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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)

RecruitingPhase 2

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

Sponsor: Rivus Pharmaceuticals, Inc. · Participants: 180 · Started: Feb 13, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07491458

Locations in the U.S.

ArizonaArizona Liver Health - Chandler, Chandler
Arizona Liver Health - Peoria, Peoria
Arizona Liver Health - Tucson, Tucson
ArkansasBaptist Health Center for Clinical Research, Little Rock
CaliforniaNational Institute of Clinical Research, Garden Grove
Catalina Research Institute, Montclair
Knowledge Research Center, Orange
FloridaCharter Research LLC - Orlando, Orlando
IllinoisCharter Research LLC - Chicago, Chicago
LouisianaDelta Research Partners of Bastrop, LLC, Bastrop
Delta Research Partners of West Monroe, LLC, West Monroe
MichiganClinical Research Institute of Michigan, Clinton Township
MinnesotaNucleus Network Minneapolis, Saint Paul
MissouriKansas City Research Institute, Kansas City
KAD Clinical Research, St Louis
NevadaJubilee Clinical Research, LLC., Las Vegas
North CarolinaCoastal Research Institute, Fayetteville
OhioClinical Research Institute of Ohio, LLC (CRIOH), Westlake
OklahomaTekton Research - Yukon, Yukon
TennesseeInnovative Clinical Research, LLC, Clarksville
TexasIMA Clinical Research (Austin), Austin
Pinnacle Clinical Research - Austin, Austin
Bellaire Clinical Research, LLC, Bellaire
Pinnacle Clinical Research - Corpus Christi, Corpus Christi
Pinnacle Clinical Research - Georgetown, Georgetown
HRI - Medical Center, LLC, Houston
Houston Research Institute, Houston
HRI - Pasadena, LLC, Pasadena
Pinnacle Clinical Research - San Antonio, San Antonio
Quality Research, San Antonio
HRI - Sugarland, LLC, Sugar Land

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.