Clinical Trial

Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis

Active, Not Recruiting Phase 2
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Summary
This is a phase 2 randomized, double-blind, placebo-controlled parallel group study of 3 dose levels of HU6 in subjects with nonalcoholic steatohepatitis (NASH). Six months (26 weeks) of dosing is planned, and subjects will be followed for safety, efficacy, pharmacodynamics (PD), and pharmacokinetics (PK) during this time. The end-of-study visit will take place approximately 4 weeks after the last dose of the study drug (Week 30).
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-07-31; most recent amendment 2025-04-15.
Status change: Recruiting → Active, Not Recruiting 2024-07-19
Status change: Not Yet Recruiting → Recruiting 2023-10-14
Trial Details
NCT Number NCT05979779
Lead Sponsor Rivus Pharmaceuticals, Inc.
Conditions Non-Alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis, Fatty Liver
Enrollment 219 participants
Start Date 2023-09-05
Primary Completion 2025-01-21 (estimated)
Study Completion 2025-06 (estimated)
Updated on ClinicalTrials.gov 2025-04-18