← Trials/Trial dossier/NCT06060392

Sema-Lit

RecruitingPhase NA

Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus

Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus: Sema-Lit

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

50

estimated

Study population

Diabetes (other / unspecified), Liver Transplant; Complications, Obesity / overweight

Key I/E criteria

BMI ≥25HbA1c ≤9%

Primary endpoint

Liver fat content, change

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 IDNCT06060392
Org study IDMMENDO02

Timeline

Milestones

Study first posted2023-09-29actual
Study start2023-10-30actual
Last update posted2025-06-13actual
Primary completion2025-09-02estimated
Study completion2025-11-01estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Diabetes (other / unspecified)Liver Transplant; ComplicationsObesity / overweight

Eligibility

Who can enroll

Minimum age30 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. A man or woman, 30 years of age or above with liver transplantation of at least 3 months duration who meets all the following two criteria:

1. On standard anti-diabetic agents (metformin and/or insulin) with an HbA1c of <=9% at screening

2. Body mass index of >25 kg/m2

2. Subjects must be medically stable based on medical history, physical examination, and laboratory investigations.

3. Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.

4. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of the study and are willing to participate in the study.

Exclusion criteria

1. History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.

2. History of brittle or labile glycemic control, with widely varying glucose measurements by FPG or SMBG such that stable glucose control over the treatment period would be unlikely.

3. History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 3 years before Screening, or an Alcohol Use Disorders Identification Test (AUDIT) with a score >=8, or alcohol consumption of more than 20 g per day in the case of women and more than 30 g per day in the case of men for at least three consecutive months during the previous 5 years.

4. Thyroid stimulating hormone (TSH) value that is either < 0.45 mIU/L or >10 mIU/L at Screening.

Note: Subjects on thyroid hormone replacement therapy must be on a stable dose and dosing regimen for at least 4 weeks prior to enrollment.

5. Use of a PPAR-γ agonist [e.g., a thiazolidinedione (pioglitazone], an SGLT2 inhibitor (e.g., canagliflozin, empagliflozin, dapagliflozin) or GLP-1 receptor agonists (e.g., liraglutide, dulaglutide) within 12 weeks before the enrollment.

6. Ongoing eating disorder, or a significant weight loss or weight gain within 12 weeks before the Screening visit, defined as an increase or decrease of 5% in body weight based upon clinic-based measurement or, if not available, based on subject's report.

7. Myocardial infarction, unstable angina, pulmonary hypertension, revascularization procedure (e.g., stent or bypass graft surgery), or cerebrovascular accident within 3 months before Screening, or revascularization procedure is planned, or subject has a history of New York Heart Association (NYHA) Class III-IV cardiac disease.

8. Use of vitamin E within 4 weeks before screening.

9. History of prior bariatric (e.g., Roux-en-Y gastric bypass) or other major upper gastrointestinal surgical procedure (including gastric resection).

10. History of diabetic gastroparesis (or symptoms suggestive of this disorder, including postprandial bloating or vomiting), malabsorption, inflammatory bowel disease, or any other chronic, clinically important gastrointestinal disorder.

11. Estimated glomerular filtration rate (eGFR) <45 mL/min/1•73 m2 using the Modification of Diet in Renal Disease Study (MDRD) equation.

12. Subjects with a history of having or possibly having metallic material in the body or any contraindication for a MR examination.

13. Claustrophobia, or anxiety related to previous negative experiences with magnetic resonance imaging procedures or if the subject is unwilling to participate in magnetic resonance imaging procedures.

14. Clinically important hematologic disorder (e.g., symptomatic anemia, proliferative bone marrow disorder, thrombocytopenia) at Screening.

15. History of human immunodeficiency virus (HIV) antibody positive at Screening.

16. Contraindications to the use of oral semaglutide (per ORAL SEMAGLUTIDE Prescribing Information).

17. Pregnancy or women breastfeeding or planning to become pregnant while enrolled in this study.

18. History of significant cardiac, vascular, pulmonary, renal, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric disturbances.

19. Patients with history of myopathies or evidence of active muscle disease.

Endpoints (17)

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
6
MASH / liver
6
Cardiometabolic biomarkers
3
Glycemic / diabetes
1
Renal / kidney
1

Weight & body composition

6 endpoints
Secondary/protocol endpoint

Change in pancreatic fat content

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in body weight

Time frame:Baseline to 24 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in body mass index

Time frame:Baseline to 24 weeks

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in total fat percentage

Time frame:Baseline to 24 weeks

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change in lean muscle mass

Time frame:Baseline to 24 weeks

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Change in bone mineral content

Time frame:Baseline to 24 weeks

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change in HbA1c

Time frame:Baseline to 24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

6 endpoints
Primary/protocol endpoint

Change in liver fat content

Time frame:Baseline to 24 weeks

Liver fat content, change

change from baseline, improvement

Secondary/protocol endpoint

Change in controlled attenuation parameter

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in liver stiffness measurement

Time frame:Baseline to 24 weeks

Liver stiffness (VCTE), change

change from baseline, improvement

Secondary/protocol endpoint

Change in aspartate aminotransferase

Time frame:Baseline to 24 weeks

AST, change

change from baseline, improvement

LOINC 1920-8

Secondary/protocol endpoint

Change in alanine aminotransferase

Time frame:Baseline to 24 weeks

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

Change in gamma-glutamyl transpeptidase

Time frame:Baseline to 24 weeks

γ-GT, change

change from baseline, improvement

Renal / kidney

1 endpoint
Secondary/protocol endpoint

Change in serum creatinine concentrations

Time frame:Baseline to 24 weeks

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Change in triglycerides

Time frame:Baseline to 24 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in HDL cholesterol

Time frame:Baseline to 24 weeks

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in LDL-cholesterol

Time frame:Baseline to 24 weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Publications (7)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.