DelfaGLP-1 Atlas

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Enrolling by invitationPhase 4

Semaglutide vs Sitagliptin

The GLP-1 Agonist Semaglutide for the Treatment of Metabolic Disease in Liver Transplant Recipients: A Phase IV, Randomized Trial

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

58

estimated

Study population

Diabetes (other / unspecified), Liver Transplant; Complications, Type 2 diabetes

Key I/E criterion

•HbA1c 6.5-10.5%

Primary endpoints

•HbA1c, change•Body weight, absolute change (kg)

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 IDNCT05195944
Org study ID21-5640
Secondary IDU1111-1268-1934WHO UTN

Timeline

Milestones

Study first posted2022-01-19actual
Study start2022-10-26actual
Last update posted2026-04-06actual
Primary completion2026-12estimated (month precision)
Study completion2026-12estimated (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Diabetes (other / unspecified)Liver Transplant; ComplicationsType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female, age ≥18 years at the time of signing informed consent.
•Willing and able to provide informed consent.
•Recipient of liver graft (Liver/Kidney recipients and retransplants allowed)
•Time from transplant surgery ≥ 3 months at time of screening visit with no evidence of active rejection. Liver enzymes must be stable with elevations no greater than 2xULN. However, if patients have elevated liver enzymes beyond 2xULN due to NASH, as confirmed on liver biopsy, they may be included.
•Patient diagnosed with type 2 diabetes or post-transplant diabetes
•Patients transplanted for hepatocellular carcinoma may be included provide their latest surveillance imaging is negative for recurrence
•The use of any immunosuppression regimen (calcineurin inhibitors, mycophenolate mofetil, maintenance prednisone or sirolimus) is acceptable
•HbA1c 6.5-10.5% (53-91 mmol/mol) (both inclusive, not under optimal glycemic control).

For purposes of clarification, patients on stable treatment with one of the following insulin regimens (minimum 10 IU/day) ≥ 90 days prior to the day of screening, may be included (maximum 20% change in total daily dose within the 90 days is acceptable):

•Basal insulin alone
•Basal and bolus insulin in any combination
•Premixed insulin including combinations of soluble insulin Concomitant treatment with stable daily dose of metformin and/or an SGLT2 inhibitor ≥ 90 days prior to the day of screening is allowed.

Being on insulin, metformin, and/or an SGLT-2 inhibitor is optional.

Exclusion criteria

•Known or suspected hypersensitivity to trial products or related products.
•Previous participation in this trial.
•Active graft dysfunction that requires investigation (at screening).
•Currently receiving steroids (prednisone) for treatment of acute cellular rejection.
•Patients transplanted for multisystem genetic disorders such as amyloidosis or cystic fibrosis.
•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly-effective contraceptive methods ().
•Receipt of any investigational medicinal product within 90 days before screening.
•Any disorder or medical condition which, in the investigator's opinion, might jeopardize patient's safety or compliance with the protocol.
•Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC).
•History of pancreatitis (acute or chronic).
•History of major surgical procedures involving the stomach and potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
•Any of the following: myocardial infarction (MI), stroke or hospitalization for unstable angina or transient ischemic attack within the past 180 days prior to the day of screening and randomization.
•Classified as being in New York Heart Association (NYHA) Class IV.
•Planned coronary, carotid or peripheral artery revascularization known on the day of screening.
•Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73 m2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI).
•Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. An exception is short-term change of insulin treatment for acute illness for a total of ≤ 14 days.
•Known history of proliferative retinopathy or maculopathy requiring acute treatment, unless stable
•History or presence of actively treated malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer, hepatocellular carcinoma, and carcinoma in situ.)

Endpoints (9)

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

Weight & body composition
4
Glycemic / diabetes
2
MASH / liver
2
Safety / tolerability / PK
1

Weight & body composition

4 endpoints
Primary/protocol endpoint

Change in body weight (kg)

Time frame:Baseline to week 26

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in body weight %

Time frame:Baseline to 26 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Body mass index (BMI)

Time frame:Baseline to 26 weeks

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:Baseline to 26 weeks

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint

Change in HbA1c level

Time frame:Baseline to 26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting plasma glucose

Time frame:Baseline to 26 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

MASH / liver

2 endpoints
Other/protocol endpoint

Change in aspartate aminotransferase (AST) level

Time frame:baseline to 26 weeks

AST, change

change from baseline, improvement

LOINC 1920-8

Other/protocol endpoint

Change in alanine aminotransferase (ALT) level

Time frame:baseline to 26 weeks

ALT, change

change from baseline, improvement

LOINC 1742-6

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Number of treatment-emergent adverse events

Time frame:26 weeks

Treatment-emergent AEs (any)

event count, event

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.