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New drug tested in people with liver disease – early safety check

NCT ID NCT07519135

Knowledge-focused Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage study is testing an investigational drug called PF-08653944 in 26 adults, some with healthy livers and others with mild to severe liver impairment. Researchers want to see how liver function affects the way the body processes the drug and whether it is safe. Participants receive a single injection and are monitored closely. The study is not expected to provide direct medical benefit but will guide future research.

What this could mean

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

Active substance
PF-08653944 (also called MET097)
What this could lead to
If successful, this study could help determine safe dosing of PF-08653944 for people with liver disease.
What could go wrong
This is a very early Phase 1 study with only 26 participants. It is not designed to test if the drug works, only how it is processed and tolerated.

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

About 26 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

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 74 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: * Adults 18 to 75 years of age, male or female. * BMI ≥21 kg/m² and body weight \>50 kg at screening. * Group 1 (without hepatic impairment): * No known or suspected hepatic impairment. * Normal liver function tests (ALT, AST, bilirubin, albumin, PT within normal limits, with protocol-specified exceptions such as Gilbert's syndrome). * Groups 2-4 (with hepatic impairment): * Stable hepatic impairment classified as Child-Pugh Class A (mild), B (moderate), or C (severe). * No clinically significant worsening of hepatic status within 28 days prior to screening. * Women of childbearing potential must not be pregnant or breastfeeding and must agree to use highly effective contraception. Exclusion Criteria: * Clinically significant medical or psychiatric conditions, including recent or active suicidal ideation or behavior. * Use of GLP-1 receptor agonists within 90 days (or 5 half-lives) prior to dosing. * Participation in another investigational study or receipt of an investigational product within 30 days (or 5 half-lives) prior to dosing. * For hepatic-impairment groups only: * Hepatic carcinoma, hepatorenal syndrome, or limited life expectancy. * Clinically active Grade 3 or 4 hepatic encephalopathy. * Severe uncontrolled ascites, recent gastrointestinal bleeding, or history of solid organ transplant.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Floridian Clinical Research

    RECRUITING

    Miami Lakes, Florida, 33016, United States

  • Genesis Clinical Research

    RECRUITING

    Tampa, Florida, 33603, United States

  • Orlando Clinical Research Center

    RECRUITING

    Orlando, Florida, 32809, United States

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