Efficacy and Safety of Tirzepatide for the Treatment of Obesity in Liver Transplant Candidates

The primary objective is to evaluate the efficacy and safety of pharmacological treatment for obesity in patients with a body mass index (BMI) of 30 or greater who are candidates for liver transplantation. This investigation utilizes tirzepatide administered via subcutaneous injection to determine its impact on weight management within this specific clinical population.

The sponsor did not provide information regarding the total number of participants. The study population consists of patients diagnosed with obesity who are candidates for liver transplantation. Eligible individuals are aged 18 years or older and are undergoing pre-transplant evaluation in either an inpatient or outpatient setting. Inclusion requires a body mass index (BMI) of at least 30, or a BMI of at least 33 in instances involving significant fluid retention, such as ascites, edema, or hydrothorax. Participants must be clinically stable, characterized by either outpatient follow-up or hospitalization in a standard ward without signs of significant clinical or laboratory deterioration. Both males and females are included in the study.

This study is designed to evaluate the efficacy and safety of tirzepatide in patients with obesity who are candidates for liver transplantation. The investigation involves the administration of Mounjaro at doses of 2.5 mg or 5 mg via subcutaneous injection. The research methodology includes a screening visit to assess eligibility based on a body mass index (BMI) of ≥ 30, or ≥ 33 in cases of significant fluid retention, and clinical stability. The primary endpoint is the absolute and relative change in body weight, BMI, and body fat composition during the follow-up period. Secondary endpoints include the assessment of adverse events, complications related to underlying liver disease while on the waiting list, and post-transplant outcomes such as patient survival and graft survival at one, three, and six months. The total trial period is estimated to extend from January 2027 to December 2030.

The experimental treatment consists of tirzepatide, provided as a solution for injection in a pre-filled pen. The administration involves a subcutaneous injection at doses of either 2.5 mg or 5 mg.

The efficacy of pharmacological treatment for obesity will be evaluated using several parameters. The primary endpoint consists of the absolute change and relative change in body weight, body mass index, and body fat composition during the follow-up period.

Secondary endpoints include the occurrence of complications related to the underlying liver disease while on the waiting list. Additional evaluations involve monitoring post-transplant complications, patient survival, and graft survival at 1-month, 3-month, and 6-month timepoints. The safety of the treatment will be assessed through the monitoring of adverse events.