Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study of Steatohepatitis, Nonalcoholic that has completed, run by Ionis Pharmaceuticals. The registered enrollment target is 160 participants. The trial reports 20 study locations across 5 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04932512
The ClinicalTrials.gov registry entry for NCT04932512 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ionis Pharmaceuticals, which has 76 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.