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HU6 compared with placebo for adults with 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)

Phase 2 Interventional Rivus Pharmaceuticals, Inc. · NCT07491458

This study tests whether HU6 is safe and can reduce liver fat in adults with metabolic dysfunction-associated steatohepatitis (MASH).

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment180 (estimated)
Ages30 Years and up
SexAll
SponsorRivus Pharmaceuticals, Inc. Industry-sponsored
Drugs / interventionsmethotrexate
Locations33 sites (Chandler, Arizona and 32 other locations)
Trial IDNCT07491458 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled, multicenter Phase 2 trial with a two-part design that includes a blinded intervention period and an optional open-label extension for those who complete the blinded period. The trial compares HU6 to placebo and monitors safety, pharmacokinetics, and changes in liver fat and other MASH-related measures. Participants undergo screening, a blinded treatment phase, an end-of-treatment visit (or early termination), a safety follow-up, and two long-term follow-up visits. The multicenter conduct is limited to three clinical sites in Arizona.

Who should consider this trial

Good fit: Adults aged 30 years or older with a diagnosis of MASH and a BMI between 27.0 and 44.0 kg/m2 who meet contraception and other study requirements are the intended participants.

Not a fit: People with other liver diseases, recent major cardiovascular events, a recent history of malignancy, prior cholecystectomy or other conditions that alter drug absorption/metabolism, or other listed exclusions are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, HU6 could reduce liver fat and improve liver-related outcomes, offering a new treatment option for adults with MASH.

How similar studies have performed: Other investigational agents targeting liver fat and inflammation have shown promising Phase 2 results, but HU6 is a novel compound with limited prior clinical data.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Chandler, Arizona and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions MASH - Metabolic Dysfunction-Associated Steatohepatitis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.