A Trial to Investigate Safety, Exposure, and Efficacy of HU6 Compared With Placebo in Adult Participants With Metabolic Dysfunction-associated Steatohepatitis (MASH)
Part of paid clinical trials in Chandler, Arizona.
- Sponsor
- Rivus Pharmaceuticals, Inc.
- Study ID
- NCT07491458
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- MASH - Metabolic Dysfunction-Associated Steatohepatitis
Eligibility Criteria
- Sex
- ALL
- Age
- 30 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- HU6 — DRUGHU6 is being evaluated for efficacy in MASH
- Placebo — OTHERPlacebo comparator
Study Details
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.
Key Dates
- Start date
- Feb 13, 2026
- Status verified
- May 2026
- Primary completion
- Feb 28, 2027
- Completion
- Feb 29, 2028
Study Design
- Enrollment
- 180 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: HU6 450 mg450 mg Once Daily (QD)
- Experimental: HU6 300 mg300 mg Twice Daily (BID)
- Placebo Comparator: Placebo Once DailyPlacebo Once Daily (QD)
- Placebo Comparator: Placebo Twice DailyPlacebo Twice Daily (BID)
Primary Outcome Measure
Number and Percentage of Adverse Events (AEs) [ Time Frame: 26 weeks ]
Central Contacts
- Clinical Operations Lead6173887757
- VP, Clinical Operations8435683621
Locations (31)
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