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
🩺 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: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (64 items).
Location: ProSciento CRU — Chula Vista, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: Subjects will be excluded from the study if any of the following criteria are met:
- The subject has a history of cirrhosis and/or hepatic decompensation, including ascites, hepatic encephalopathy, or variceal bleeding.
- The subject has a history of acute pancreatitis within 1 year of Screening or chronic pancreatitis of any cause.
- History of any bariatric surgery intervention, including but not limited to lap banding, intragastric balloon, duodenal-jejunal sleeve, or bariatric surgery or plans for bariatric surgery prior to conclusion of study participation.
- Have obesity induced by other endocrinologic disorders (e.g., Cushing Syndrome, polycystic ovarian syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., Melanocortin 4 Receptor deficiency or Prader-Willi Syndrome).
- Any surgical or medical condition or history that, in the opinion of the investigator in consultation with the medical monitor, may potentially alter the absorption, metabolism, or excretion of study treatment.
- History of or treatment for clinically significant gastroparesis, inflammatory bowel disease, or any surgery of the upper gastrointestinal tract with the exception of cholecystectomy, or minor gastric procedures that are approved by the medical monitor.
- History (including any family history) of malignant hyperthermia.
- History of chronic serious recurrent skin rashes of unknown cause.
- History of malignancy within 5 years (except cutaneous basal or squamous cell carcinoma, carcinoma-in-situ, or low-grade prostate cancer).
- History of the following cardiovascular conditions within 3 months prior to randomization: acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, hospitalization due to congestive heart failure (CHF), or acute CHF.
- NYHA Functional Class II, III, or IV heart failure.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (20 Sites)
- ProSciento CRU — Chula Vista, California
- Velocity Clinical Research — Los Angeles, California
- Catalina Research Institute — Montclair, California
- Northern California Research Center — Sacramento, California
- Metro Clinical Trials — San Bernardino, California
- Synergy Healthcare — Bradenton, Florida
- ABMED Clinical Research Corp. — Cape Coral, Florida
- Southwest General Healthcare Center — Fort Myers, Florida
- Miami Clinical Research — Miami, Florida
- Advanced Clinical Research — Miami, Florida
- Century Research, LLC — Miami, Florida
- Entrust Clinical Research — Miami, Florida
- Panax Clinical Research — Miami Lakes, Florida
- Tandem Clinical Research — Marrero, Louisiana
- CenExel HRI — Berlin, New Jersey
- Lillestol Research — Fargo, North Dakota
- IMA Clinical Research-Austin — Austin, Texas
- Mt Olympus Medical Research — Houston, Texas
- Houston Research Institute — Houston, Texas
- Texas Liver Institute — San Antonio, Texas
💰 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 § 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.