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

NCT05424003 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HM20024306
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, semaglutide will be compared to placebo (a look-alike inactive substance, a "sugar pill") to determine if its use will prevent weight gain after liver transplantation (LT). In addition, researchers will be testing to determine if semaglutide prevents the development of Non-Alcoholic Fatty Liver Disease (NAFLD) after transplant through Magnetic Resonance Imaging (MRI) and laboratory results.

Conditions

NAFLD

Keywords

Liver Transplant

Outcome Measures

Primary Outcomes (1)

• Change in weight

  Weight measured in kilograms

  Baseline to week 72

Secondary Outcomes (7)

• Development of NAFLD

  Week 72

• Change in adiposity

  Baseline to week 72

• Change in insulin resistance

  Baseline to week 72

• Change in inflammation - C-reactive protein (CRP)

  Baseline to week 72

• Change in inflammation - adiponectin

  Baseline to week 72

Study Arms (2)

Semaglutide

EXPERIMENTAL

Semaglutide administered subcutaneously (under the skin) once weekly. There will be a 20 week lead in period of dose escalation before reaching the target dose of 2.4mg weekly. Semaglutide will then be administered at the maximum tolerated dose for 52 weeks.

Drug: Semaglutide Pen Injector

Placebo

PLACEBO COMPARATOR

Placebo administered subcutaneously (under the skin) once weekly.

Drug: Placebo

Interventions

Semaglutide Pen Injector DRUG

Starting dose of 0.24 mg injected weekly and increased every 4 weeks to a potential maximum dose of 2.4 mg weekly at 20 weeks followed by 52 weeks of weekly injections at the maximum tolerable dose

Also known as: Wegovy

Semaglutide

Placebo DRUG

Placebo solution injected weekly for 72 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Mohammad S Siddiqui, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherry Boyett, RN

CONTACT

804-828-5434; sherry.boyett@vcuhealth.org

Mohammad S Siddiqui, MD

CONTACT

mohammad.siddiqui@vcuhealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 21, 2022
• Study Start: February 22, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)