NCT07491458

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

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Rivus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Detailed 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, and two long-term follow up visits.

Conditions

• MASH - Metabolic Dysfunction-Associated Steatohepatitis

Interventions

Type	Name	Description
DRUG	HU6	HU6 is being evaluated for efficacy in MASH
OTHER	Placebo	Placebo comparator

Timeline

• Start date: 2026-02-13
• Primary completion: 2027-02-01
• Completion: 2028-02-01
• First posted: 2026-03-24
• Last updated: 2026-03-24

Locations

33 sites across 1 country: United States

Regulatory

• FDA-regulated drug study