Trial · Interventional
RecruitingPhase 4Registry dataPre-hepatectomy Rehabilitation in Obese MASLD-Complicated Living Liver Donors With Mazdutide (PRIME)
Short name PRIME
Overview
- Status
- Recruiting
- Phase
- Phase 4
- Enrollment
- 60 participants (estimated)
- Sponsor
- West China Hospital · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
China
- Start
- 1 Sept 2026
- Primary completion
- 28 Feb 2029 (estimated)
- Completion
- 31 Aug 2029 (estimated)
- First posted
- 21 Jul 2026
- Last update posted
- 23 Sept 2026
- Conditions
- Metabolic Dysfunction-Associated Steatohepatitis · Hepatic Steatosis · Living Liver Donors
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to evaluate the efficacy and safety of a short-term (12-week) prehabilitation strategy combining mazdutide (a novel GLP-1/GCG receptor dual agonist) with lifestyle optimization, compared to lifestyle optimization alone, in potential living liver transplantation donors with metabolic dysfunction-associated steatohepatitis (MASLD). 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). The primary objective is to determine whether the short-term addition of mazdutide can significantly increase the proportion of donors achieving histological resolution of hepatic steatosis without the worsening of fibrosis within 12 weeks. The study ultimately aims to provide high-quality evidence for a rapid, safe, and effective surgical prehabilitation protocol to expand the living donor pool and optimize perioperative outcomes for both donors and recipients.
Interventions
- MazdutideDrug
- Placebo (Normal Saline)Drug
- Lifestyle OptimizationBehavioral
Arms2
Experimental
GLP-1/GCG receptor dual agonist plus lifestyle optimization (GG Group)
Subcutaneous injection of mazdutide once weekly following a 12-week dose-escalation regimen: 2 mg q1w for Weeks 1-2, 4 mg q1w for Weeks 3-4 (if gastrointestinal tolerated), and a target dose of 6 mg q1w from Week 5 to Week 12 (if gastrointestinal tolerated). Standardized lifestyle optimization consists 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 mandatory 1-week drug washout period is enforced prior to surgery.
Placebo comparator
Lifestyle optimization only (LL group)
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Proportion of Participants Achieving Resolution of MASLD Without Worsening of Liver Fibrosis (ROM)
Time frame · From randomization (Week 0) to Week 12
Registry description
Percentage of participants who achieve histological resolution of MASLD. Resolution is defined based on the second liver biopsy as a NAFLD Activity Score (NAS) steatosis subscore \<= 1, a hepatocyte ballooning subscore = 0, and a lobular inflammation subscore \<= 1. Additionally, to meet the criteria for resolution, there must be no increase in the total NAS, hepatocyte ballooning, or lobular inflammation subscores, and no worsening of liver fibrosis compared to the baseline liver biopsy.
Secondary outcomes(13)
Proportion of Participants Achieving Ultrasound-Assessed Improvement of Hepatic Steatosis (uIOS)
Time frame · From randomization (Week 0) up to Week 12
Registry description
Percentage of participants who achieve improvement of hepatic steatosis evaluated by FibroScan®. Improvement is defined as the Controlled Attenuation Parameter (CAP) dropping to \< 268 dB/m.
Proportion of Participants Achieving Imaging-Assessed Improvement of Hepatic Steatosis (iIOS)
Time frame · From randomization (Week 0) up to Week 12
Registry description
Percentage of participants who achieve improvement of hepatic steatosis evaluated by Magnetic Resonance Imaging (MRI). Improvement is defined as the MRI Proton Density Fat Fraction (MRI-PDFF) dropping to \< 15%.
Proportion of Participants Achieving Improvement of MASLD Without Worsening of Liver Fibrosis (IOM)
Time frame · From randomization (Week 0) up to Week 12
Registry description
Percentage of participants achieving MASLD improvement evaluated by liver biopsy. It is defined as a decrease in the total NAS by \>= 2 or a total NAS \<= 3, with a steatosis subscore \<= 1, while maintaining no increase in subscores for hepatocyte ballooning or lobular inflammation, and no worsening of liver fibrosis.
Proportion of Participants Achieving Improvement of Hepatic Steatosis Without Worsening of MASLD (IOS)
Time frame · From randomization (Week 0) up to Week 12
Registry description
Percentage of participants achieving steatosis improvement evaluated by liver biopsy. It is defined as a decrease in the total NAS by \>= 1 and a NAS steatosis subscore \<= 1, while maintaining no increase in total NAS, hepatocyte ballooning, or lobular inflammation subscores, and no worsening of liver fibrosis.
Proportion of Participants Successfully Completing Liver Donation (SCD)
Time frame · From randomization (Week 0) up to Week 24
Registry description
Percentage of participants who successfully fulfill the clinical criteria for living donor liver transplantation and complete the liver procurement surgery.
Percentage Change from Baseline in Body Weight
Time frame · From randomization (Week 0) up to Week 12
Registry description
Relative change in body weight measured in percentage using calibrated electronic scales under fasting conditions.
Percentage Change from Baseline in Body Mass Index (BMI)
Time frame · From randomization (Week 0) up to Week 12
Registry description
Relative change in BMI calculated as weight in kilograms divided by height in meters squared.
Percentage Change from Baseline in Body Fat Percentage
Time frame · From randomization (Week 0) up to Week 12
Registry description
Relative change in body fat percentage evaluated using the Bioelectrical Impedance Analysis (BIA) method.
Percentage Change from Baseline in Visceral Fat Content
Time frame · From randomization (Week 0) up to Week 12
Registry description
Relative change in visceral fat volume and content quantitatively assessed via abdominal MRI scans.
Daily Net Energy Intake During the Treatment Period
Time frame · From randomization (Week 0) up to Week 12
Registry description
Daily net energy intake calculated based on the total daily energy expenditure estimated by smart fitness trackers minus the daily dietary calorie intake self-reported via electronic questionnaires.
Time to Ultrasound-Assessed Hepatic Steatosis Improvement
Time frame · From randomization (Week 0) up to Week 12
Registry description
The number of days from randomization to the first documentation of hepatic steatosis improvement, defined as a CAP score \< 268 dB/m via regular FibroScan® assessments.
Time to Successful Liver Donation
Time frame · From randomization (Week 0) up to Week 24
Registry description
The number of days from randomization to the date of the successful liver procurement surgery.
Change from Baseline in Health-Related Quality of Life (HRQoL) Score
Time frame · From randomization (Week 0) up to Week 12
Registry description
Change in patient-reported quality of life assessed using the validated Chinese version of the Short Form-36 (SF-36) questionnaire. Total scores range from 0 to 100 for each subscale, with higher scores representing better health status and quality of life.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
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Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 60 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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