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

May 14, 2026 updated by: Rivus Pharmaceuticals, Inc.

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a 2-part randomized, double-blind, placebo-controlled, multicenter trial with an open label extension (OLE) to evaluate the safety and exposure of HU6 as well as the effect of HU6 on liver fat and other symptoms associated with MASH.

The 2-part trial design consists of a blinded intervention period and, for participants who completed the blinded intervention period, an option to continue in an OLE intervention period. The blinded trial design consists of a screening period, a blinded intervention period, an end of treatment (EOT)/early termination (ET) visit, a safety follow-up visit, and two long-term follow up visits.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
      • Peoria, Arizona, United States, 85381
        • Recruiting
        • Arizona Liver Health - Peoria
        • Contact:
      • Tucson, Arizona, United States, 85712
        • Recruiting
        • Arizona Liver Health - Tucson
        • Contact:
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • Baptist Health Center For Clinical Research
        • Contact:
    • California
      • Garden Grove, California, United States, 92844
        • Recruiting
        • National Institute Of Clinical Research
        • Principal Investigator:
          • Michael Dao, MD
        • Contact:
      • Montclair, California, United States, 91763
        • Recruiting
        • Catalina Research Institute
        • Principal Investigator:
          • Rizwana Mohseni, MD
        • Contact:
      • Orange, California, United States, 92868
        • Recruiting
        • Knowledge Research Center
        • Principal Investigator:
          • Alaa Abousaif, MD
        • Contact:
    • Florida
      • Orlando, Florida, United States, 32803
    • Illinois
      • Chicago, Illinois, United States, 60618
    • Louisiana
      • Bastrop, Louisiana, United States, 71220
      • West Monroe, Louisiana, United States, 71291
    • Michigan
      • Clinton Township, Michigan, United States, 48038
        • Recruiting
        • Clinical Research Institute of Michigan
        • Principal Investigator:
          • Ronald Fogel, MD
        • Contact:
    • Minnesota
      • Saint Paul, Minnesota, United States, 55114
        • Recruiting
        • Nucleus Network Minneapolis
        • Contact:
        • Principal Investigator:
          • Trish Shamp, PhD
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Recruiting
        • Kansas City Research Institute
        • Contact:
      • St Louis, Missouri, United States, 63123
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Jubilee Clinical Research, LLC.
        • Contact:
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
    • Ohio
      • Westlake, Ohio, United States, 44145
        • Recruiting
        • Clinical Research Institute of Ohio, LLC (CRIOH)
        • Contact:
    • Oklahoma
      • Yukon, Oklahoma, United States, 73099
        • Recruiting
        • Tekton Research - Yukon
        • Contact:
    • Tennessee
      • Clarksville, Tennessee, United States, 37040
        • Recruiting
        • Innovative Clinical Research, LLC
        • Contact:
    • Texas
      • Austin, Texas, United States, 78757
      • Austin, Texas, United States, 78745
      • Bellaire, Texas, United States, 77401
      • Corpus Christi, Texas, United States, 78404
        • Recruiting
        • Pinnacle Clinical Research - Corpus Christi
        • Contact:
      • Georgetown, Texas, United States, 78626
        • Recruiting
        • Pinnacle Clinical Research - Georgetown
        • Contact:
      • Houston, Texas, United States, 77079
      • Houston, Texas, United States, 77030
      • Pasadena, Texas, United States, 77505
      • San Antonio, Texas, United States, 78229
      • San Antonio, Texas, United States, 78209
        • Recruiting
        • Quality Research
        • Principal Investigator:
          • Robert Morin, MD
        • Contact:
      • Sugar Land, Texas, United States, 77478

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HU6 450 mg
450 mg Once Daily (QD)
Drug: HU6
HU6 is being evaluated for efficacy in MASH
Experimental: HU6 300 mg
300 mg Twice Daily (BID)
Drug: HU6
HU6 is being evaluated for efficacy in MASH
Placebo Comparator: Placebo Once Daily
Placebo Once Daily (QD)
Other: Placebo
Placebo comparator
Placebo Comparator: Placebo Twice Daily
Placebo Twice Daily (BID)
Other: Placebo
Placebo comparator

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rivus Pharmaceuticals, Inc.

Investigators

  • Study Director: Stefanie Mason, MD, Rivus Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • RIV-HU6-2204

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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