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A Trial to Investigate Safety, Exposure, and Efficacy of HU6 Compared With Placebo in Adult Participants With Metabolic Dysfunction-associated Steatohepatitis (MASH)
A Parallel Treatment Group, Phase 2a, Double-blind, 4-arm Trial to Evaluate the Safety, Exposure, and Efficacy of HU6 Compared With Placebo in Male and Female Participants Aged 30 Years or Older With Metabolic Dysfunction-associated Steatohepatitis (MASH)
Who can join
Ages 30 and older · All sexes
Full eligibility criteria
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
About the study
Rivus Pharmaceuticals. Inc. is sponsoring this research study to assess the safety and tolerability of HU6 as a possible treatment for patients diagnosed with metabolic dysfunction-associated steatohepatitis (MASH). The study will also assess safety, pharmacokinetics (PK) and changes in liver fat content related to patients diagnosed with MASH.
What is being tested
- HU6 (drug)
- Placebo (other)
Sponsor: Rivus Pharmaceuticals, Inc. · Participants: 180 · Started: Feb 13, 2026
Contact the study team
- Clinical Operations Lead · Phone: 6173887757
- VP, Clinical Operations · Phone: 8435683621
Official record on ClinicalTrials.gov — NCT07491458
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.