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GenFit 2: For Patients with NASH and Fibrosis - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about the drug Elafibranor and how it works in people with NASH. We will learn if the drug will keep people with NASH from getting other illnesses.

What is the Condition Being Studied?

NASH with Fibrosis

Who Can Participate in the Study?

Adults age 18 to 75 years old who have been diagnosed with NASH by liver biopsy

Age Group
Adults

What is Involved?

This study is being done in 3 periods: Screening, First Treatment and Long-Term Treatment .

If you join the study, you will start in the Screening Period and:
- Have a screening visit for a physical exam, medical history, vital signs and blood tests
- Have a screening liver biopsy if you've not had one within 6 months

If you are eligible to continue, you will enter the First Treatment Period (72 weeks long) and:
- Be randomized (like the flip of a coin) to one of two treatment Groups:
Group 1 will get Elafibranor (a study drug) -- you will have 2 out of 3 chance of being in this group
Group 2 will get a placebo (a sugar pill) -- you will have a 1 out of 3 chance of being in this group
(Neither you nor your doctor will know which group you are in)
- Have exams and lab work and complete questionnaires
- Have a liver biopsy at 72 weeks
After 72 weeks you will enter the Long-Term Treatment Period and remain in the same treatment group

Study Details

Full Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients with Nonalcoholic Steatohepatitis (NASH) and fibrosis.
Principal Investigator
Protocol Number
IRB:PRO00070557
NCT:NCT02704403
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698