Recruiting

Phase 2

HU6A Trial to Investigate Safety, Exposure, and Efficacy of HU6 Compared With Placebo in Adult Participants With Metabolic Dysfunction-associated Steatohepatitis (MASH)

Sponsor:

Rivus Pharmaceuticals, Inc.

Code:

NCT07491458

Conditions

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Interventions

HU6

Placebo

Study Details

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

Study ID

NCT07491458

Start date

Feb 13, 2026

Status verified date

May, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HU6 450 mg

450 mg Once Daily (QD)

experimental: HU6 300 mg

300 mg Twice Daily (BID)

placebo comparator: Placebo Once Daily

Placebo Once Daily (QD)

placebo comparator: Placebo Twice Daily

Placebo Twice Daily (BID)

Interventions

HU6

HU6 is being evaluated for efficacy in MASH

Placebo

Placebo comparator

Primary outcome measure

Number and Percentage of Adverse Events (AEs) [ Time Frame: 26 weeks ]
Percent change from baseline to Week 26 In Liver Fat Assessed by MRI-PDFF [ Time Frame: 26 weeks ]
Percentage of participants with Liver Fat reduction by ≥30% Assessed by MRI-PDFF [ Time Frame: 26 weeks ]
Area Under the Plasma Concentration-Time Curve (AUC) [ Time Frame: 26 weeks ]
Trough Plasma Concentration (Ctrough) [ Time Frame: 26 weeks ]
Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 26 weeks ]
Time to Maximum Plasma Concentration (Tmax) [ Time Frame: 26 weeks ]
Plasma Clearance of drug after extravascular administration (CL/F) [ Time Frame: 26 weeks ]
Volume of distribution after extravascular administration (V/F) [ Time Frame: 26 weeks ]
Drug elimination half-life (t½) [ Time Frame: 26 weeks ]

Central Contacts and Locations

Central contacts

Clinical Operations Lead

6173887757 jsoto@rivuspharma.com

VP, Clinical Operations

8435683621 jdurden@rivuspharma.com

Locations

Arizona Liver Health - Chandler

Recruiting

Chandler, Arizona, United States, 85224

Contacts

Enrique Topete

480-470-4000 etopete@azclinicaltrials.com

Arizona Liver Health - Peoria

Recruiting

Peoria, Arizona, United States, 85381

Contacts

Ann Moore

480-470-4000 amoore@azliver.com

Arizona Liver Health - Tucson

Recruiting

Tucson, Arizona, United States, 85712

Contacts

Vivian Martinez

520-485-4000 vmartinez@azliver.com

Baptist Health Center for Clinical Research

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Karen Willis

501-224-1348 kmwillis@bhccr.com

National Institute of Clinical Research

Recruiting

Garden Grove, California, United States, 92844

Contacts

Ryan Dudley

323-725-0657 rdudley@nicresearch.com

Principal Investigator:

Michael Dao, MD

Catalina Research Institute

Recruiting

Montclair, California, United States, 91763

Contacts

Michael Gallardo

909-590-8409 michael.gallardo@elixiahealth.com

Principal Investigator:

Rizwana Mohseni, MD

Knowledge Research Center

Recruiting

Orange, California, United States, 92868

Contacts

Aleesha Browning

657-247-0087 abrowning@krcorange.com

Principal Investigator:

Alaa Abousaif, MD

Charter Research LLC - Orlando

Recruiting

Orlando, Florida, United States, 32803

Contacts

Valeria Robles

407-337-3000 valeria.robles@charterresearch.com

Charter Research LLC - Chicago

Recruiting

Chicago, Illinois, United States, 60618

Contacts

Teresa Kalowsky

773-997-1000 Teresa.Kalowsky@charterresearch.com

Delta Research Partners of Bastrop, LLC

Recruiting

Bastrop, Louisiana, United States, 71220

Contacts

Casey Petrus

904-854-1354 casey.petrus@roviaclinical.com

Delta Research Partners of West Monroe, LLC

Recruiting

West Monroe, Louisiana, United States, 71291

Contacts

Jennifer Davidson

904-854-1354 jennifer.davidson@roviaclinical.com

Clinical Research Institute of Michigan

Recruiting

Clinton Township, Michigan, United States, 48038

Contacts

Karie Simmons

586-598-3329 ksimons@researchmi.com

Principal Investigator:

