๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-04-15

Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis (NCT05979779)

A 6-Month, Randomized, Double-Blind, Placebo-controlled, Phase 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Rivus Pharmaceuticals, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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).

Who can join: Review the eligibility criteria below.

Location: ProSciento CRU โ€” Chula Vista, California

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (20 Sites)

  • ProSciento CRU โ€” Chula Vista, California
  • Velocity Clinical Research โ€” Los Angeles, California
  • Catalina Research Institute โ€” Montclair, California
  • Northern California Research Center โ€” Sacramento, California
  • Metro Clinical Trials โ€” San Bernardino, California
  • Synergy Healthcare โ€” Bradenton, Florida
  • ABMED Clinical Research Corp. โ€” Cape Coral, Florida
  • Southwest General Healthcare Center โ€” Fort Myers, Florida
  • Miami Clinical Research โ€” Miami, Florida
  • Advanced Clinical Research โ€” Miami, Florida
  • Century Research, LLC โ€” Miami, Florida
  • Entrust Clinical Research โ€” Miami, Florida
  • Panax Clinical Research โ€” Miami Lakes, Florida
  • Tandem Clinical Research โ€” Marrero, Louisiana
  • CenExel HRI โ€” Berlin, New Jersey
  • Lillestol Research โ€” Fargo, North Dakota
  • IMA Clinical Research-Austin โ€” Austin, Texas
  • Mt Olympus Medical Research โ€” Houston, Texas
  • Houston Research Institute โ€” Houston, Texas
  • Texas Liver Institute โ€” San Antonio, Texas

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—