160 Participants Needed

ION224 for Non-alcoholic Fatty Liver Disease

IP
SC
Overseen ByStudy Coordinator
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

You may need to stop taking certain medications, especially if they are associated with non-alcoholic fatty liver disease or if you are not on a stable dose. It's best to discuss your specific medications with the trial team to see if any changes are needed.

What makes the drug ION224 unique for treating non-alcoholic fatty liver disease?

The drug ION224 is unique for treating non-alcoholic fatty liver disease because there are currently no standard approved therapies for this condition, making any new treatment option potentially novel and significant.12345

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion 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.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

8 weeks

Treatment

Participants receive ION224 or placebo by subcutaneous injection every 4 weeks for up to 49 weeks

49 weeks

Post-Treatment

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

  • ION224
  • Placebo
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

Ionis Pharmaceuticals, Inc.

Lead Sponsor

Trials
151
Recruited
27,800+
Dr. Brett P. Monia profile image

Dr. Brett P. Monia

Ionis Pharmaceuticals, Inc.

Chief Executive Officer since 2020

PhD in Pharmacology from the University of Pennsylvania, BSc in Molecular Biology and Analytical Chemistry from Stockton State College

Dr. Eric Bastings profile image

Dr. Eric Bastings

Ionis Pharmaceuticals, Inc.

Chief Medical Officer

MD

Findings from Research

In a study of 187 participants with nonalcoholic steatohepatitis (NASH) receiving placebo treatment, 20% showed a significant reduction in liver fat content (PDFF) after 12 weeks, highlighting a notable 'placebo effect' that can impact trial outcomes.
The analysis revealed an average decrease of 2.3 units in absolute PDFF values after 24 weeks of placebo treatment, suggesting that future clinical trials should account for this effect when calculating sample sizes.
MRI Quantification of Placebo Effect in Nonalcoholic Steatohepatitis Clinical Trials.Nedrud, MA., Chaudhry, M., Middleton, MS., et al.[2023]

References

MRI Quantification of Placebo Effect in Nonalcoholic Steatohepatitis Clinical Trials. [2023]
Impact of sodium glucose cotransporter 2 inhibitor on histological features and glucose metabolism of non-alcoholic fatty liver disease complicated by diabetes mellitus. [2020]
Pathogenesis and therapeutic approaches for non-alcoholic fatty liver disease. [2022]
Non-alcoholic fatty liver disease. [2022]
Efficacy of probiotics in non-alcoholic fatty liver disease in adult and children: A meta-analysis of randomized controlled trials. [2020]
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