NCT04932512Phase 2Completed

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

Study sponsor: Ionis Pharmaceuticals, Inc. · IONS

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2024-01-10Actual

Enrollment · participants160Actual

Source updated2024-11-27Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Steatohepatitis, Nonalcoholic

Treatments or interventions studied

ION224Drug

Primary outcomes · main study measures

Read the study measures

measure: Percentage of Participants With at Least 2-point Reduction in Non-alcoholic Fatty Liver Disease Activity Score (NAS) With at least 1-point Improvement in Hepatocellular Ballooning or Lobular Inflammation, and Without Worsening in Fibrosis Stage at EOT; description: 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).; timeFrame: Up to Week 49

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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