A Single-Dose Pharmacokinetic Study of Eloralintide in Subjects with Normal Hepatic Function and Varying Degrees of Hepatic Impairment

The primary objective is to evaluate the pharmacokinetics of a single dose of eloralintide in subjects presenting with hepatic impairment ranging from mild to severe, compared to subjects with normal liver function. This assessment is clinically significant to determine how varying degrees of liver dysfunction influence the absorption, distribution, metabolism, and excretion of the study drug. No secondary objectives were identified.

This study involves a total of 20 participants consisting of both patients and healthy volunteers. The cohort includes both males and females within specific age ranges. The study population encompasses individuals with normal hepatic function as well as those presenting with mild, moderate, or severe hepatic impairment.

This Phase 3 pharmacokinetic study is designed to evaluate the profile of Eloralintide in individuals with varying degrees of hepatic impairment and those with normal liver function. The research methodology involves a single-dose administration to assess how liver function affects the drug's disposition. The study protocol includes a screening visit to determine eligibility, followed by the administration of the study product. Subsequent follow-up visits are conducted to monitor physiological responses and gather necessary data. The sequence concludes with an end-of-study visit. The estimated duration of the study period extends from May 2026 to March 2027. Early termination from the study may occur based on predefined safety criteria or clinical requirements.

The efficacy assessment for this Phase 3 clinical trial is not specified in the provided documentation. The study population includes individuals with mild, moderate, or severe hepatic impairment as well as those with normal hepatic function.