MDR-001 Phase 1 Pharmacokinetics and Safety Study in Hepatic Impairment
Summary
A Phase 1 single-center, open-label, parallel-group study evaluating the pharmacokinetics and safety of MDR-001, a GLP-1 receptor agonist, has been registered on ClinicalTrials.gov under NCT07550634. The study will administer a single oral dose to participants with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment and to matched healthy controls. Primary pharmacokinetic endpoints are AUC and Cmax; safety endpoints include adverse events, vital signs, ECG, and laboratory assessments.
“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.”
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What changed
A new Phase 1 clinical trial (NCT07550634) has been registered on ClinicalTrials.gov for MDR-001, a GLP-1 receptor agonist. The single-center, open-label, parallel-group study will evaluate pharmacokinetics (AUC and Cmax) and safety in participants with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment compared to matched healthy controls following a single oral dose.
This trial registration is informational and does not create compliance obligations. Drug developers and clinical investigators reviewing this entry will note it covers a hepatic impairment study, which is a standard required assessment for drugs with hepatic metabolism or excretion. The study adds to the body of clinical evidence for GLP-1 receptor agonists in special populations.
Archived snapshot
Apr 25, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Pharmacokinetics and Safety of MDR-001 in Mild and Moderate Hepatic Impairment
Phase 1 NCT07550634 Kind: PHASE1 Apr 24, 2026
Abstract
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.
Conditions: Hepatic Impairment (Mild and Moderate, Child-Pugh Class A and B), Hepatic Insufficiency (MeSH ID: D048550)
Interventions: MDR-001
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