Kidney Transplant RecipientPhase 2/3SPOT-DMNCT06913023
Semaglutide for the Prevention Of Post-Transplant Diabetes Mellitus
A Phase 2/3 study testing Semaglutide 0.25 mg, Semaglutide 0.5 mg and Semaglutide 1.0 mg in people with Kidney Transplant Recipient, run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
The study aims to determine the short-term efficacy, mechanisms and safety of 24 weeks of semaglutide therapy in 37 KTR at risk of post-transplant diabetes mellitus (PTDM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Recipient
- What is being tested?
- Semaglutide 0.25 mg, Semaglutide 0.5 mg and Semaglutide 1.0 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesCanada
- Study dates
- 5 Dec 2026to 30 Dec 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- HbA1C 5.5-6.4% (at risk for DM or prediabetes).
Who cannot join
- 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
Show all 12Show fewer
- Use of GLP1RA in the 30 days prior to screening
- Contraindication to MRI (applicable only to those undergoing the optional MRI assessments)
- With known or suspected hypersensitivity to semaglutide or related products
- Patient not able to understand and comply with study requirements, based on Investigator's judgment.
- Any other clinical condition that, based on Investigator's judgement, would jeopardize patient safety during trial participation or would affect the study outcom
- History of glucose-galactose malabsorption syndrome
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
Toronto General Hospital
Toronto, Ontario, M5G 2N2
Cheng Xu, 416-340-4800 ext. 8508, cheng.xu@uhn.ca
Sunita Singh, MD MSc FRCPC
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Vikas S Srinivasan, MD PhD FRCPC, 604-806-8970, vikas.sridhar@phc.ca
About this study
The study aims to determine the short-term efficacy, mechanisms and safety of 24 weeks of semaglutide therapy in 37 KTR at risk of post-transplant diabetes mellitus (PTDM).
Read the 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 will receive semaglutide 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
- Being tested
- Semaglutide 0.25 mg, Semaglutide 0.5 mg, Semaglutide 1.0 mg, Semaglutide 1.7mg subcutaneous, Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide 0.25 mgDrug
Subcutaneous semaglutide 0.25mg for 4 weeks.
Semaglutide 0.5 mgDrug
Subcutaneous semaglutide 0.5mg for 4 weeks.
Semaglutide 1.0 mgDrug
Subcutaneous semaglutide 1.0 mg for 4 weeks.
Semaglutide 1.7mg subcutaneousDrug
Subcutaneous semaglutide 1.7 mg for 4 weeks
Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY]Drug
Subcutaneous semaglutide 2.4 mg for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Patients will be up-titrated as tolerated starting at 0.25 mg subcutaneous semaglutide once weekly for 4 weeks, followed by 0.5 mg, 1.0 mg, and 1.7 mg semaglutide for 4 weeks each, and then 2.4 mg subcutaneous semaglutide once weekly for 8 weeks. Semaglutide can be down-titrated by the investigator to lower doses or up-titrated at slower rates if not tolerated by the participant. Receives: Drug: Semaglutide 0.25 mg; Drug: Semaglutide 0.5 mg; Drug: Semaglutide 1.0 mg; Drug: Semaglutide 1.7mg subcutaneous; Drug: Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY] |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-hour OGTT
The primary outcome of this study is the change in plasma glucose at 120 minutes following a 75g oral glucose challenge (2-hour OGTT) at 24 weeks. The 2-hour OGTT was selected as the primarily outcome in this study for the following reasons: 1) In selecting a surrogate outcome for PTDM in KTR, there are limitations to HbA1c and fasting glucose in this population; 2) The 2-hour OGTT is the recommended test for the diagnosis of PTDM in KTR and 3) The use of OGTT has been used in other PTDM prevention studies.
Measured: 24 weeks
Secondary outcomes (19)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
: The side effects of GLP-1RA have been well described and will be assessed at each study visit. Adverse events include AKI, hypoglycemia, volume depletion, GI intolerance, amputations, pancreatitis, hepatobiliary complications and injection site or allergic reactions, infectious complications (any source), and malignancy. Episodes of biopsy-proven acute rejection (as defined by the Banff criteria), death-censored graft failure (defined as the need for initiation of chronic dialysis or re-transplantation) or death with graft function (defined as death with a functioning allograft) will also be collected. Kidney transplantation assures complete denervation of the transplanted kidney and the renal vasoconstrictive response in the setting of intravascular volume depletion is diminished in KTR. Therefore, frequent monitoring for adverse events has been integrated in our study design, occurring on 10 separate occasions, to capture these adverse events should they occur.
Measured: 24 weeks
Estimated GFR
Calculated by CKD-EPI 2021 equation
Measured: 24 weeks
Change in fasting blood glucose
Measured: 24 weeks
GFR
Measured using 24-urine collection for creatinine, standardized per 1.73m2 body surface area. And estimated using CKD-EPI 2021 equation.
