CompletedPhase 1

A Study to Evaluate EDG-7500 in Adults With Hepatic Impairment

United States25 participantsStarted 2026-01-26

Plain-language summary

The purpose of this Phase 1 study is to understand and compare the amount of EDG-7500 in the blood after a single dose in participants with different levels of liver function impairment versus participants with normal liver function. The safety of EDG-7500 in adult participants with different levels of liver function impairment will also be evaluated in this study.

Who can participate

Age range

18 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

Medically healthy, including the following:

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

Area under the plasma concentration time-curve from time zero to the last measured concentration (AUC0-last)

Timeframe: Pre-dose to day 10

Area under the plasma concentration time-curve from time zero extrapolated to infinity (AUC0-inf)

Timeframe: Pre-dose to day 10

Maximum observed plasma concentration (Cmax)

Timeframe: Pre-dose to day 10

Trial details

NCT IDNCT07324616

SponsorEdgewise Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-07

View on ClinicalTrials.gov More Hepatic Impairment (HI) trials

Plain-language summary

What they're measuring

Area under the plasma concentration time-curve from time zero to the last measured concentration (AUC0-last)

Timeframe: Pre-dose to day 10

Area under the plasma concentration time-curve from time zero extrapolated to infinity (AUC0-inf)

Timeframe: Pre-dose to day 10

Maximum observed plasma concentration (Cmax)

Timeframe: Pre-dose to day 10