MASH - Metabolic Dysfunction-Associated SteatohepatitisPhase 2AMPLIFYNCT07491458
A Trial to Investigate Safety, Exposure, and Efficacy of HU6 Compared With Placebo in Adult Participants With Metabolic Dysfunction-associated Steatohepatitis (MASH)
A Phase 2 study testing HU6 in people with MASH - Metabolic Dysfunction-Associated Steatohepatitis, run by Rivus Pharmaceuticals, Inc. at 31 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- MASH - Metabolic Dysfunction-Associated Steatohepatitis
- What is being tested?
- HU6
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 31 sitesUnited States
- Study dates
- 13 Feb 2026to Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
31 sites in 1 country. Contact the study team or a site near you to ask about taking part.
31 sites in 1 country
United States31 sites, 31 recruiting
- Recruiting
IMA Clinical Research (Austin)
Austin, Texas, 78745
Kate Banks, 512-649-0082, kate.banks@imaresearch.com
- Recruiting
Pinnacle Clinical Research - Austin
Austin, Texas, 78757
Maria Macias, 512-384-1560, mmacias@pinnacleresearch.com
- Recruiting
Delta Research Partners of Bastrop, LLC
Bastrop, Louisiana, 71220
Casey Petrus, 904-854-1354, casey.petrus@roviaclinical.com
- Recruiting
Bellaire Clinical Research, LLC
Bellaire, Texas, 77401
Layla Haider, 844-399-0449, lhaidar@pinnacleresearch.com
- Recruiting
Arizona Liver Health - Chandler
Chandler, Arizona, 85224
Enrique Topete, 480-470-4000, etopete@azclinicaltrials.com
- Recruiting
Charter Research LLC - Chicago
Chicago, Illinois, 60618
Teresa Kalowsky, 773-997-1000, Teresa.Kalowsky@charterresearch.com
- Recruiting
Innovative Clinical Research, LLC
Clarksville, Tennessee, 37040
Mary Kosinski, 847-469-6971, mkosinski@ICRresearch.com
- Recruiting
Clinical Research Institute of Michigan
Clinton Township, Michigan, 48038
Karie Simmons, 586-598-3329, ksimons@researchmi.com
Ronald Fogel, MD
- Recruiting
Pinnacle Clinical Research - Corpus Christi
Corpus Christi, Texas, 78404
Ashley Giron, 361-400-5352, agiron@pinnacleresearch.com
- Recruiting
Coastal Research Institute
Fayetteville, North Carolina, 28304
Jessica Maples, 910-500-3146, jmaples@coastalresearchnc.com
- Recruiting
National Institute of Clinical Research
Garden Grove, California, 92844
Ryan Dudley, 323-725-0657, rdudley@nicresearch.com
Michael Dao, MD
- Recruiting
Pinnacle Clinical Research - Georgetown
Georgetown, Texas, 78626
Nirupama Jerome, 737-444-8408, njerome@pinnacleresearch.com
- Recruiting
HRI - Medical Center, LLC
Houston, Texas, 77030
Callie Pettigrew, 713-794-0700, cpettigrew@houstonresearchinstitute.com
- Recruiting
Houston Research Institute
Houston, Texas, 77079
Evelyn Gonzalez, 281-809-3234, egonzalez1@pinnacleresearch.com
- Recruiting
Kansas City Research Institute
Kansas City, Missouri, 64131
Taleah Brown, 816-759-5274, tbrown@kcri.health
- Recruiting
Jubilee Clinical Research, LLC.
