DelfaGLP-1 Atlas

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Sema-RTx

RecruitingPhase 4

Semaglutide Treatment for Hyperglycaemia After Renal Transplantation

Safety and Efficacy of Oral Semaglutide in Hyperglycaemic Patients After Renal Transplantation

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

104

estimated

Study population

Diabetes (other / unspecified), Renal impairment, Type 2 diabetes

Key I/E criterion

•eGFR 10-40

Primary endpoint

•Mean sensor glucose (mmol/L)

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 IDNCT05702931
Org study ID2022-501170-20-00

Timeline

Milestones

Study first posted2023-01-27actual
Study start2024-09-19actual
Last update posted2025-12-29actual
Primary completion2027-12estimated (month precision)
Study completion2027-12estimated (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Diabetes (other / unspecified)Renal impairmentType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Written informed consent obtained before any trial-related procedures are performed

2. Male or female; age: 18-80 years

3. Diagnosis of post-transplant hyperglycaemia 10 to 40 days after transplantation: Fasting plasma glucose ≥ 7.0 mmol/L or an oral glucose tolerance test with at plasma glucose ≥ 11.1 mmol/L or Pre-transplant type 2 diabetes: Receiving glucose-lowring treatment prior to kidney transplantation

4. An eGFR > 15 ml/min/1.73 m2 10 to 40 days after renal transplantation

5. Subject must be willing and able to comply with trial protocol

Exclusion criteria

1. Type 1 diabetes

2. Dialysis

3. High risk immunological transplantation (not including ABO-incompatible or re-transplantation)

4. Early graft rejection (all rejections verified by biopsy, except borderline rejections. Study initiations can begin 5 days after last dose of rejection treatment with methylprednisolone)

5. Chronic pancreatitis/previous acute pancreatitis

6. Known or suspected hypersensitivity to trial or related products

7. Use of DPP-4 inhibitors within five days prior to screening

8. Use of GLP-1RA within 10 days prior to screening

9. Malignancy (except basal cell carcinoma)

10. Inflammatory bowel disease

11. Previous bowel resection

12. Cardiac disease defined as decompensated heart failure (New York Heart Association class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last six months

13. Any acute condition or exacerbation of chronic condition that would in the investigator's opinion interfere with the initial trial visit schedule and procedures.

14. Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant, or are not using adequate contraceptive methods

15. Impaired liver function (plasma ALAT > two times upper reference levels)

16. Elevated amylase (plasma amylase > two times upper reference levels)

17. Untreated proliferative diabetic retinopathy, untreated diabetic macular edema or active conditions of this type that are not under therapeutic control according

18. Any condition that clinically significantly impairs the observation of the fundus or anterior chamber

Endpoints (30)

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
11
Safety / tolerability / PK
6
Cardiometabolic biomarkers
5
Renal / kidney
3
Weight & body composition
2
MASH / liver
1
Patient-reported / QoL
1
Other (unclassified)
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Body weight (kg)

Time frame:14 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Body mass index (kg/m2)

Time frame:14 weeks

BMI, change

change from baseline, improvement

Glycemic / diabetes

11 endpoints
Primary/protocol endpoint/low confidence

Mean sensor glucose (mmol/L)

Time frame:14 weeks

change from baseline, improvement

Secondary/protocol endpoint

Percentage time in target range (3.9-10.0 mmol/L)

Time frame:14 weeks

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint

Percentage time in hyperglycaemia (level 1 (10.1-13.9 mmol/L) and level 2 (above 13.9 mmol/L)

Time frame:14 weeks

CGM time-above-range

descriptive, improvement

Secondary/protocol endpoint

Glucose variability (standard deviation [mmol/L] and coefficient of variation [%])

Time frame:14 weeks

descriptive

Secondary/protocol endpoint/low confidence

Glucose management indicator (mmol/mol and %)

Time frame:14 weeks

change from baseline, improvement

Secondary/protocol endpoint

HbA1c (mmol/mol)

Time frame:14 weeks

descriptive

LOINC 4548-4

Secondary/protocol endpoint

HbA1c (%)

Time frame:14 weeks

descriptive

LOINC 4548-4

Secondary/protocol endpoint

Daily insulin dose (IE per day)

Time frame:14 weeks

change from baseline, improvement

Secondary/protocol endpoint

Plasma insulin (pmol/L)

Time frame:14 weeks

concentration, descriptive

Secondary/protocol endpoint

C-peptide (nmol/L)

Time frame:14 weeks

concentration, descriptive

Secondary/protocol endpoint

Homeostatic model assessment (HOMA) for assessing beta-cell function and insulin 192 resistance

Time frame:14 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

MASH / liver

1 endpoint
Secondary/protocol endpoint

Plasma alanine transaminase (ALAT) (U/L)

Time frame:14 weeks

ALT, change

change from baseline, improvement

LOINC 1742-6

Renal / kidney

3 endpoints
Secondary/protocol endpoint

Creatinine (μmol/L)

Time frame:14 weeks

descriptive

Secondary/protocol endpoint

eGFR (ml/min/1.73m2)

Time frame:14 weeks

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Urinary albumin-to-creatinine ratio (mg/g)

Time frame:14 weeks

uACR, change

ratio, improvement

LOINC 9318-7

Cardiometabolic biomarkers

5 endpoints
Secondary/protocol endpoint

Systolic and diastolic blood pressure (mmHg)

Time frame:14 weeks

change from baseline, improvement

Secondary/protocol endpoint

Plasma concentrations of cholesterol

Time frame:14 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Plasma concentrations of low-density lipoproteins

Time frame:14 weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

PPlasma concentrations of high-density lipoproteins

Time frame:14 weeks

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Plasma concentrations of triglycerides

Time frame:14 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Gastrointestinal side effects evaluated using the Gastrointestinal symptom rating scale (GSRS)

Time frame:14 weeks

change from baseline, improvement

Safety / tolerability / PK

6 endpoints
Secondary/protocol endpoint

Percentage time in hypoglycaemia (level 1 [3.0-3.8 mmol/L] and level 2 [below 3.0 mmol/L])

Time frame:14 weeks

descriptive, event

componentsDocumented hypoglycemia

Secondary/protocol endpoint

Plasma concentration of semaglutide (nmol/L)

Time frame:14 weeks

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Dose-corrected plasma concentration of semaglutide (nmol/L)

Time frame:14 weeks

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Plasma amylase (U/L)

Time frame:14 weeks

descriptive

Secondary/protocol endpoint

Incidence of adverse events and serious adverse events

Time frame:14 weeks

Serious AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Secondary/protocol endpoint

Incidence of self-reported hypoglycaemic episodes

Time frame:14 weeks

Documented hypoglycemia

event count, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Daily dose of immunosuppressant (prednisone, cyclosporine, tacrolimus, mycophenolate mofetile)

Time frame:14 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.