05

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Signed and dated written informed consent.
✓. Adult (≥18 years) recipients of a living or deceased donor kidney transplant
✓. Between 4- and 12-weeks post kidney transplant
✓. Stable kidney function defined as an eGFR \> 30 ml/min/1.73m2 (CKD-EPI)
✓. At risk for PTDM at the time of transplant based on the following criteria:
✓. BMI ≥ 25 kg/m2, or
✓. Fasting plasma glucose 6.1-6.9 mmol/L (impaired fasting glucose), or
✓. 2hr OGTT plasma glucose 7.8-11.0 (impaired glucose tolerance), or

Exclusion criteria

✕. Established diagnosis of type 1 or type 2 DM as per Diabetes Canada (including the need for glucose-lowering therapy for hyperglycemia at the time of screening)
✕. Kidney-Pancreas transplant recipient
✕. Acute coronary syndrome, transient ischemic attack or stroke within 30 days prior to screening
✕. History of pancreatitis
✕. Personal or family history of medullary thyroid cancer or MEN2B
✕. Women who are pregnant, nursing or plan on becoming pregnant whilst in the trial
✕. Use of GLP1RA in the 30 days prior to screening
✕. Contraindication to MRI (applicable only to those undergoing the optional MRI assessments)

What they're measuring

2-hour OGTT

Timeframe: 24 weeks

Trial details

NCT IDNCT06913023

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-11-30

Contact for this trial

Vesta Lai

416-340-4800 vesta.lai@uhn.ca

View on ClinicalTrials.gov More Kidney Transplant Recipient trials