Pharmacokinetics and Safety of MDR-001 in Mild and Moderate Hepatic Impairment

Summary

This is a Phase I, single-center, open-label, parallel-group study. A single oral dose of MDR-001, a GLP-1 receptor agonist, will be administered to participants with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment and to matched healthy controls. The study aims to evaluate the pharmacokinetics and safety of MDR-001 in these populations. Primary pharmacokinetic endpoints include AUC and Cmax; safety endpoints include adverse events, vital signs, ECG, and laboratory assessments.

Timeline

Start

2026-06-01

Primary completion

2026-07-08

Completion

2026-10-30

Drugs

Indications