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How does a new drug behave in a damaged liver?

NCT ID NCT07025551

Knowledge-focused Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This completed Phase 1 study looked at how the drug MK-8527 moves through the body in people with mild or moderate liver impairment compared to healthy volunteers. Researchers measured drug levels in the blood over time to understand how liver function affects the drug. The study enrolled 18 participants and also tracked any side effects.

What this could mean

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

Active substance
MK-8527
What this could lead to
If successful, this study could help determine safe dosing of MK-8527 for people with liver problems.
What could go wrong
This is a very early, small study (18 people) focused on drug levels, not treatment effects. Results may not apply to broader populations.

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

18 people

The number who actually took part.

Started

Sep 2025

Finished

Feb 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 to 75 years

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: The main inclusion criteria include but are not limited to the following: All participants: * Is a continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to dosing * Has body mass index (BMI) ≥ 18.0 and ≤ 40.0 kg/m\^2 Participants with Mild HI (Group 1) and Moderate HI (Group 2): * Has mild or moderate hepatic impairment * Has a diagnosis of chronic, stable, hepatic insufficiency with features of cirrhosis due to any etiology * Is generally in good health with the exception of HI Healthy Control Participants (Group 3): \- Healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs Exclusion Criteria: The main exclusion criteria include but are not limited to the following: All participants: * Has a history of cancer (malignancy) * Has positive results for human immunodeficiency virus (HIV) * Has had major surgery and/or donated or lost significant volume of blood within 56 days prior to dosing Participants with Mild HI (Group 1) and Moderate HI (Group 2): * With the exception of HI, has a history or presence of clinically significant medical or psychiatric condition or disease * Is positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) * Is positive for Hepatitis C Virus (HCV)

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Conditions

The condition(s) this trial relates to.

liver disorder

As listed by the trial registrant

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

Healthy participants Hepatic impairment

Contacts and locations

Locations

  • Arizona Clinical Trials ( Site 0001)

    Chandler, Arizona, 85225, United States

More trials for these conditions

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