DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT05424003

RecruitingPhase 2

Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant

A Randomized Double Blinded Placebo-Controlled Trial of Semaglutide to Prevent Weight Gain Following Liver Transplantation

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

50

estimated

Study population

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

Key I/E criterion

•HbA1c ≥6.5%

Primary endpoint

•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 IDNCT05424003
Org study IDHM20024306

Timeline

Milestones

Study first posted2022-06-21actual
Study start2024-02-22actual
Last update posted2025-07-03actual
Primary completion2026-02estimated (month precision)
Study completion2026-02estimated (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Diabetes (other / unspecified)Liver Transplant; ComplicationsObesity / overweightPrediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female age 18-75 years who received LT for any indication (i.e. NASH, hepatitis C, alcohol-induced cirrhosis, autoimmune hepatitis, etc.)
•Liver transplant surgery within 8-24 weeks prior to randomization
•Fasting glucose > 125 mg/dL or presence of diabetes (HbA1c≥6.5% or use of diabetes medications) or pre-diabetes (HbA1c >5.7%)
•Ability to provide informed consent
•Discharged from the hospital following LT surgery
•Tolerating diet
•Normal graft function* (determined by treating hepatologist/surgeon based on clinical status and hepatic panel)
•Stable immunosuppression according the VCU (Virginia Commonwealth University) post-LT protocols ** (i.e. calcineurin inhibitors + mycophenolate)
•Eligible female patients will be (1) non-pregnant, evidenced by a negative urine pregnancy test, (2) non-lactating, (3)surgically sterile or post-menopausal, or they will agree to continue to use an accepted method of birth control during the study

Exclusion criteria

•BMI≤ 27kg/m2
•GFR (Glomerular Filtration Rate) ≤ 25 ml/min/1.73m2
•Type 1 autoimmune diabetes (by anti-GAD (glutamic acid decarboxylase) or history of ketoacidosis)
•History of gastroparesis
•Familial or personal history of medullary thyroid cancer or MEN (Multiple Endocrine Neoplasia) 2
•History of pancreatitis
•History of active malignancy post- LT with the exception of non-melanoma skin cancers
•History of uncontrolled or unstable diabetic retinopathy or maculopathy
•Acute cellular rejection
•Hepatic artery thrombosis
•Medical non-compliance
•Active treatment with GLP (glucagon-like peptide)-1RA (receptor agonist) or SGLT (sodium-glucose cotransporter)-2 inhibitors at time of screening
•History of hypersensitivity to semaglutide or its excipients
•Women who are nursing, pregnant, or planning to become pregnant during the study, or are not using adequate contraceptive measures

Endpoints (8)

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

Cardiometabolic biomarkers
3
Weight & body composition
2
MASH / liver
2
Glycemic / diabetes
1

Weight & body composition

2 endpoints
Primary/protocol endpoint

Change in weight

Time frame:Baseline to week 72

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in adiposity

Time frame:Baseline to week 72

change from baseline, improvement

componentsVisceral fat, change, Subcutaneous fat, change, Lean mass

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change in insulin resistance

Time frame:Baseline to week 72

HOMA-IR (insulin sensitivity)

change from baseline, improvement

MASH / liver

2 endpoints
Secondary/protocol endpoint

Development of NAFLD

Time frame:Week 72

threshold achievement, improvement

Secondary/protocol endpoint

Change in liver fibrosis markers

Time frame:Baseline to week 72

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Change in inflammation - C-reactive protein (CRP)

Time frame:Baseline to week 72

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in inflammation - adiponectin

Time frame:Baseline to week 72

Adiponectin, change

change from baseline, improvement

Secondary/protocol endpoint

Change in serum lipid profile

Time frame:Baseline to week 72

change from baseline, improvement

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.