Semaglutide for the Prevention Of Post-Transplant Diabetes Mellitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-05

Study Completion Date

2027-11-30

Brief Summary

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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).

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Detailed Description

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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

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Kidney Transplant Recipient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will use a randomized, double-blind, placebo-controlled clinical trial approach comparing semaglutide to placebo in 50 KTR at risk for PTDM. Adult KTR between 4 and 12 weeks after transplant with an eGFR of at least 30 ml/min/1.73m2 at risk for PTDM will be randomized in a 1:1 fashion to either 24 weeks of semaglutide or 24 weeks of placebo.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Semaglutide

Patients 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.

Group Type EXPERIMENTAL

Semaglutide 3 MG [Rybelsus]

Intervention Type DRUG

Semaglutide 3mg for 4 weeks.

Semaglutide 7 MG [Rybelsus]

Intervention Type DRUG

Semaglutide 7mg for 4 weeks.

Semaglutide 14 MG [Rybelsus]

Intervention Type DRUG

Semaglutide 14mg for 16 weeks.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Placebo tablet

Interventions

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Semaglutide 3 MG [Rybelsus]

Semaglutide 3mg for 4 weeks.

Intervention Type DRUG

Semaglutide 7 MG [Rybelsus]

Semaglutide 7mg for 4 weeks.

Intervention Type DRUG

Semaglutide 14 MG [Rybelsus]

Semaglutide 14mg for 16 weeks.

Intervention Type DRUG

Placebo Oral Tablet

Placebo tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Signed and dated written informed consent.
2. Adult (≥18 years) recipients of a living or deceased donor kidney transplant
3. Between 4- and 12-weeks post kidney transplant
4. Stable kidney function defined as an eGFR \> 30 ml/min/1.73m2 (CKD-EPI)
5. At risk for PTDM at the time of transplant based on the following criteria:

1. BMI ≥ 25 kg/m2, or
2. Fasting plasma glucose 6.1-6.9 mmol/L (impaired fasting glucose), or
3. 2hr OGTT plasma glucose 7.8-11.0 (impaired glucose tolerance), or
4. HbA1C 5.5-6.4% (at risk for DM or prediabetes).

Exclusion Criteria

1. 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)
2. Kidney-Pancreas transplant recipient
3. Acute coronary syndrome, transient ischemic attack or stroke within 30 days prior to screening
4. History of pancreatitis
5. Personal or family history of medullary thyroid cancer or MEN2B
6. Women who are pregnant, nursing or plan on becoming pregnant whilst in the trial
7. Use of GLP1RA in the 30 days prior to screening
8. Contraindication to MRI (applicable only to those undergoing the optional MRI assessments)
9. With known or suspected hypersensitivity to semaglutide or related products
10. Patient not able to understand and comply with study requirements, based on Investigator's judgment.
11. Any other clinical condition that, based on Investigator's judgement, would jeopardize patient safety during trial participation or would affect the study outcom
12. History of glucose-galactose malabsorption syndrome

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No