Efficacy, Safety and Mechanism of Action of Lanifibranor (IVA337) in Patients with Type 2 Diabetes (T2DM) and Nonalcoholic Fatty Liver Disease (NAFLD)

Purpose

About two-thirds of people who are overweight, obese, or have type 2 diabetes may accumulate too much fat in their liver, which can cause long term damage that leads to a serious condition called cirrhosis.

The purpose of this study is to learn whether you have too much fat in your liver, and offer a potential treatment if you do.

To learn more about the study and to see if you qualify, fill out the online form here with your contact information or continue scrolling.

Want to reach out to the study team directly? Contact Amanda Slater at Amanda.Slater@medicine.ufl.edu or 352.294.4896.



You can participate if you...

  • Are between the ages of 21 – 75 years old
  • Are overweight or obese OR
  • Have been diagnosed with Type 2 diabetes


Here’s what you’ll be asked to do…

First, the study team will need to confirm whether or not you are eligible to participate in the study.

You can fill out the online form here with your contact information or reach out to Amanda Slater at Amanda.Slater@medicine.ufl.edu or 352.294.4896.

The study team will then reach out to you and ask you a few questions to see if you are eligible for the next step. If so, you may be asked to come to campus and begin the study and potential treatment.

The entire participation in the study will take about 34 – 36 weeks.



About the treatment

This study is seeking to establish the safety, efficacy and mechanism of action of a drug called Lanifibranor.

The research team believes that treatment with Lanifibranor will significantly decrease fat cells in the liver.

Not everyone in the study will get Lanifibranor, because you will be put into a treatment group by chance (like flipping a coin). As a result, you will either receive Lanifibranor or placebo.

Placebo looks just looks like Lanifibranor and is given in the same way but has no active drug in it. The chance you will get Lanifibranor is 1 out of every 2 patients.

Questions about Lanifibranor? Contact Amanda Slater:



Age

18 to 65
65 and over

Gender

Male
Female

Monetary compensation

Yes

Can be done from home

No

Keywords

Diabetes, Diabetes - resources, Obesity

Principal Investigator

Kenneth Cusi, MD

Contact Information

Amanda.Slater@medicine.ufl.edu

352.294.4896


Be an Informed Participant

Before deciding to participate in a research study, take time to learn about clinical research, how it's conducted and your rights as a research participant. Following are some helpful resources from independent sources. Always remember that a clinical research study is research, not treatment.

Know Who to Contact

  • Eligibility: For questions about a specific study and who is eligible to participate, call or email the contact person listed for that study.
  • Your Rights: For questions about your rights as a research participant, contact the UF Institutional Review Boards at 352-273-9600.
  • Feedback: For general questions or feedback about study listings, email the UF Clinical and Translational Science Institute at UFStudies@health.ufl.edu.

Other Resources

  • HealthStreet: Health-focused services, classes and events, and opportunities to participate in research.
  • ResearchMatch.org: Join a national registry of volunteers willing to be contacted about research studies.

For Research Teams