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Clinical Trial 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).


Clinical Trial Description

This is a phase 2 randomized, double-blind, placebo-controlled parallel group study of 3 dose levels of HU6 (150 mg, 300 mg, and 450 mg) and placebo in approximately 204 subjects with NASH. Subjects will be screened over a 49-day period to determine their eligibility based on specific history, physical, laboratory, and imaging evaluations, which will require more than one visit during the screening period. On Day 1, subjects will be randomized 2:1:2:2 into 1 of 4 treatment groups (placebo, 150 mg HU6, 300 mg HU6, or 450 mg HU6). Six months (26 weeks) of dosing is planned, and subjects will be followed for safety, efficacy, PD, and 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05979779
Study type Interventional
Source Rivus Pharmaceuticals, Inc.
Contact Jasminder Soto
Phone 6173887757
Email jsoto@rivuspharma.com
Status Recruiting
Phase Phase 2
Start date September 5, 2023
Completion date April 2025

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