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

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.

NCT Number	NCT07550634
Lead Sponsor	MindRank AI Ltd
Conditions	Hepatic Impairment (Mild and Moderate, Child-Pugh Class A and B), Hepatic Insufficiency (MeSH ID: D048550)
Enrollment	32 participants
Start Date	2026-06-01
Primary Completion	2026-07-08 (estimated)
Study Completion	2026-10-30 (estimated)
Updated on ClinicalTrials.gov	2026-04-24