ION224 for Non-alcoholic Fatty Liver Disease

Phase 2

Waitlist Available

Research Sponsored by Ionis Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ALT and AST ≤ 200 units per liter (U/L) and confirmed to be stable

Total Bilirubin ≤ 1.3 milligrams per deciliter (mg/dL) and confirmed to be stable

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 49

Summary

This trial tests if ION224 injections can help patients with NASH by reducing liver fat and improving liver health. The study will monitor changes in liver condition using imaging and blood tests over several months.

Eligible Conditions

Non-alcoholic Fatty Liver Disease (NAFLD)

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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Your liver enzyme levels (ALT and AST) should be below 200 units per liter and remain stable.

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Your total bilirubin level must be below 1.3 mg/dL and not changing over time.

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You have not had a liver biopsy in the last 6 months.

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Do you have a metal implant that would stop you from having a certain type of medical scan called an MRI?

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Are you currently taking medication to lower your cholesterol levels?

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Are you planning to have weight loss surgery in the next year?

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You had cancer within the last 3 years and received treatment for it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 49

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 49

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 49 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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