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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 baseline up to week 15, week 29 and week 49
Awards & highlights

Study Summary

This trial will study the effects of a new medication on non-alcoholic steatohepatitis, a liver condition.

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 weeks
Treatment ~ Varies
Follow Up ~baseline up to week 15, week 29 and week 49
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to week 15, week 29 and week 49 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
Absolute Change From Baseline in Liver-related Laboratory Test - ALT
Absolute Change From Baseline in Liver-related Laboratory Test - AST
Absolute Change From Baseline in Liver-related Laboratory Test - Gamma-glutamyl Transferase
+14 more

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.

Find a Location

Who is running the clinical trial?

Ionis Pharmaceuticals, Inc.Lead Sponsor
146 Previous Clinical Trials
15,122 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
105 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

ION224 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04932512 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: ION224, Placebo
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: ION224 Highlights & Side Effects. Trial Name: NCT04932512 — Phase 2
ION224 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04932512 — Phase 2
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT04932512 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would this research benefit from a more diverse pool of test subjects?

"The age limit for this particular study is set at 18 to 75 years old. There are 24 similar studies that cater to patients below the age of majority and 203 research projects focused on senior citizens."

Answered by AI

Could I possibly take part in this clinical trial?

"This trial is searching for 150 individuals that have fatty liver and meet the following age requirements: 18-75. Additionally, these patients must have the following conditions: 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, Have you had a liver biopsy in the past 6 months?, Do you have a metal implant that would prevent you from having an MRI?, Are you taking any cholesterol-lowering drugs?, Do you have a planned weight loss surgery during"

Answered by AI

Is this experiment still looking for volunteers?

"From what is listed on clinicaltrials.gov, this trial is still recruiting patients. The first posting was on June 17th, 2021 with the most recent update October 13th, 2022."

Answered by AI

Are there different research facilities testing this hypothesis across the nation?

"Tandem Clinical Research GI, LLC. in New york, New York, WR-ClinSearch, LLC in Chattanooga, Tennessee, and Evolution Clinical Trials, INC in Hialeah Gardens, Texas are a few of the 57 other locations where this clinical trial is running."

Answered by AI

Could you please outline the risks associated with ION224?

"ION224 falls in Phase 2 of medical trials. This means that while there is some data supporting its safety, there are no studies yet backing up its efficacy. Therefore, our team has given it a score of 2."

Answered by AI

How many people have registered for this clinical trial thus far?

"One hundred and fifty individuals that match the required profile are needed for this clinical trial. Tandem Clinical Research GI, LLC. in New york, New York and WR-ClinSearch, LLC in Chattanooga, Tennessee are two of the many sites where patients can participate."

Answered by AI

Who else is applying?

What state do they live in?
California
Texas
Florida
Other
How old are they?
65+
18 - 65
What site did they apply to?
National Research Institute Panorama City
National Research Institute - Gardena
Advanced Research Institute
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0

Why did patients apply to this trial?

Fatty liver with fibrosis. I really don't know much about it. Looking for help to reverse my diagnosis.
PatientReceived 2+ prior treatments
Prescribed cod liver oil pharmacist filled. i would like to see where my liver level are.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long do visits last?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Phone Call
Most responsive sites:
  1. Evolution Clinical Trials, Inc.: < 24 hours
  2. WR ClinSearch: < 48 hours
  3. National Research Institute - Gardena: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of ION224
2021. "A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of ION224". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04932512.
~42 spots leftby Apr 2025
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