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.
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
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).
Parallel
HU6
DrugHU6 is being evaluated for efficacy in MASH
Placebo
Other interventionPlacebo comparator
Number and Percentage of Adverse Events (AEs)
Percent change from baseline to Week 26 In Liver Fat Assessed by MRI-PDFF
Percentage of participants with Liver Fat reduction by ≥30% Assessed by MRI-PDFF
Area Under the Plasma Concentration-Time Curve (AUC)
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