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New drug EDG-7500 put to the test in liver health study

NCT ID NCT07324616

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This early-stage study is testing a single dose of an experimental drug called EDG-7500 in 32 adults. Some have mild or moderate liver problems, while others have normal liver function. Researchers want to see how the drug moves through the body and if it is safe in people with different levels of liver function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EDG-7500
What this could lead to
If successful, this study could help determine safe dosing of EDG-7500 for people with liver problems.
What could go wrong
This is a very early Phase 1 study with only 32 participants. It is designed to measure drug levels, not to treat any disease, so it may not lead to a treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

25 people

The number who actually took part.

Started

Jan 2026

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: All Participants * Adult, male or female, ≥ 18 years of age. * Female and male participants must follow protocol-specified contraception guidance. * Continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to dosing. * BMI ≥ 18.0 and ≤ 40.0 kg/m2 at screening. * eGFR \>60 mL/min calculated using the 2021 CKD-EPI creatinine equation. Participants with Mild and Moderate Hepatic Impairment (HI) * With the exception of HI, is in generally good health for study participation including the following: * Pulse rate is ≥ 40 bpm and ≤ 110 bpm at screening. * QTcF interval is ≤ 500 msec and has ECG findings considered normal or not clinically significant. * Has impaired hepatic function as defined by the Child-Pugh classification for severity of liver disease and has a Child-Pugh score in line with one of the following HI cohorts at screening: * Mild HI (Class A): Child-Pugh score of 5 to 6, inclusive. * Moderate HI (Class B): Child-Pugh score of 7 to 9, inclusive. * Has a diagnosis of chronic (\> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency. Participants with Normal Hepatic Function: -Medically healthy, including the following: * Blood pressure is ≥ 90/40 mmHg and ≤ 150/95 mmHg. * Pulse rate is ≥ 40 bpm and ≤ 100 bpm. * QTcF interval is ≤ 470 msec and has ECG findings considered normal or not clinically significant. * Liver function test including ALT ≤ ULN, AST ≤ ULN, and total bilirubin ≤1.5x ULN. Exclusion Criteria: All Participants * History or presence of alcohol or drug abuse within the past 1 year prior to dosing. * Female participant with a positive pregnancy test at the screening visit or at check-in or who is lactating or breastfeeding. * Positive urine or breath alcohol results at screening or check-in. Unable to refrain from or anticipates the use of any drugs. * Positive results for HIV at screening. * Donation of blood or significant blood loss within 56 days prior to dosing. * Plasma donation within 7 days prior to dosing. * Participation in another clinical study within 30 days or within 5 half-lives (if known), prior to dosing. Participants with Mild and Moderate HI * With the exception of HI, history or presence of clinically significant medical or psychiatric condition or disease, or any illness that might confound the results of the study or poses an additional risk to the participant by their participation in the study. * History of severe complications of liver disease within the preceding 3 months of screening. * Primary biliary cholangitis or biliary obstruction at screening. * Fluctuating or rapidly deteriorating hepatic function from screening until prior to dosing. * History of liver or other solid organ transplantation. * Requires paracentesis more often than 2 times per month. * Transjugular intrahepatic portosystemic shunt and/or has undergone portacaval shunting within 90 days prior to screening. * Received antiviral and/or immune modulating therapy for active hepatitis infection within 90 days prior to dosing. * Diabetic participants with HbA1c \> 8.5% at screening. * Positive for HBsAg or HBcAb and has positive hepatitis B virus DNA at screening. * Positive for HCV and has a detectable HCV viral load at screening. Participants with Normal Hepatic Function * History or presence of clinically significant medical or psychiatric condition or disease, or any illness that might confound the results of the study or poses an additional risk to the participant by their participation in the study. * Alcohol consumption \> 14 drinks per week for males (7 for females) within 45 days of screening. * Positive result for HBsAg or HCV at screening.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Orlando Clinical Research Center

    Orlando, Florida, 32809, United States

  • The University of Miami Division of Clinical Pharmacology

    Miami, Florida, 33136, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.