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

What Was Tested

The trial (phase 2) is built around Semaglutide.

It had two arms (groups): Semaglutide (experimental) and Placebo (placebo comparator).

Placebo administered subcutaneously (under the skin) once weekly.

The registry classes the interventions as drug.

More on the Plan

Weight gain following LT is common and a risk for cardiovascular disease and development of NAFLD.

Developing NAFLD following LT can lead to patients developing scar tissue in the graft (transplanted liver), and graft-cirrhosis.

Semaglutide is a drug that has been approved by the U.

Food and Drug Administration (FDA) for treatment of obesity and Type 2 Diabetes.

Who Took Part

The registry lists 50 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Ability to provide informed consent. Discharged from the hospital following LT surgery. Normal graft function\* (determined by treating hepatologist/surgeon based on clinical status and hepatic panel).

The full record lists 9 inclusion and 14 exclusion criteria; among the exclusions: BMI≤ 27kg/m2; type 1 autoimmune diabetes (by anti-gad (glutamic acid decarboxylase) or history of ketoacidosis); history of gastroparesis.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Semaglutide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-02-22 with completion listed for 2026-08-01.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Change in weight (time frame: Baseline to week 72).

It also tracked 7 secondary outcomes, for example Development of NAFLD, Change in adiposity, Change in insulin resistance, Change in inflammation - C-reactive protein (CRP), Change in inflammation - adiponectin and Change in liver fibrosis markers.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 50 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.