Phase 1 Study Evaluating Single-Dose Petrelintide Pharmacokinetics and Safety in Adults With Normal and Impaired Liver Function

What this Trial Is About

Researchers are evaluating the investigational drug petrelintide to understand how it behaves in the body, especially focusing on people with impaired liver function compared to those with normal liver function. This Phase 1, open-label study aims to explore the pharmacokinetics, safety, and tolerability of a single dose of petrelintide in adults with varying degrees of hepatic impairment and those with normal hepatic function. Participants will receive one single subcutaneous injection of petrelintide on the first day of the study. The study includes up to 36 adults divided into groups based on liver function normal, mild, moderate, and severe hepatic impairment, with 6 participants in each impaired group and up to 18 with normal liver function. The classification follows the Child-Pugh system. During the trial, participants will be monitored from the day of dosing until Day 50, including blood tests to measure how the drug is processed, safety evaluations, and tracking any side effects. Researchers will measure various pharmacokinetic parameters such as drug concentration over time, clearance, and half-life. Safety will be assessed by recording any adverse events during the follow-up period.

Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function