Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07718126 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: PRIME
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Aug 31, 2028 → Feb 28, 2029
See other at-risk trials from West China Hospital

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 31, 2028 to Feb 28, 2029 Show 8 more changesShow less
    • Phase changed: Phase 2/3 → Phase 4
    • Recruitment opened
    • Study completion pushed from Aug 31, 2028 to Aug 31, 2029
    • Study sites: 3 to 4
    • Eligibility criteria shortened, about 11 words
    • Secondary endpoints: 17 to 13
    • Collaborators: 4 to 3
    • Study description shortened, about 3 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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, First Affiliated Hospital of Chongqing Medical University
Conditions
(from sponsor)		 Metabolic Dysfunction-Associated Steatohepatitis, Hepatic Steatosis, Living Liver Donors
Related terms Fatty Liver
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov