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SPOT-DM

Not yet recruitingPhase 2, PHASE3

Semaglutide for the Prevention Of Post-Transplant Diabetes Mellitus

Asset

Semaglutide

GLP-1 agonist

Listed sites

2

Recruiting sites

Enrollment

74

estimated

Study population

Key I/E criteria

BMI ≥25HbA1c 5.5-6.4%eGFR ≥30

Primary endpoint

Postprandial glucose

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06913023
Org study ID25-5093

Timeline

Milestones

Study first posted2025-04-06actual
Last update posted2025-04-06actual
Study start2026-01-05estimated
Primary completion2027-11-30estimated
Study completion2027-11-30estimated

Assets

Investigational agents

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (23)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
5
Renal / kidney
5
Weight & body composition
4
Cardiometabolic biomarkers
4
MASH / liver
3
Safety / tolerability / PK
1
Other (unclassified)
1

Weight & body composition

4 endpoints
Secondary/protocol endpoint

Percentage of body fat

Time frame:24 weeks

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:24 weeks

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in body weight

Time frame:24 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of extracellular fluid

Time frame:24 weeks

descriptive

Glycemic / diabetes

5 endpoints
Primary/protocol endpoint

2-hour OGTT

Time frame:24 weeks

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in fasting blood glucose

Time frame:24 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

Urinary glucose excretion

Time frame:24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Change in serum insulin

Time frame:24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in HbA1c

Time frame:24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

3 endpoints
Secondary/protocol endpoint/low confidence

Change in liver enzymes

Time frame:24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in fibrosis level

Time frame:24 weeks

Liver stiffness (VCTE), change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in steatosis level

Time frame:24 weeks

change from baseline, improvement

Renal / kidney

5 endpoints
Secondary/protocol endpoint

Estimated GFR

Time frame:24 weeks

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

GFR

Time frame:24 weeks

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Albuminuria

Time frame:24 weeks

uACR, change

change from baseline, improvement

LOINC 9318-7

Other/protocol endpoint

Change in kidney oxygenation (R2*)

Time frame:24 weeks

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in kidney fibrosis (ADC)

Time frame:24 weeks

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

Change in fasting lipid profile

Time frame:24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Systolic blood pressure

Time frame:24 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Diastolic blood pressure

Time frame:24 weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Mean arterial pressure

Time frame:24 weeks

Mean arterial pressure

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Time frame:24 weeks

Treatment-emergent AEs (any)

event count, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Natriuresis

Time frame:24 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.