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RecruitingPhase 2

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. · NCT07491458

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 30+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
180
US sites recruiting
31
Study start
February 13, 2026
Record last updated
May 18, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: HU6; Placebo

Conditions: MASH - Metabolic Dysfunction-Associated Steatohepatitis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Arizona Liver Health - Chandler

    Chandler, AZ 85224

    Site contact: Enrique Topete · 480-470-4000 · etopete@azclinicaltrials.com

  • Arizona Liver Health - Peoria

    Peoria, AZ 85381

    Site contact: Ann Moore · 480-470-4000 · amoore@azliver.com

  • Arizona Liver Health - Tucson

    Tucson, AZ 85712

    Site contact: Vivian Martinez · 520-485-4000 · vmartinez@azliver.com

  • Baptist Health Center for Clinical Research

    Little Rock, AR 72205

    Site contact: Karen Willis · 501-224-1348 · kmwillis@bhccr.com

  • National Institute of Clinical Research

    Garden Grove, CA 92844

    Site contact: Ryan Dudley · 323-725-0657 · rdudley@nicresearch.com

  • Catalina Research Institute

    Montclair, CA 91763

    Site contact: Michael Gallardo · 909-590-8409 · michael.gallardo@elixiahealth.com

  • Knowledge Research Center

    Orange, CA 92868

    Site contact: Aleesha Browning · 657-247-0087 · abrowning@krcorange.com

  • Charter Research LLC - Orlando

    Orlando, FL 32803

    Site contact: Valeria Robles · 407-337-3000 · valeria.robles@charterresearch.com

  • Charter Research LLC - Chicago

    Chicago, IL 60618

    Site contact: Teresa Kalowsky · 773-997-1000 · Teresa.Kalowsky@charterresearch.com

  • Delta Research Partners of Bastrop, LLC

    Bastrop, LA 71220

    Site contact: Casey Petrus · 904-854-1354 · casey.petrus@roviaclinical.com

  • Delta Research Partners of West Monroe, LLC

    West Monroe, LA 71291

    Site contact: Jennifer Davidson · 904-854-1354 · jennifer.davidson@roviaclinical.com

  • Clinical Research Institute of Michigan

    Clinton Township, MI 48038

    Site contact: Karie Simmons · 586-598-3329 · ksimons@researchmi.com

  • Nucleus Network Minneapolis

    Saint Paul, MN 55114

    Site contact: Kate Tilley · 651-641-2900 · k.tilley@nucleusnetwork.com

  • Kansas City Research Institute

    Kansas City, MO 64131

    Site contact: Taleah Brown · 816-759-5274 · tbrown@kcri.health

  • KAD Clinical Research

    St Louis, MO 63123

    Site contact: Kristina Wriston · 314-254-3168 · kwriston@kadclinicalresearch.com

  • Jubilee Clinical Research, LLC.

    Las Vegas, NV 89106

    Site contact: Julie Gass · 702-631-5000 · jgass@jcr-lv.com

  • Coastal Research Institute

    Fayetteville, NC 28304

    Site contact: Jessica Maples · 910-500-3146 · jmaples@coastalresearchnc.com

  • Clinical Research Institute of Ohio, LLC (CRIOH)

    Westlake, OH 44145

    Site contact: Mousab Tabbaac · 440-363-4000 · MTabbaa@ohioresearch.com

  • Tekton Research - Yukon

    Yukon, OK 73099

    Site contact: Laura Fumero · 855-380-2822 · lfumero@evotrials.com

  • Innovative Clinical Research, LLC

    Clarksville, TN 37040

    Site contact: Mary Kosinski · 847-469-6971 · mkosinski@ICRresearch.com

  • IMA Clinical Research (Austin)

    Austin, TX 78745

    Site contact: Kate Banks · 512-649-0082 · kate.banks@imaresearch.com

  • Pinnacle Clinical Research - Austin

    Austin, TX 78757

    Site contact: Maria Macias · 512-384-1560 · mmacias@pinnacleresearch.com

  • Bellaire Clinical Research, LLC

    Bellaire, TX 77401

    Site contact: Layla Haider · 844-399-0449 · lhaidar@pinnacleresearch.com

  • Pinnacle Clinical Research - Corpus Christi

    Corpus Christi, TX 78404

    Site contact: Ashley Giron · 361-400-5352 · agiron@pinnacleresearch.com

  • Pinnacle Clinical Research - Georgetown

    Georgetown, TX 78626

    Site contact: Nirupama Jerome · 737-444-8408 · njerome@pinnacleresearch.com

  • HRI - Medical Center, LLC

    Houston, TX 77030

    Site contact: Callie Pettigrew · 713-794-0700 · cpettigrew@houstonresearchinstitute.com

  • Houston Research Institute

    Houston, TX 77079

    Site contact: Evelyn Gonzalez · 281-809-3234 · egonzalez1@pinnacleresearch.com

  • HRI - Pasadena, LLC

    Pasadena, TX 77505

    Site contact: Layla Haidar · 281-809-3234 · lhaidar@pinnacleresearch.com

  • Quality Research

    San Antonio, TX 78209

    Site contact: Chelsie Lopez · 210-864-8844 · c.lopez@qualityresearch.com

  • Pinnacle Clinical Research - San Antonio

    San Antonio, TX 78229

    Site contact: Mary Lou Hernandez · 210-982-0320 · mhernandez@pinnacleresearch.com

  • HRI - Sugarland, LLC

    Sugar Land, TX 77478

    Site contact: Tania Deras · 281-809-3234 · tderas@houstonresearchinstitute.com

Study contacts (from the official record)

  • Clinical Operations Lead · 6173887757 · jsoto@rivuspharma.com
  • VP, Clinical Operations · 8435683621 · jdurden@rivuspharma.com
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A Trial to Investigate Safety, Exposure, and Efficacy of HU6… (NCT07491458) | Bored Studies