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New cholesterol drug tested in liver patients

NCT ID NCT06575959

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This completed Phase 1 study looked at how the experimental cholesterol-lowering drug enlicitide is processed in the body of people with mild or moderate liver impairment compared to healthy volunteers. Twenty participants received a single oral dose, and researchers measured drug levels in the blood over time. The goal is to understand if liver problems affect how the drug is handled, which could guide future dosing recommendations.

What this could mean

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

Active substance
enlicitide (oral tablet)
What this could lead to
If successful, this study could help doctors determine the right dose of enlicitide for people with liver problems, making the drug safer and more effective.
What could go wrong
This is a very early, small study (20 people) focused on drug levels, not on whether enlicitide actually lowers cholesterol or improves health. Results may not apply to all patients.

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

20 people

The number who actually took part.

Started

Sep 2024

Finished

May 2025

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: * Has been a non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to starting the study * Has body mass index (BMI) ≥ 18.0 and ≤ 40.0 kg/m2 Participants with moderate or mild HI: * Diagnosis of chronic (\> 6 months) and stable (no sudden or severe episodes of illness due to worsening liver function in the past 2 months) hepatic insufficiency, and features cirrhosis (liver scarring) due to any cause. * Is generally in good health with the exception of HI. Healthy Control Participants: * Medically healthy with no clinically significant medical history, physical examination, or clinical laboratory profiles Exclusion Criteria: The main exclusion criteria include but are not limited to the following: All participants: * History of gastrointestinal disease which may affect food and drug absorption, or has had a gastric bypass or similar surgery. * History of cancer * Consumes greater than 3 servings of alcoholic beverages per day. * Is on statin background therapy. Participants with moderate or mild HI: * Severe complications of liver disease within 3 months of entering the study.

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Conditions

The condition(s) this trial relates to.

Hepatic Insufficiency liver disorder liver failure

As listed by the trial registrant

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

Hepatic impairment Hepatic insufficiency

Contacts and locations

Locations

  • Orlando Clinical Research Center ( Site 0002)

    Orlando, Florida, 32809, United States

  • The Texas Liver Institute ( Site 0001)

    San Antonio, Texas, 78215, United States

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