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HU6 for Metabolic Dysfunction-associated Steatohepatitis (MASH)

This study is testing a new drug called HU6 for adults with Metabolic Dysfunction-associated Steatohepatitis (MASH), a type of liver disease. Researchers want to see if HU6 is safe and how much of it stays in your body. They will also measure changes in liver fat using a special MRI scan. You might be able to join if you are at least 30 years old, have MASH, and a Body Mass Index (BMI) of 27 or higher. The study will compare HU6 to a placebo (an inactive substance) to understand its effects. The main goals are to track any side effects and see if HU6 can reduce liver fat over 26 weeks.

Study design
This is a randomized, double-blind, placebo-controlled study with an open-label extension, planning to enroll 180 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a safety follow-up visit and two long-term follow-up visits after the main treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07491458

A Trial to Investigate Safety, Exposure, and Efficacy of HU6 Compared With Placebo in Adult Participants With Metabolic Dysfunction-associated Steatohepatitis (MASH)

Recruiting
PHASE2Ages 30+InterventionalTreatment
Rivus Pharmaceuticals, Inc.
~180 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:HU6Placebo

At a glance

Recruiting sites
31 of 31 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number and Percentage of Adverse Events (AEs)
Measured over 26 weeks
+9 more outcomes measured

Conditions

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Explore related trials

Nonalcoholic Steatohepatitis

NCT07491458

Where you'd take part

This study runs at 31 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Arizona Liver Health - Chandler

    Chandler, Arizonastudy coordinator listed

    Recruiting

  • Arizona Liver Health - Peoria

    Peoria, Arizonastudy coordinator listed

    Recruiting

  • Arizona Liver Health - Tucson

    Tucson, Arizonastudy coordinator listed

    Recruiting

  • Baptist Health Center for Clinical Research

    Little Rock, Arkansasstudy coordinator listed

    Recruiting

  • Bellaire Clinical Research, LLC

    Bellaire, Texasstudy coordinator listed

    Recruiting

  • Catalina Research Institute

    Montclair, Californiastudy coordinator listed

    Recruiting

  • Charter Research LLC - Chicago

    Chicago, Illinoisstudy coordinator listed

    Recruiting

  • Charter Research LLC - Orlando

    Orlando, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Stefanie Mason, MD · STUDY_DIRECTOR · Rivus Pharmaceuticals, Inc.

Who to contact

Clinical Operations Lead
[email protected]
6173887757
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number and Percentage of Adverse Events (AEs)26 weeks
  • Percent change from baseline to Week 26 In Liver Fat Assessed by MRI-PDFF26 weeks
  • Percentage of participants with Liver Fat reduction by ≥30% Assessed by MRI-PDFF26 weeks
  • Area Under the Plasma Concentration-Time Curve (AUC)26 weeks
  • Trough Plasma Concentration (Ctrough)26 weeks
  • Maximum Observed Plasma Concentration (Cmax)26 weeks
  • Time to Maximum Plasma Concentration (Tmax)26 weeks
  • Plasma Clearance of drug after extravascular administration (CL/F)26 weeks
  • Volume of distribution after extravascular administration (V/F)26 weeks
  • Drug elimination half-life (t½)26 weeks