Pre-hepatectomy Rehabilitation in Obese MASLD-Complicated Living Liver Donors With Mazdutide (PRIME)

What Was Tested

In this phase 4 trial, researchers set out to test Mazdutide.

Overweight or obese individuals who intend to donate a portion of their liver but are temporarily disqualified due to hepatic steatosis will be recruited across multiple clinical centers.

Participants will be randomly assigned in a 1:1 ratio to either the experimental group (mazdutide subcutaneous injection once weekly plus standardized lifestyle counseling) or the control group (placebo subcutaneous injection once weekly plus standardized lifestyle counseling).

It had two arms (groups): GLP-1/GCG receptor dual agonist plus lifestyle optimization (GG Group) (experimental) and Lifestyle optimization only (LL group) (placebo comparator).

Subcutaneous injection of a matching placebo once weekly with identical appearance, volume, and injection device for 12 weeks. Standardized lifestyle optimization is identical to the experimental group, consisting of an energy-restricted diet (deficit of 500-750 kcal/day, total daily intake \<=1500 kcal/day) and structured physical exercise (\>=150 minutes/week of moderate-to-high intensity exercise). A matching 1-week placebo washout period is enforced prior to surgery to maintain blinding.

The registry classes the interventions as behavioral and drug.

More on the Plan

Traditional prehabilitation strategies relying solely on lifestyle changes or low-calorie diets often fail to achieve satisfactory histological reversal within the critical, time-sensitive pre-operative window.

This trial aims to validate whether short-term mazdutide intervention can serve as an aggressive prehabilitation tool to accelerate donor downstaging.

Study Design and Procedures: This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial conducted in major transplant centers.

Potential donors will undergo a rigorous two-step screening process: 1.

Who Took Part

Enrollment: 60 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Age between 18 and 60 years old at the time of signing the informed consent form. Overweight, defined as Body Mass Index (BMI) ≥ 24 kg/m². Diagnosed with MASLD by non-invasive means (conventional ultrasound, FibroScan®, or MRI), with a Controlled Attenuation Parameter (CAP) ≥ 268 dB/m via FibroScan®. Histologically confirmed MASLD without any liver fibrosis, presenting a NAS ≥ 3, including a steatosis subscore ≥ 2 (subscores for hepatocyte ballooning and lobular inflammation are not limited). Understands all procedures and follow-up requirements of the study, participates voluntarily, and signs the written informed consent form in person.

The full record lists 6 inclusion and 28 exclusion criteria; among the exclusions: liver biopsy indicates complication with any degree of liver fibrosis; failure to diagnose overweight or masld by non-invasive means, including bmi \< 24 kg/m² and/or cap \< 268 db/m; histological evaluation shows a total nas \< 3 and/or a steatosis subscore \< 2.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

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

It started in 2026-09-01 with completion listed for 2029-02-28.

It ran at 4 sites in China (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Proportion of Participants Achieving Resolution of MASLD Without Worsening of Liver Fibrosis (ROM) (time frame: From randomization (Week 0) to Week 12).

It also tracked 13 secondary outcomes, for example Proportion of Participants Successfully Completing Liver Donation (SCD), Percentage Change from Baseline in Body Weight, Percentage Change from Baseline in Body Mass Index (BMI), Percentage Change from Baseline in Body Fat Percentage, Percentage Change from Baseline in Visceral Fat Content and Daily Net Energy Intake During the Treatment Period.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Mazdutide in 60 people.

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

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