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NCT07491458PHASE2Recruiting

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

Rivus Pharmaceuticals, Inc.

Start Date

2/13/2026

Completion Date

2/1/2028

Summary

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.

Detailed Description

This is a 2-part randomized, double-blind, placebo-controlled, multicenter trial with an open label extension (OLE) to evaluate the safety and exposure of HU6 as well as the effect of HU6 on liver fat and other symptoms associated with MASH. The 2-part trial design consists of a blinded intervention period and, for participants who completed the blinded intervention period, an option to continue in an OLE intervention period. The blinded trial design consists of a screening period, a blinded intervention period, an end of treatment (EOT)/early termination (ET) visit, a safety follow-up visit, and two long-term follow up visits.

Eligibility Criteria

Age Range: 30 years to No maximum

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

Interventions

DRUG

HU6

OTHER

Placebo

Interested in This Trial?

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Conditions

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Locations

Arizona Liver Health - Chandler

Chandler, Arizona 85224

United States

Arizona Liver Health - Peoria

Peoria, Arizona 85381

United States

Arizona Liver Health - Tucson

Tucson, Arizona 85712

United States

Baptist Health Center for Clinical Research

Little Rock, Arkansas 72205

United States

National Institute of Clinical Research

Garden Grove, California 92844

United States

Catalina Research Institute

Montclair, California 91763

United States

Knowledge Research Center

Orange, California 92868

United States

Charter Research LLC - Orlando

Orlando, Florida 32803

United States

Charter Research LLC - Chicago

Chicago, Illinois 60618

United States

Delta Research Partners of Bastrop, LLC

Bastrop, Louisiana 71220

United States

Delta Research Partners of West Monroe, LLC

West Monroe, Louisiana 71291

United States

Clinical Research Institute of Michigan

Clinton Township, Michigan 48038

United States

Nucleus Network Minneapolis

Saint Paul, Minnesota 55114

United States

Kansas City Research Institute

Kansas City, Missouri 64131

United States

KAD Clinical Research

St Louis, Missouri 63123

United States

Jubilee Clinical Research, LLC.

Las Vegas, Nevada 89106

United States

Coastal Research Institute

Fayetteville, North Carolina 28304

United States

Clinical Research Institute of Ohio, LLC (CRIOH)

Westlake, Ohio 44145

United States

Tekton Research - Yukon

Yukon, Oklahoma 73099

United States

Innovative Clinical Research, LLC

Clarksville, Tennessee 37040

United States

IMA Clinical Research (Austin)

Austin, Texas 78745

United States

Pinnacle Clinical Research - Austin

Austin, Texas 78757

United States

Bellaire Clinical Research, LLC

Bellaire, Texas 77401

United States

Pinnacle Clinical Research - Corpus Christi

Corpus Christi, Texas 78404

United States

Pinnacle Clinical Research - Georgetown

Georgetown, Texas 78626

United States

HRI - Medical Center, LLC

Houston, Texas 77030

United States

Houston Research Institute

Houston, Texas 77079

United States

HRI - Pasadena, LLC

Pasadena, Texas 77505

United States

Quality Research

San Antonio, Texas 78209

United States

Pinnacle Clinical Research - San Antonio

San Antonio, Texas 78229

United States

HRI - Sugarland, LLC

Sugar Land, Texas 77478

United States