RecruitingMASH - Metabolic Dysfunction-Associated Steatohepatitis

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

Eligible age

30+ yrs

Accepts

All genders

Locations

15 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

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.

Sponsor: Rivus Pharmaceuticals, Inc.

You may qualify if…

✓ 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

You may not qualify if…

✕ 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.