Las Vegas, Nevada, 89106
Julie Gass, 702-631-5000, jgass@jcr-lv.com
- Recruiting
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205
Karen Willis, 501-224-1348, kmwillis@bhccr.com
- Recruiting
Catalina Research Institute
Montclair, California, 91763
Michael Gallardo, 909-590-8409, michael.gallardo@elixiahealth.com
Rizwana Mohseni, MD
- Recruiting
Knowledge Research Center
Orange, California, 92868
Aleesha Browning, 657-247-0087, abrowning@krcorange.com
Alaa Abousaif, MD
- Recruiting
Charter Research LLC - Orlando
Orlando, Florida, 32803
Valeria Robles, 407-337-3000, valeria.robles@charterresearch.com
- Recruiting
HRI - Pasadena, LLC
Pasadena, Texas, 77505
Layla Haidar, 281-809-3234, lhaidar@pinnacleresearch.com
- Recruiting
Arizona Liver Health - Peoria
Peoria, Arizona, 85381
Ann Moore, 480-470-4000, amoore@azliver.com
- Recruiting
Nucleus Network Minneapolis
Saint Paul, Minnesota, 55114
Kate Tilley, 651-641-2900, k.tilley@nucleusnetwork.com
Trish Shamp, PhD
- Recruiting
Quality Research
San Antonio, Texas, 78209
Chelsie Lopez, 210-864-8844, c.lopez@qualityresearch.com
Robert Morin, MD
- Recruiting
Pinnacle Clinical Research - San Antonio
San Antonio, Texas, 78229
Mary Lou Hernandez, 210-982-0320, mhernandez@pinnacleresearch.com
- Recruiting
KAD Clinical Research
St Louis, Missouri, 63123
Kristina Wriston, 314-254-3168, kwriston@kadclinicalresearch.com
- Recruiting
HRI - Sugarland, LLC
Sugar Land, Texas, 77478
Tania Deras, 281-809-3234, tderas@houstonresearchinstitute.com
- Recruiting
Arizona Liver Health - Tucson
Tucson, Arizona, 85712
Vivian Martinez, 520-485-4000, vmartinez@azliver.com
- Recruiting
Delta Research Partners of West Monroe, LLC
West Monroe, Louisiana, 71291
Jennifer Davidson, 904-854-1354, jennifer.davidson@roviaclinical.com
- Recruiting
Clinical Research Institute of Ohio, LLC (CRIOH)
Westlake, Ohio, 44145
Mousab Tabbaac, 440-363-4000, MTabbaa@ohioresearch.com
- Recruiting
Tekton Research - Yukon
Yukon, Oklahoma, 73099
Laura Fumero, 855-380-2822, lfumero@evotrials.com
About this study
Official title: 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.
Read the 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.
- Being tested
- HU6, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HU6Drug
HU6 is being evaluated for efficacy in MASH
PlaceboOther
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| HU6 450 mg | Experimental | 450 mg Once Daily (QD) Receives: Drug: HU6 |
| HU6 300 mg | Experimental | 300 mg Twice Daily (BID) Receives: Drug: HU6 |
| Placebo Once Daily | Placebo comparator | Placebo Once Daily (QD) Receives: Other: Placebo |
| Placebo Twice Daily | Placebo comparator | Placebo Twice Daily (BID) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Percentage of Adverse Events (AEs)
Measured: 26 weeks
Percent change from baseline to Week 26 In Liver Fat Assessed by MRI-PDFF
Measured: 26 weeks
Percentage of participants with Liver Fat reduction by ≥30% Assessed by MRI-PDFF
Measured: 26 weeks
Area Under the Plasma Concentration-Time Curve (AUC)
Measured: 26 weeks
Trough Plasma Concentration (Ctrough)
Measured: 26 weeks
Maximum Observed Plasma Concentration (Cmax)
Measured: 26 weeks
Time to Maximum Plasma Concentration (Tmax)
Measured: 26 weeks
Plasma Clearance of drug after extravascular administration (CL/F)
Measured: 26 weeks
Volume of distribution after extravascular administration (V/F)
Measured: 26 weeks
Drug elimination half-life (t½)
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start13 Feb 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASH - Metabolic Dysfunction-Associated SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rivus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefanie Mason, MD, Study director, Rivus Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491458
- Sponsor's protocol ID
- RIV-HU6-2204
- Acronym
- AMPLIFY
- Status last verified
- May 2026
- First submitted
- 2 Mar 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07491458
- Acronym / sponsor ID
- AMPLIFY / RIV-HU6-2204
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Rivus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HU6 450 mg | Experimental | Drug: HU6450 mg Once Daily (QD) |
| HU6 300 mg | Experimental | Drug: HU6300 mg Twice Daily (BID) |
| Placebo Once Daily | Placebo comparator | Other: PlaceboPlacebo Once Daily (QD) |
| Placebo Twice Daily | Placebo comparator | Other: PlaceboPlacebo Twice Daily (BID) |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HU6HU6 is being evaluated for efficacy in MASH | Drug | HU6 300 mg, HU6 450 mg |
| PlaceboPlacebo comparator | Other | Placebo Once Daily, Placebo Twice Daily |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
Related trials for MASH - Metabolic Dysfunction-Associated Steatohepatitis
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LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
Metabolic Dysfunction Associated Steatohepatitis (MASH), Liver Fibrosis
Recruiting
Exercise for an Aging Liver (EXALIVER)
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, MASH - Metabolic Dysfunction-Associated Steatohepatitis
RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
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RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefanie Mason, MD study director
Rivus Pharmaceuticals, Inc.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HU6 in people with MASH - Metabolic Dysfunction-Associated Steatohepatitis, run by Rivus Pharmaceuticals, Inc. at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Operations Lead (6173887757, jsoto@rivuspharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and Percentage of Adverse Events (AEs) (time frame: 26 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.