Measured: 24 weeks
Change in serum insulin
Measured: 24 weeks
Change in HbA1c
Measured: 24 weeks
Albuminuria
measuring urine albumin excretion from a 24-hour urine collection
Measured: 24 weeks
Natriuresis
Assessed with a 24-hour urine collection for sodium excretion
Measured: 24 weeks
Percentage of body fat
Bioimpedance analysis
Measured: 24 weeks
Change in fasting lipid profile
Measured: 24 weeks
Change in liver enzymes
ALT and AST
Measured: 24 weeks
Change in fibrosis level
Transient elastography
Measured: 24 weeks
Change in steatosis level
Transient elastography
Measured: 24 weeks
Change in waist circumference
Measured: 24 weeks
Change in body weight
Measured: 24 weeks
Systolic blood pressure
Measured: 24 weeks
Diastolic blood pressure
Measured: 24 weeks
Mean arterial pressure
Measured: 24 weeks
Percentage of extracellular fluid
Bioimpedance analysis
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start5 Dec 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RecipientStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study will use a open-label single-arm clinical trial approach evaluating semaglutide in 37 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 receive 24 weeks of semaglutide.
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunita Singh, MD, MSc, FRCPC, University Health Network, Toronto
- Investigators
- Sunita Singh, MD MSc FRCPC, Principal investigator, University Health Network, Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913023
- Sponsor's protocol ID
- 25-5093
- Acronym
- SPOT-DM
- Status last verified
- Nov 2026
- First submitted
- 17 Mar 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semaglutide for the Prevention Of Post-Transplant Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06913023
- Acronym / sponsor ID
- SPOT-DM / 25-5093
- Conditions
- Kidney Transplant Recipient
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 5 Dec 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to determine the short-term efficacy, mechanisms and safety of 24 weeks of semaglutide therapy in 37 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 will receive semaglutide 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will use a open-label single-arm clinical trial approach evaluating semaglutide in 37 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 receive 24 weeks of semaglutide.
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: Semaglutide 0.25 mg, Drug: Semaglutide 0.5 mg, Drug: Semaglutide 1.0 mg, Drug: Semaglutide 1.7mg subcutaneous, Drug: Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY]Patients will be up-titrated as tolerated starting at 0.25 mg subcutaneous semaglutide once weekly for 4 weeks, followed by 0.5 mg, 1.0 mg, and 1.7 mg semaglutide for 4 weeks each, and then 2.4 mg subcutaneous semaglutide once weekly for 8 weeks. Semaglutide can be down-titrated by the investigator to lower doses or up-titrated at slower rates if not tolerated by the participant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide 0.25 mgSubcutaneous semaglutide 0.25mg for 4 weeks. | Drug | Semaglutide |
| Semaglutide 0.5 mgSubcutaneous semaglutide 0.5mg for 4 weeks. | Drug | Semaglutide |
| Semaglutide 1.0 mgSubcutaneous semaglutide 1.0 mg for 4 weeks. | Drug | Semaglutide |
| Semaglutide 1.7mg subcutaneousSubcutaneous semaglutide 1.7 mg for 4 weeks | Drug | Semaglutide |
| Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY]Subcutaneous semaglutide 2.4 mg for 8 weeks | Drug | Semaglutide |
Primary outcome
2-hour OGTT
Time frame: 24 weeks
The primary outcome of this study is the change in plasma glucose at 120 minutes following a 75g oral glucose challenge (2-hour OGTT) at 24 weeks. The 2-hour OGTT was selected as the primarily outcome in this study for the following reasons: 1) In selecting a surrogate outcome for PTDM in KTR, there are limitations to HbA1c and fasting glucose in this population; 2) The 2-hour OGTT is the recommended test for the diagnosis of PTDM in KTR and 3) The use of OGTT has been used in other PTDM prevention studies.
19 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 24 weeks
Estimated GFR
Time frame: 24 weeks
Change in fasting blood glucose
Time frame: 24 weeks
GFR
Time frame: 24 weeks
Change in serum insulin
Time frame: 24 weeks
Change in HbA1c
Time frame: 24 weeks
Albuminuria
Time frame: 24 weeks
Natriuresis
Time frame: 24 weeks
Percentage of body fat
Time frame: 24 weeks
Change in fasting lipid profile
Time frame: 24 weeks
Change in liver enzymes
Time frame: 24 weeks
Change in fibrosis level
Time frame: 24 weeks
Change in steatosis level
Time frame: 24 weeks
Change in waist circumference
Time frame: 24 weeks
Change in body weight
Time frame: 24 weeks
Systolic blood pressure
Time frame: 24 weeks
Diastolic blood pressure
Time frame: 24 weeks
Mean arterial pressure
Time frame: 24 weeks
Percentage of extracellular fluid
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sunita Singh, MD MSc FRCPC principal investigator
University Health Network, Toronto General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Semaglutide 0.25 mg, Semaglutide 0.5 mg and Semaglutide 1.0 mg in people with Kidney Transplant Recipient, run by University Health Network, Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cheng Xu (416-340-4800 ext. 8508, cheng.xu@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-hour OGTT (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.