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New drug HU6 targets fatty liver disease in Mid-Stage trial

NCT ID NCT07491458

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a new drug called HU6 for people with MASH, a serious fatty liver disease. About 180 adults aged 30 and older will receive either HU6 or a placebo to see if the drug safely reduces liver fat. The trial lasts 26 weeks and focuses on safety and how well the drug works.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 180 people

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

Started

Feb 2026

Expected to finish

Feb 2028

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

30 years and older

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: * Male and female ≥30 years of age at time of signing the informed consent. * Diagnosed with metabolic dysfunction-associated steatohepatitis (MASH) * Women of childbearing potential must not be pregnant or breastfeeding and must use and agree to continue to use a highly effective contraceptive method throughout time on study. * Body Mass Index (BMI) ≥27.0 kg/m2 to ≤44 kg/m2 Exclusion Criteria: * Have acute or chronic hepatitis, signs, and symptoms of any other liver disease (eg, Wilson's disease) other than MASH * Cholecystectomy or any other surgical or medical condition or history that may potentially alter the absorption, metabolism, or excretion of study treatment. * History (including any family history) of malignant hyperthermia. * History of malignancy within 5 years (except cutaneous basal or squamous cell carcinoma, carcinoma-in-situ, or low-grade prostate cancer). * History of the following cardiovascular conditions within 3 months prior to randomization: acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, hospitalization due to congestive heart failure (CHF), or acute CHF. * Significant and unstable lung disease (chronic obstructive pulmonary disease \[COPD\], emphysema, pulmonary fibrosis, or asthma) requiring oxygen or chronic daily medication. Note that mild, stable COPD and asthma on inhalers are allowed. * Monogenetic diabetes or type 1 diabetes. * History of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to Screening. * History of agranulocytosis. * History of or active evidence of ophthalmological conditions * Untreated, uncontrolled, or unstable hypertension * Use of any of the following medications/therapies: Vitamin E: use of ursodiol or high-dose vitamin E (\>400 IU/day) for a duration of \>1 month within 6 months or started high dose vitamin E for any duration within 3 months prior to screening * Within 3 months prior to screening or plan to use prior to coming off study drug: resmetirom (Rezdiffra®), GLP 1 agonists and gastric inhibitory polypeptide (GIP)/GLP-1 agonists, Weight loss medications/therapies including: herbal preparation, over the counter (OTC) drug, mail order or prescription drug, Oral antidiabetic medications/therapies including: insulin, meglitinides, thiazolidinediones. Prescription or OTC stimulants. Recent or current use of obeticholic acid (Ocaliva®), systemic corticosteroids, methotrexate, tamoxifen, amiodarone, or long-term use of tetracyclines. Warfarin, heparin, factor Xa inhibitors due to risk of bleeding, Medications with high risk of idiosyncratic drug-induced neutropenia (IDIN) or agranulocytosis. * History of hepatitis or human immunodeficiency virus (HIV1 \& HIV2) * Intolerance to MRI or with conditions contraindicated for MRI procedures * Participation in another clinical trial at the time of screening or exposure to any investigational product, including topical agents, within 28 days prior to starting study treatment * Additional inclusion/exclusion criteria could apply

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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.

Mash - metabolic dysfunction-associated steatohepatitis

How to take part

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

  1. The places running it

    31 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

  • Arizona Liver Health - Chandler

    RECRUITING

    Chandler, Arizona, 85224, United States

  • Arizona Liver Health - Peoria

    RECRUITING

    Peoria, Arizona, 85381, United States

  • Arizona Liver Health - Tucson

    RECRUITING

    Tucson, Arizona, 85712, United States

  • Baptist Health Center for Clinical Research

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • Bellaire Clinical Research, LLC

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Catalina Research Institute

    RECRUITING

    Montclair, California, 91763, United States

  • Charter Research LLC - Chicago

    RECRUITING

    Chicago, Illinois, 60618, United States

  • Charter Research LLC - Orlando

    RECRUITING

    Orlando, Florida, 32803, United States

  • Clinical Research Institute of Michigan

    RECRUITING

    Clinton Township, Michigan, 48038, United States

  • Clinical Research Institute of Ohio, LLC (CRIOH)

    RECRUITING

    Westlake, Ohio, 44145, United States

  • Coastal Research Institute

    RECRUITING

    Fayetteville, North Carolina, 28304, United States

  • Delta Research Partners of Bastrop, LLC

    RECRUITING

    Bastrop, Louisiana, 71220, United States

  • Delta Research Partners of West Monroe, LLC

    RECRUITING

    West Monroe, Louisiana, 71291, United States

  • HRI - Medical Center, LLC

    RECRUITING

    Houston, Texas, 77030, United States

  • HRI - Pasadena, LLC

    RECRUITING

    Pasadena, Texas, 77505, United States

  • HRI - Sugarland, LLC

    RECRUITING

    Sugar Land, Texas, 77478, United States

  • Houston Research Institute

    RECRUITING

    Houston, Texas, 77079, United States

  • IMA Clinical Research (Austin)

    RECRUITING

    Austin, Texas, 78745, United States

  • Innovative Clinical Research, LLC

    RECRUITING

    Clarksville, Tennessee, 37040, United States

  • Jubilee Clinical Research, LLC.

    RECRUITING

    Las Vegas, Nevada, 89106, United States

  • KAD Clinical Research

    RECRUITING

    St Louis, Missouri, 63123, United States

  • Kansas City Research Institute

    RECRUITING

    Kansas City, Missouri, 64131, United States

  • Knowledge Research Center

    RECRUITING

    Orange, California, 92868, United States

  • National Institute of Clinical Research

    RECRUITING

    Garden Grove, California, 92844, United States

  • Nucleus Network Minneapolis

    RECRUITING

    Saint Paul, Minnesota, 55114, United States

  • Pinnacle Clinical Research - Austin

    RECRUITING

    Austin, Texas, 78757, United States

  • Pinnacle Clinical Research - Corpus Christi

    RECRUITING

    Corpus Christi, Texas, 78404, United States

  • Pinnacle Clinical Research - Georgetown

    RECRUITING

    Georgetown, Texas, 78626, United States

  • Pinnacle Clinical Research - San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Quality Research

    RECRUITING

    San Antonio, Texas, 78209, United States

  • Tekton Research - Yukon

    RECRUITING

    Yukon, Oklahoma, 73099, United States

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