Mazdutide + Lifestyle Prehabilitation Aims to Resolve MASLD in Obese Living Liver Donors
Background
Metabolic dysfunction-associated steatohepatitis (MASLD), characterized by hepatic steatosis and inflammation, is a significant barrier for obese individuals seeking to become living liver donors. Current lifestyle interventions often fall short in achieving rapid and sufficient histological improvement to qualify donors. Expanding the donor pool is critical given the global organ shortage. Mazdutide, a novel dual GLP-1 and glucagon receptor agonist, offers a promising pharmacological approach by promoting weight loss and improving metabolic parameters, potentially reversing steatosis and enabling more individuals to donate.
Study Design
This multi-center, randomized, placebo-controlled clinical trial (PRIME study) will recruit overweight or obese individuals temporarily disqualified from living liver donation due to hepatic steatosis. Participants will be randomized 1:1 to receive either mazdutide subcutaneous injection once weekly or placebo once weekly, both combined with standardized lifestyle counseling, for 12 weeks. The primary objective is to determine if mazdutide significantly increases the proportion of donors achieving histological resolution of hepatic steatosis without worsening fibrosis, assessed via liver biopsy.
Why It Matters
If successful, this study could establish a rapid, safe, and effective surgical prehabilitation protocol, significantly expanding the pool of eligible living liver donors. Mazdutide could become a critical tool for clinicians to optimize donor health and improve perioperative outcomes for both donors and recipients. This protocol could offer a novel strategy for individuals with MASLD to qualify for donation, potentially reducing waitlist mortality and improving access to life-saving transplants. The 12-week duration suggests a practical, short-term intervention.
mazdutide
masld
obesity
liver-transplantation
prehabilitation
rct-protocol