Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ION224 · 1 trial · 1 indication
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).
| Arm | Type | Description |
|---|---|---|
| ION224 | EXPERIMENTAL | Multiple doses of ION224 will be administered by SC injection once every 4 weeks for up to 49 weeks. |
| Placebo | PLACEBO_COMPARATOR | Multiple doses of matching placebo will be administered by SC injection once every 4 weeks for up to 49 weeks. |
| Name | Type | Description |
|---|---|---|
| ION224 | DRUG | ION224 will be administered by SC injection. |
| Placebo | OTHER | ION224-matching placebo solution will be administered by SC injection. |
Inclusion Criteria: * Males or females greater than or equal to (≥) 18 and less than or equal to (≤) 75 years old at the time of informed consent * Body mass index ≥ 25 kg/m\^2 and ≥ 22 kg/m\^2 for participants of Asian race, as assessed during screening * Liver fat ≥ 10% as assessed by MRI-PDFF be...
ION224 is an investigational small molecule being developed for the treatment of nonalcoholic steatohepatitis (NASH), a form of fatty liver disease. It is currently in Phase 2 clinical development and is not yet approved by the FDA.
ION224 is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IONS. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
ION224 is in Phase 2 clinical development. A Phase 2 study has been completed, but the drug remains investigational and has not received regulatory approval. Further clinical trials may be needed to establish its safety and efficacy.
ION224 has been studied in a completed Phase 2 clinical trial identified as NCT04932512. This randomized, double-blind, placebo-controlled study enrolled 160 participants with nonalcoholic steatohepatitis at sites in the United States and Puerto Rico.
ION224 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. The completed Phase 2 trial assessed its safety, efficacy, and pharmacokinetics, but the drug has not yet been submitted for regulatory approval.