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

ConditionNAFLD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Virginia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • Placebo

    Drug

    Placebo solution injected weekly for 72 weeks

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: SemaglutideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in weight

Weight measured in kilograms

Time frame
Baseline to week 72

Secondary outcomes

1

Development of NAFLD

Number of participant who develop NAFLD by the end of treatment will be measured via MRI-PDFF (MRI-Proton Density Fat Fraction). A value of \>5.2% will be considered the threshold for development of NAFLD following LT.

Time frame
Week 72
2

Change in adiposity

Fat distribution of the body body (body composition) will be assessed via MRI (i.e. visceral adipose tissue, abdominal subcutaneous tissue, fat free muscle volume, and muscle fat infiltration, epicardial fat). Means of delta body composition measures after 72 weeks will be compared between the two arms.

Time frame
Baseline to week 72
3

Change in insulin resistance

Frequently Sampled IV Glucose Tolerance Test (FSIVGTT) will be used to measure insulin resistance

Time frame
Baseline to week 72
4

Change in inflammation - C-reactive protein (CRP)

Level of CRP will be assessed using a standard blood test.

Time frame
Baseline to week 72

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Virginia

Lead sponsor

Novo Nordisk A/S

Collaborator

Source ClinicalTrials.gov
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