RecruitingPhase 2

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

United States180 participantsStarted 2026-02-13

Plain-language 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.

Who can participate

Age range

30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 hosp…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number and Percentage of Adverse Events (AEs)

Timeframe: 26 weeks

Percent change from baseline to Week 26 In Liver Fat Assessed by MRI-PDFF

Timeframe: 26 weeks

Percentage of participants with Liver Fat reduction by ≥30% Assessed by MRI-PDFF

Timeframe: 26 weeks

Area Under the Plasma Concentration-Time Curve (AUC)

Timeframe: 26 weeks

Trough Plasma Concentration (Ctrough)

Timeframe: 26 weeks

Maximum Observed Plasma Concentration (Cmax)

Timeframe: 26 weeks

Time to Maximum Plasma Concentration (Tmax)

Timeframe: 26 weeks

Plasma Clearance of drug after extravascular administration (CL/F)

Trial details

NCT IDNCT07491458

SponsorRivus Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-02

Contact for this trial

Clinical Operations Lead

6173887757 jsoto@rivuspharma.com

View on ClinicalTrials.gov More MASH - Metabolic Dysfunction-Associated Steatohepatitis trials

Plain-language summary

Who can participate

Age range

30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number and Percentage of Adverse Events (AEs)

Timeframe: 26 weeks

Percent change from baseline to Week 26 In Liver Fat Assessed by MRI-PDFF

Timeframe: 26 weeks

Percentage of participants with Liver Fat reduction by ≥30% Assessed by MRI-PDFF

Timeframe: 26 weeks

Area Under the Plasma Concentration-Time Curve (AUC)

Timeframe: 26 weeks

Trough Plasma Concentration (Ctrough)

Timeframe: 26 weeks

Maximum Observed Plasma Concentration (Cmax)

Timeframe: 26 weeks

Time to Maximum Plasma Concentration (Tmax)

Timeframe: 26 weeks

Plasma Clearance of drug after extravascular administration (CL/F)