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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 belowSelect...
Your liver enzyme levels (ALT and AST) should be below 200 units per liter and remain stable.
Select...
Your total bilirubin level must be below 1.3 mg/dL and not changing over time.
Select...
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
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
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ION224Experimental Treatment1 Intervention
Multiple doses of ION224 will be administered by SC injection once every 4 weeks for up to 49 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Multiple doses of matching placebo will be administered by SC injection once every 4 weeks for up to 49 weeks.
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Who is running the clinical trial?
Ionis Pharmaceuticals, Inc.Lead Sponsor
150 Previous Clinical Trials
27,502 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
105 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your liver enzyme levels (ALT and AST) should be below 200 units per liter and remain stable.You have not had a liver biopsy in the last 6 months.Your total bilirubin level must be below 1.3 mg/dL and not changing over time.Do you have a metal implant that would stop you from having a certain type of medical scan called an MRI?Are you currently taking medication to lower your cholesterol levels?Are you planning to have weight loss surgery in the next year?You had cancer within the last 3 years and received treatment for it.
Research Study Groups:
This trial has the following groups:- Group 1: ION224
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT04932512 — Phase 2