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COMPLETED Phase 2

A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of ION224

NCT04932512 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 160 participants
Start Date 2021-06-17
Est. Completion 2024-02-28
Phase Phase 2

Sponsor

Ionis Pharmaceuticals

55 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 55 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04932512 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04932512?

The interventions under investigation include: Placebo (OTHER), ION224 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04932512?

This trial is sponsored by Ionis Pharmaceuticals, which has 55 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial