drugset / Trial / NCT05979779

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

NCT05979779 ↗

Phase 2 Active not recruiting 219 enrolled Rivus Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2023-09-05
Primary completion
2025-01-21
Completion
2025-06

Drugs

EvaluationDrugModalityDoseRoute
Subject HU6 Unknown 150 mg —
Subject HU6 Unknown 300 mg —
Subject HU6 Unknown 450 mg —