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.
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.
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,…
Eligibility
- Age range
- 30+ years
- Sex
- All
- Healthy volunteers
- No
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 conditi…
Interventions
- DrugHU6
HU6 is being evaluated for efficacy in MASH
- OtherPlacebo
Placebo comparator
Locations (33)
- Arizona Liver Health - ChandlerChandler, Arizona
- Arizona Liver Health - PeoriaPeoria, Arizona
- Arizona Liver Health - TucsonTucson, Arizona
- Baptist Health Center for Clinical ResearchLittle Rock, Arkansas
- Ark Clinical Research - Fountain ValleyFountain Valley, California
- National Institute of Clinical ResearchGarden Grove, California