The Genfit RESOLVE-IT clinical research study is being done to learn whether an oral investigational medication called elafibranor is safe and effective in treating and preventing disease progression and complications in patients who have nonalcoholic steatohepatitis (NASH) with fibrosis. In this study, elafibranor will be compared to placebo. A placebo looks just like the study medication but contains no active ingredients.
RESOLVE-IT is a Phase III study, which means that elafibranor has already been administered to hundreds of patients in Phase II and Phase I clinical trials. Elafibranor was able to demonstrate a sufficient level of efficacy, safety, and tolerability to be authorized by regulatory bodies for testing in the present larger Phase III clinical research study. The Phase IIb study also demonstrated a beneficial effect on cardiometabolic risk factors.
Despite the seriousness and increasing prevalence of nonalcoholic steatohepatitis (NASH), there are currently no approved treatments for the condition. Clinical research studies like RESOLVE-IT may help researchers learn more about much-needed potential treatment options for NASH patients in the future.
There is no guarantee that being in the RESOLVE-IT study will help your NASH with fibrosis, however you will receive all study-related procedures and study medication at no cost. The participation of patient volunteers makes these studies possible.
Speak with the study staff for more information about the potential benefits and risks of study participation.
You may be able to join the RESOLVE-IT study if you:
There are other criteria you must meet to be eligible to participate. The study staff will discuss these with you in more detail.
The investigational medication in the RESOLVE-IT study is called elafibranor. The RESOLVE-IT study will examine whether elafibranor is safe and effective to treat NASH with fibrosis, and also whether it reduces the likelihood of patients developing further liver complications. Elafibranor is considered investigational because it has not yet been approved by the U.S. Food and Drug Administration (FDA) for commercialization to treat NASH with fibrosis.
In the RESOLVE-IT study, each participant will be assigned by chance to receive either elafibranor or placebo. Placebo looks like elafibranor but contains no active ingredients. Participants have a 2 in 3 chance of receiving elafibranor and a 1 in 3 chance of receiving placebo. Neither the participants nor the study staff will know whether a participant is receiving elafibranor or placebo. Study participants will swallow a tablet of either elafibranor or placebo once a day.
Because there are no approved treatments available for your condition, there is no additional risk if you are assigned to receive placebo. Speak with the study staff for more information about elafibranor.
If you qualify for and choose to participate in the RESOLVE-IT clinical research study, your participation will last approximately 6 years. During this time, you will attend study visits where the study doctor and staff will perform study-related procedures and ask you questions about your health. These study visits will occur every 12 weeks for the first 18 months of the study. After that, you will have visits every 6 months at the study site until you complete the study.