HU6 compared with placebo for adults with MASH

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Arizona Liver Health - Chandler
  Chandler, Arizona, United States Recruiting
• Arizona Liver Health - Peoria
  Peoria, Arizona, United States Recruiting
• Arizona Liver Health - Tucson
  Tucson, Arizona, United States Recruiting
• Baptist Health Center for Clinical Research
  Little Rock, Arkansas, United States Recruiting
• National Institute of Clinical Research
  Garden Grove, California, United States Recruiting
• Catalina Research Institute
  Montclair, California, United States Recruiting

Study contacts

• Study coordinator: Clinical Operations Lead
• Email: jsoto@rivuspharma.com
• Phone: 6173887757

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• HSK31679 in MASH: a phase 3 test for safety and liver improvement

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.