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NCT05979779 · ClinicalTrials.gov registry record · Phase 2
Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis
A Phase 2 study of Non-alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, sponsored by Rivus Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 219
- Enrollment target
- 20
- Study locations
NCT05979779: Active Phase 2 study of Non-alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, sponsored by Rivus Pharmaceuticals.
NCT05979779 is a Phase 2 study of Non-alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis that is active but no longer recruiting, run by Rivus Pharmaceuticals. The registered enrollment target is 219 participants, above the 173-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (27% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05979779, a Phase 2 study of Non-alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, is active but no longer recruiting, sponsored by Rivus Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 219 participants
- Enrollment target
- 20
- Study locations
Study 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).
Conditions Studied
Interventions
- OTHER Placebo
- DRUG HU6
Study Locations (20)
Florida
- Synergy Healthcare - Bradenton
- ABMED Clinical Research Corp. - Cape Coral
- Southwest General Healthcare Center - Fort Myers
- Miami Clinical Research - Miami
- Advanced Clinical Research - Miami
- Century Research, LLC - Miami
- Entrust Clinical Research - Miami
- Panax Clinical Research - Miami Lakes
California
- ProSciento CRU - Chula Vista
- Velocity Clinical Research - Los Angeles
- Catalina Research Institute - Montclair
- Northern California Research Center - Sacramento
- Metro Clinical Trials - San Bernardino
Texas
- IMA Clinical Research-Austin - Austin
- Mt Olympus Medical Research - Houston
- Houston Research Institute - Houston
- Texas Liver Institute - San Antonio
Louisiana
- Tandem Clinical Research - Marrero
New Jersey
- CenExel HRI - Berlin
North Dakota
- Lillestol Research - Fargo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 219 participants |
| Start Date | 2023-09-05 |
| Est. Completion | 2025-06 |
| Phase | Phase 2 |
What the registry record for NCT05979779 still lists
NCT05979779 is an interventional study that assigns participants to a tested intervention. The registered 219 participants enrollment target is mid-sized for trials with a published cap, above the 173-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (27% higher).
The record links to 3 conditions, with Non-alcoholic Fatty Liver Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05979779 names 20 study sites across 6 states, led by Florida, California, Texas.
Frequently Asked Questions
What is clinical trial NCT05979779 about?
NCT05979779 is a clinical study titled "Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis". 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 pharmacokinetic...
What is the current status of trial NCT05979779?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 219 participants. The study started on 2023-09-05. Estimated completion is 2025-06.
What conditions does trial NCT05979779 study?
This clinical trial studies the following conditions: Non-alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis, Fatty Liver.
What interventions are being tested in trial NCT05979779?
The interventions under investigation include: Placebo (OTHER), HU6 (DRUG).
Who is sponsoring clinical trial NCT05979779?
This trial is sponsored by Rivus Pharmaceuticals, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05979779 being conducted?
This trial has 20 study locations across California, Florida, Louisiana, New Jersey, North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05979779's enrollment target sits among peer trials
219 11th of 57 higher than 47 of 57 other Non-alcoholic Fatty Liver Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-alcoholic Fatty Liver Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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