Ronald Fogel, MD

Nucleus Network Minneapolis

Recruiting

Saint Paul, Minnesota, United States, 55114

Contacts

Kate Tilley

651-641-2900 k.tilley@nucleusnetwork.com

Principal Investigator:

Trish Shamp, PhD

Kansas City Research Institute

Recruiting

Kansas City, Missouri, United States, 64131

Contacts

Taleah Brown

816-759-5274 tbrown@kcri.health

KAD Clinical Research

Recruiting

St Louis, Missouri, United States, 63123

Contacts

Kristina Wriston

314-254-3168 kwriston@kadclinicalresearch.com

Jubilee Clinical Research, LLC.

Recruiting

Las Vegas, Nevada, United States, 89106

Contacts

Julie Gass

702-631-5000 jgass@jcr-lv.com

Coastal Research Institute

Recruiting

Fayetteville, North Carolina, United States, 28304

Contacts

Jessica Maples

910-500-3146 jmaples@coastalresearchnc.com

Clinical Research Institute of Ohio, LLC (CRIOH)

Recruiting

Westlake, Ohio, United States, 44145

Contacts

Mousab Tabbaac

440-363-4000 MTabbaa@ohioresearch.com

Tekton Research - Yukon

Recruiting

Yukon, Oklahoma, United States, 73099

Contacts

Laura Fumero

855-380-2822 lfumero@evotrials.com

Innovative Clinical Research, LLC

Recruiting

Clarksville, Tennessee, United States, 37040

Contacts

Mary Kosinski

847-469-6971 mkosinski@ICRresearch.com

IMA Clinical Research (Austin)

Recruiting

Austin, Texas, United States, 78745

Contacts

Kate Banks

512-649-0082 kate.banks@imaresearch.com

Pinnacle Clinical Research - Austin

Recruiting

Austin, Texas, United States, 78757

Contacts

Maria Macias

512-384-1560 mmacias@pinnacleresearch.com

Bellaire Clinical Research, LLC

Recruiting

Bellaire, Texas, United States, 77401

Contacts

Layla Haider

844-399-0449 lhaidar@pinnacleresearch.com

Pinnacle Clinical Research - Corpus Christi

Recruiting

Corpus Christi, Texas, United States, 78404

Contacts

Ashley Giron

361-400-5352 agiron@pinnacleresearch.com

Pinnacle Clinical Research - Georgetown

Recruiting

Georgetown, Texas, United States, 78626

Contacts

Nirupama Jerome

737-444-8408 njerome@pinnacleresearch.com

HRI - Medical Center, LLC

Recruiting

Houston, Texas, United States, 77030

Contacts

Callie Pettigrew

713-794-0700 cpettigrew@houstonresearchinstitute.com

Houston Research Institute

Recruiting

Houston, Texas, United States, 77079

Contacts

Evelyn Gonzalez

281-809-3234 egonzalez1@pinnacleresearch.com

HRI - Pasadena, LLC

Recruiting

Pasadena, Texas, United States, 77505

Contacts

Layla Haidar

281-809-3234 lhaidar@pinnacleresearch.com

Quality Research

Recruiting

San Antonio, Texas, United States, 78209

Contacts

Chelsie Lopez

210-864-8844 c.lopez@qualityresearch.com

Principal Investigator:

Robert Morin, MD

Pinnacle Clinical Research - San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Mary Lou Hernandez

210-982-0320 mhernandez@pinnacleresearch.com

HRI - Sugarland, LLC

Recruiting

Sugar Land, Texas, United States, 77478

Contacts

Tania Deras

281-809-3234 tderas@houstonresearchinstitute.com

More Information

Sponsor

Rivus Pharmaceuticals, Inc.

Last update posted

May 18, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by Rivus Pharmaceuticals, Inc. on 2026-05-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.