NASH: Researching A Potential Treatment Option
Nonalcoholic steatohepatitis (NASH) is a liver disease where fat infiltrates the liver and causes inflammation and scarring. NASH evolves from nonalcoholic fatty liver disease. It can lead to cirrhosis of the liver and an increased risk of liver cancer. Complications from the disease can also lead to cardiovascular events and liver disease. Obesity and insulin resistance can lead to an increased likelihood of developing NASH. Currently, there are no approved drug therapies for the treatment of nonalcoholic steatohepatitis.
The NATiV3 Study is a clinical study evaluating an investigational drug as a potential treatment for people living with NASH. If you are interested in learning about the NATiV3 Study and curious if the study may be right for you, please read below. Then, speak with a member of our study.
What You Need to Know About the NATiV3 Study
NATiV3 is a clinical study for adults 18 years of age and older with noncirrhotic NASH and liver fibrosis Stage 2 or 3. The purpose of the study is to evaluate the safety and effectiveness of the investigational drug as a potential treatment option for NASH. The clinical study is also looking to see if there are any improvements in fibrosis or resolution of NASH indicators after taking the investigational drug during the treatment period.
The investigational drug will potentially target three peroxisome proliferator-activated receptors, which could lead to an increase in the ability of the body to regulate insulin, reduce inflammation and improve scarring of the liver caused by NASH.
All eligible study participants will be randomly divided into one of three treatment groups:
- Group 1: Investigational Drug (dosage of 800 mg/day)
- Group 2: Investigational Drug (dosage of 1,200 mg/day)
- Group 3: Placebo (a treatment that resembles the investigational drug but contains no active medicine)
Participants will be randomized at a 1:1:1 ratio, which means you will have a two-thirds chance of receiving the investigational drug and a one-third chance of receiving a placebo.
NATiV3 Study Participation At-A-Glance
Your participation in the study will last for a maximum of 5 to 7 years, depending on when your study participation begins. Participation in the study includes up to 35 visits with the study doctor. Some visits will be conducted by phone while others will occur at the study site. The study is made up of the following phases:
- Screening Phase
- You will meet with the study doctor for tests and assessments to see if you are eligible to participate. The study doctor will review the entire study with you, including what to expect at visits, the tests that will be conducted and the medications you are currently taking. If you are eligible and agree to participate, you will sign an Informed Consent Form that signifies your willingness to be part of the study.
- Treatment Phase
- Part 1 (72 weeks): You will begin taking the investigational drug or placebo by mouth each day, every day, during Part 1. The investigational medication is delivered as three pills that equal a daily dose. During this period, you will have 8 study visits, including 1 phone visit at Week 60. Visits will occur on Day 1, Week 4, Week 12 and then every 12 weeks thereafter until Week 72.
- Part 2 (up to 264 weeks): You will continue to receive the investigational drug or placebo, and you will attend study visits every 12 weeks over the remainder of the clinical study. The study visits will alternate between site visits and telephone visits from Week 84 (telephone) to Week 348 (telephone).
- End of Study
- You will have a final visit with the study doctor to have tests and assessments that will measure the long-term impact of the investigational drug.
For more information about the investigational drug, tests or assessments, please speak with a member of the study team. They are here to help.
You may be able to participate in this clinical study if you are 18 years of age or older and:
- Have a diagnosis of NASH with:
- Steatosis Score: ≥ 1
- Activity Score: A3 or A4
- Fibrosis Score: F2 or F3
- Have a history of at least 1 unsuccessful attempt to reduce body weight by diet and/or exercise within the past 6 years
- Have stable weight for 6 months prior to the Screening Period
Additional eligibility requirements must be met in order for you to participate in the NATiV3 Study. During the Screening Period, the study doctor will review these criteria with you, as well as conduct some tests and assessments to determine your eligibility. All study participants will be asked to review and sign an Informed Consent Form (ICF). Informed Consent is the process of communicating with the study team that leads to an agreement on receiving care as part of a clinical study. The informed consent process is designed to answer any questions you have before the study begins.
What is included in study participation?
All eligible study participants will receive the following at no cost:
- The investigational drug or placebo
- Study-related visits, assessments and tests
- You may also be reimbursed for reasonable study-related travel expenses.
Consider participating in the NATiV3 study assessing the effects that an investigational drug has on NASH resolution, improvement of fibrosis and delaying disease progression.
How can I get involved?
If you meet the listed eligibility criteria and would like to learn more about the NATiV3 study, we would love to hear from you! To speak with the clinical research coordinator, please call (318) 525-3233.