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NCT04932512 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of ION224
A Phase 2 study of Steatohepatitis, Nonalcoholic, sponsored by Ionis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
- 20
- Study locations
NCT04932512: Completed Phase 2 study of Steatohepatitis, Nonalcoholic, sponsored by Ionis Pharmaceuticals.
NCT04932512 is a Phase 2 study of Steatohepatitis, Nonalcoholic that has completed, run by Ionis Pharmaceuticals. The registered enrollment target is 160 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04932512, a Phase 2 study of Steatohepatitis, Nonalcoholic, has completed, sponsored by Ionis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the effect of multiple ION224 doses when administered by subcutaneous (SC) injection for 49 weeks (end of the treatment \[EOT\]) on non-alcoholic steatohepatitis (NASH) histologic improvement and to assess the effect on liver steatosis by magnetic resonance imaging-determined proton density fat fraction (MRI-PDFF), additional changes in NASH histologic features, liver biochemistry tests, and plasma lipid profile.
Primary Outcome
The NAS is a histology grading score composed on the assessment of steatosis (scale 0-3), hepatocellular ballooning (scale 0-2), and lobular inflammation (scale 0-3), with higher scores indicating more severe hepatitis. Worsening of fibrosis is defined as an increase in fibrosis of at least one stage on the Kleiner fibrosis classification: fibrosis stages range from 0-4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis).
Conditions Studied
Interventions
- OTHER Placebo
- DRUG ION224
Study Locations (20)
Florida
- Excel Medical Clinical Trials, LLC - Boca Raton
- Tampa Bay Medical Research, Inc. - Clearwater
- Southwest General Medical Center - Fort Myers
- Evolution Clinical Trials, INC - Hialeah Gardens
- ClinCloud, LLC. - Maitland
- Advanced Pharma CR, LLC - Miami
- La Salud Research - Miami
- Entrust Clinical Research - Miami
- Floridian Clinical Research, LLC. - Miami Lakes
California
- GW Research, Inc. - Chula Vista
- National Research Institute - Gardena - Gardena
- National Research Institute - Huntington Park
- National Research Institute - Los Angeles
- National Research Institute Panorama City - Panorama City
- National Research Institute - Santa Ana - Santa Ana
Arizona
- Arizona Liver Health-Chandler - Chandler
- Arizona Liver Health - Glendale
- Arizona Liver Health - Tucson
Arkansas
- Arkansas Gastroenterology - North Little Rock - North Little Rock
Colorado
- South Denver Gastroenterology, PC - Englewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2021-06-17 |
| Est. Completion | 2024-02-28 |
| Phase | Phase 2 |
What the finished NCT04932512 record still lists
NCT04932512 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher).
The record links to 1 condition, with Steatohepatitis, Nonalcoholic appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04932512 names 20 study sites across 5 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT04932512 about?
NCT04932512 is a clinical study titled "A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of ION224". The purpose of this study is to assess the effect of multiple ION224 doses when administered by subcutaneous (SC) injection for 49 weeks (end of the treatment \[EOT\]) on non-alcoholic steatohepatitis (NASH) histologic improvement and to assess the effect on liver steatosis by magnetic resonance ima...
What is the current status of trial NCT04932512?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2021-06-17. Estimated completion is 2024-02-28.
What conditions does trial NCT04932512 study?
This clinical trial studies the following conditions: Steatohepatitis, Nonalcoholic.
What interventions are being tested in trial NCT04932512?
The interventions under investigation include: Placebo (OTHER), ION224 (DRUG).
Who is sponsoring clinical trial NCT04932512?
This trial is sponsored by Ionis Pharmaceuticals, which has 76 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04932512 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04932512's enrollment target sits among peer trials
160 422nd of 2000 higher than 1,559 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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