Clinical Trial

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

Study acronym: PRIME
Not Yet Recruiting Phase 2/3
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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.
Trial Details
NCT Number NCT07718126
Lead Sponsor West China Hospital
Collaborators: Beijing Friendship Hospital, Anhui Provincial Hospital, The Second Affiliated Hospital of Chongqing Medical University, First Affiliated Hospital of Chongqing Medical University
Conditions Metabolic Dysfunction-Associated Steatohepatitis, Hepatic Steatosis, Living Liver Donors
Enrollment 60 participants
Start Date 2026-09-01
Primary Completion 2028-08-31 (estimated)
Study Completion 2028-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-21