Not Yet RecruitingPhase 1

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

China32 participantsStarted 2026-06-01

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Voluntary signed informed consent before any study-related activities, and ability to understand the study procedures and methods, and willingness to strictly comply with the protocol to complete the study.
. Participants (including their partners) must have no pregnancy plan and voluntarily take effective contraceptive measures from screening until 6 months after study drug administration.
. Age 18 to 70 years (inclusive), male or female.
. Male body weight ≥50 kg, female body weight ≥45 kg; body mass index (BMI) between 18 and 32 kg/m² (inclusive).
. Estimated glomerular filtration rate (eGFR, calculated by CKD-EPI formula) ≥60 mL/min/1.73m².
. Additional criteria for participants with hepatic impairment:

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary pharmacokinetic (PK) parameters of MDR-001

Timeframe: Baseline (Day 1 pre-dose) and at 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose on Day 1 (single dose).

Primary pharmacokinetic (PK) parameters of MDR-001

Timeframe: Baseline (Day 1 pre-dose) and at 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose on Day 1 (single dose).

Primary pharmacokinetic (PK) parameters of MDR-001

Timeframe: Baseline (Day 1 pre-dose) and at 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose on Day 1 (single dose).

Trial details

NCT IDNCT07550634

SponsorMindRank AI Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-08

Contact for this trial

Guodong Li, PhD

+86 18968027256 guodong.li@mindrank.cn

View on ClinicalTrials.gov More Hepatic Impairment (Mild and Moderate, Child-Pugh Class A and B) trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Voluntary signed informed consent before any study-related activities, and ability to understand the study procedures and methods, and willingness to strictly comply with the protocol to complete the study.
. Participants (including their partners) must have no pregnancy plan and voluntarily take effective contraceptive measures from screening until 6 months after study drug administration.
. Age 18 to 70 years (inclusive), male or female.
. Male body weight ≥50 kg, female body weight ≥45 kg; body mass index (BMI) between 18 and 32 kg/m² (inclusive).
. Estimated glomerular filtration rate (eGFR, calculated by CKD-EPI formula) ≥60 mL/min/1.73m².
. Additional criteria for participants with hepatic impairment:

Exclusion criteria

What they're measuring

Primary pharmacokinetic (PK) parameters of MDR-001

Timeframe: Baseline (Day 1 pre-dose) and at 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose on Day 1 (single dose).

Primary pharmacokinetic (PK) parameters of MDR-001

Timeframe: Baseline (Day 1 pre-dose) and at 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose on Day 1 (single dose).

Primary pharmacokinetic (PK) parameters of MDR-001

Timeframe: Baseline (Day 1 pre-dose) and at 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose on Day 1 (single dose).