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Lanifibranor for Nonalcoholic Steatohepatitis (NASH) (NATiV3 Trial)
NATiV3 Trial Summary
This trial is testing a new drug, lanifibranor, to see if it can treat adults with a fatty liver disease called NASH, and who also have liver fibrosis stage 2 or 3.
NATiV3 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 2 trial • 247 Patients • NCT03008070NATiV3 Trial Design
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Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
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- I am 18 years old or older.My medications have been the same for the last 3 months.I have been on a stable dose of my diabetes medication for at least 3 months.I have no liver conditions other than NASH or fatty liver.I have had weight loss surgery.I have been diagnosed with conditions related to NASH/Fatty Liver, such as obesity, high cholesterol, high triglycerides, high blood pressure, or Type 2 Diabetes.I have been taking the same dose of Vitamin E (400 IU/day or more) for at least 6 months.I have been diagnosed with NASH or Fatty Liver Disease.
- Group 1: Matching placebo
- Group 2: Lanifibranor (IVA 337) (800 mg/day)
- Group 3: Lanifibranor (IVA 337) (1200 mg/day)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 90 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 72 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 3 Months after you stop receiving the treatment.
Frequently Asked Questions
Are we still able to add new participants to this research project?
"Yes, according to the latest information available on clinicaltrials.gov, this study is still actively recruiting patients. The trial was initially posted on August 19th, 2021 and edited September 7th, 2022. They are 2000 patients needed across 100 different locations."
Are there any other existing research projects that have used IVA337?
"The initial study for IVA337 was done in 2018 at University of Florida. However, as of right now, there have been a total of 18266 completed trials. Additionally, there are 2 live studies being conducted with a large number taking place in Hagerstown, Maryland."
Have researchers looked into this topic before?
"Inventiva Pharma sponsored the first trial for IVA337 back in 2018, which then allowed the Phase 2 drug approval for the medication. Since then, there have been 2 live studies involving IVA337 that are running in 207 cities and 22 countries."
Has the FDA cleared IVA337 for medical use?
"There is both prior clinical data and supporting data from multiple rounds of testing, so the Power team has given IVA337 a score of 3 for safety."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Tampa Bay Medical Research: < 24 hours
- National Research Institute - Panorama City: < 24 hours
- Tandem Clinical Research, Metairie: < 24 hours
Average response time
- < 2 Days
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