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

NCT07491458 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: RIV-HU6-2204
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 31

Brief 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.

Conditions

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Outcome Measures

Primary Outcomes (10)

• Number and Percentage of Adverse Events (AEs)

  26 weeks

• Percent change from baseline to Week 26 In Liver Fat Assessed by MRI-PDFF

  26 weeks

• Percentage of participants with Liver Fat reduction by ≥30% Assessed by MRI-PDFF

  26 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

Study Arms (4)

HU6 450 mg

EXPERIMENTAL

450 mg Once Daily (QD)

Drug: HU6

HU6 300 mg

EXPERIMENTAL

300 mg Twice Daily (BID)

Drug: HU6

Placebo Once Daily

PLACEBO COMPARATOR

Placebo Once Daily (QD)

Other: Placebo

Placebo Twice Daily

PLACEBO COMPARATOR

Placebo Twice Daily (BID)

Other: Placebo

Interventions

HU6 DRUG

HU6 is being evaluated for efficacy in MASH

HU6 300 mg; HU6 450 mg

Placebo OTHER

Placebo comparator

Placebo Once Daily; Placebo Twice Daily

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rivus Pharmaceuticals, Inc.: lead

Study Sites (31)

Arizona Liver Health - Chandler

Chandler, Arizona, 85224, United States

RECRUITING

Arizona Liver Health - Peoria

Peoria, Arizona, 85381, United States

RECRUITING

Arizona Liver Health - Tucson

Tucson, Arizona, 85712, United States

RECRUITING

Baptist Health Center for Clinical Research

Little Rock, Arkansas, 72205, United States

RECRUITING

National Institute of Clinical Research

Garden Grove, California, 92844, United States

RECRUITING

Catalina Research Institute

Montclair, California, 91763, United States

RECRUITING

Knowledge Research Center

Orange, California, 92868, United States

RECRUITING

Charter Research LLC - Orlando

Orlando, Florida, 32803, United States

RECRUITING

Charter Research LLC - Chicago

Chicago, Illinois, 60618, United States

RECRUITING

Delta Research Partners of Bastrop, LLC

Bastrop, Louisiana, 71220, United States

RECRUITING

Delta Research Partners of West Monroe, LLC

West Monroe, Louisiana, 71291, United States

RECRUITING

Clinical Research Institute of Michigan

Clinton Township, Michigan, 48038, United States

RECRUITING

Nucleus Network Minneapolis

Saint Paul, Minnesota, 55114, United States

RECRUITING

Kansas City Research Institute

Kansas City, Missouri, 64131, United States

RECRUITING

KAD Clinical Research

St Louis, Missouri, 63123, United States

RECRUITING

Jubilee Clinical Research, LLC.

Las Vegas, Nevada, 89106, United States

RECRUITING

Coastal Research Institute

Fayetteville, North Carolina, 28304, United States

RECRUITING

Clinical Research Institute of Ohio, LLC (CRIOH)

Westlake, Ohio, 44145, United States

RECRUITING

Tekton Research - Yukon

Yukon, Oklahoma, 73099, United States

RECRUITING

Innovative Clinical Research, LLC

Clarksville, Tennessee, 37040, United States

RECRUITING

IMA Clinical Research (Austin)

Austin, Texas, 78745, United States

RECRUITING

Pinnacle Clinical Research - Austin

Austin, Texas, 78757, United States

RECRUITING

Bellaire Clinical Research, LLC

Bellaire, Texas, 77401, United States

RECRUITING

Pinnacle Clinical Research - Corpus Christi

Corpus Christi, Texas, 78404, United States

RECRUITING

Pinnacle Clinical Research - Georgetown

Georgetown, Texas, 78626, United States

RECRUITING

HRI - Medical Center, LLC

Houston, Texas, 77030, United States

RECRUITING

Houston Research Institute

Houston, Texas, 77079, United States

RECRUITING

HRI - Pasadena, LLC

Pasadena, Texas, 77505, United States

RECRUITING

Quality Research

San Antonio, Texas, 78209, United States

RECRUITING

Pinnacle Clinical Research - San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

HRI - Sugarland, LLC

Sugar Land, Texas, 77478, United States

RECRUITING

Study Officials

• Stefanie Mason, MD

  Rivus Pharmaceuticals, Inc.

  STUDY DIRECTOR

Central Study Contacts

Clinical Operations Lead

CONTACT

6173887757; jsoto@rivuspharma.com

VP, Clinical Operations

CONTACT

8435683621; jdurden@rivuspharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 24, 2026
• Study Start: February 13, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

US (31)