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Can a weekly shot reverse liver damage from fatty liver disease?

NCT ID NCT07795164

Disease control Sponsor: Altimmune, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether pemvidutide, an injected drug, can improve liver health in people with MASH, a condition where fat builds up in the liver and causes inflammation and scarring. The study enrolls about 1,800 adults with moderate liver scarring who do not have cirrhosis. Researchers measure whether the drug leads to resolution of MASH, improves fibrosis, and delays serious liver events like cirrhosis or liver failure.

What this could mean

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

Active substance
pemvidutide, an investigational drug given by injection
What this could lead to
If it works, pemvidutide could become a treatment that reverses liver scarring and lowers the risk of cirrhosis, liver failure, or liver cancer in people with MASH.
What could go wrong
This is a large, late-stage trial, but success is not guaranteed. The drug may not outperform placebo, and side effects from the injection could limit its use.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,800 people

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

Started

Jul 2026

Expected to finish

Dec 2032

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 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 subjects: * No significant changes in body weight (±5%) and not participating in a structured weight loss program for the 3 months prior to screening (or since the historical biopsy, if applicable) * Body mass index (BMI) ≥ 25.0 kg/m2; if Asian, BMI ≥ 23.0 kg/m2 * Type 2 diabetes (T2D) or at least 2 components of metabolic syndrome * Subject agrees to have liver biopsy(ies) as required per protocol Cohort 1 - Histologic diagnosis of F2/F3 MASH based on liver biopsy during screening or historical biopsy within 6 months before screening Cohort 2 - Presumed F2/F3 MASH based on noninvasive testing Exclusion Criteria: * Cirrhosis (F4); portal hypertension or hepatic decompensation; acute or chronic liver disease other than MASH; liver function tests (ALT, AST; alkaline phosphatase; total bilirubin; INR; and platelet count) outside of acceptable ranges; positive HBsAg; active hepatitis C * Uncontrolled T2D or clinically significant persistent hyperglycemia

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatohepatitis

As listed by the trial registrant

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

Metabolic dysfunction-associated steatohepatitis(MASH)

How to take part

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

  1. The places running it

    9 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

  • Altimmune Clinical Study Site

    RECRUITING

    North Little Rock, Arkansas, 72117, United States

  • Altimmune Clinical Study Site

    RECRUITING

    Fountain Valley, California, 92708, United States

  • Altimmune Clinical Study Site

    RECRUITING

    Fresno, California, 93720, United States

  • Altimmune Clinical Study Site

    RECRUITING

    Gardena, California, 90247, United States

  • Altimmune Clinical Study Site

    RECRUITING

    Long Beach, California, 90815, United States

  • Altimmune Clinical Study Site

    RECRUITING

    Miami, Florida, 33173, United States

  • Altimmune Clinical Study Site

    RECRUITING

    Ocala, Florida, 34471, United States

  • Altimmune Clinical Study Site

    RECRUITING

    Springboro, Ohio, 45066, United States

  • Altimmune Clinical Study Site

    RECRUITING

    Westlake, Ohio, 44145, United States

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