Diagnosed with NASH?
You may qualify for the ION224-CS2 study.
What is the ION224-CS2 study?
The ION224-CS2 study is a clinical research study testing whether an investigational* study drug can safely improve liver health in people with NASH. There are currently no approved drugs for NASH. The ION224-CS2 study is researching a way to meet this currently unmet need.
*Investigational means that the study drug is currently being tested and is not approved by the US Food and Drug Administration (FDA) or any other organization that determines whether drugs are safe.
What is NASH?
NASH is a stage of liver disease in which fat build-up in the liver causes inflammation and damage. For some people, fat build-up does not cause a problem. For others, it leads to NASH, which can lead to permanent liver scarring (cirrhosis) and liver failure.
Nash is more common in people with certain medical conditions, such as obesity, high blood pressure, and type 2 diabetes. If you have any of these conditions, ask your doctor about this study.
What is the study drug?
The study drug (ION224) is designed to reduce accumulated fat in the liver, which may decrease inflammation and liver damage. The study drug is given as an injection (shot) under the skin once every month.
Who can join the study?
You may be able to join the study if you meet these requirements:
- 18 to 75 years old
- Willing to maintain current diet and exercise regimen throughout the study
- Willing to have up to 2 liver biopsies
- Willing to have 4 magnetic resonance imaging (MRI) scans and frequent blood draws for safety monitoring
The study doctor will explain other requirements that also apply.
What can study participates expect?
The ION224-CS2 study will include 3 periods:
Screening period | 2 months
- Informed Consent (read information about the study and sign and date if you agree to participate).
- A liver biopsy, unless you had one in the last 6 months. For a biopsy, a thin needle is inserted through your abdomen into your liver to withdraw a small sample of liver tissue.
- Study health assessments, a blood drawn, and an MRI scan to find out if you can join the study.
Study Drug period | about 12 months
- Random assignment (by chance) to a certain does of study drug or placebo (no active ingredients).
- Participants are at least 2 times more likely to receive the active study drug than placebo.
- Monthly study visits for an injection of study drug or placebo.
- Frequent study visits for health assessments and blood draws. Injections and certain blood draws may be able to take place at your home if this service is available in your area
Follow-up period | about 3 months
- Follow-up visits for health assessments and a final liver biopsy
- Phone calls from study staff asking about your health
How can I get involved?
If you meet the listed eligibility criteria and would like to learn more about the ION224-CS2 study, we would love to hear from you! To speak with the clinical research coordinator, please call (318) 525-3233