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Life sciences · Phase 4 Trial
ClinicalTrials.gov · September 23, 2026
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Phase 4 Trial.
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Registry record from ClinicalTrials.gov (NCT07718126). This is a study registration, not published results. Lead sponsor: West China Hospital. Recruitment status: RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Metabolic Dysfunction-Associated Steatohepatitis, Hepatic Steatosis, Living Liver Donors. Interventions: DRUG: Mazdutide; DRUG: Placebo (Normal Saline); BEHAVIORAL: Lifestyle Optimization. Primary outcome measures: Proportion of Participants Achieving Resolution of MASLD Without Worsening of Liver Fibrosis (ROM) , From randomization (Week 0) to Week 12. Brief summary: 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.