A Phase 2a, Double-blind, 4-arm Trial Evaluating Safety, Exposure, and Efficacy of HU6 Compared With Placebo in Adults 30 Years or Older With Metabolic Dysfunction-associated Steatohepatitis (MASH)

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effects of HU6 in adults aged 30 years or older diagnosed with metabolic dysfunction-associated steatohepatitis (MASH). The study aims to assess how HU6 affects liver fat content and other symptoms related to MASH, along with understanding its pharmacokinetics and safety profile. This is a phase 2a, randomized, double-blind, placebo-controlled trial sponsored by Rivus Pharmaceuticals, Inc. Participants are randomly assigned to one of four groups receiving either HU6 at 450 mg once daily, HU6 at 300 mg twice daily, placebo once daily, or placebo twice daily. The trial has two parts: a blinded intervention period followed by an optional open-label extension for those who complete the first phase. The blinded period includes screening, treatment, an end of treatment or early termination visit, a safety follow-up visit, and two long-term follow-up visits. During the study, participants will undergo assessments including MRI scans to measure liver fat, laboratory tests, and monitoring of drug levels in the blood. Researchers will track adverse events and measure the drug's pharmacokinetics over 26 weeks. The total study duration includes multiple visits for safety and long-term observation to better understand the effects and safety of HU6 in treating MASH.

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