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PPAR agonist
Lanifibranor for Nonalcoholic Fatty Liver Disease
Phase 2
Waitlist Available
Led By Kenneth Cusi, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have an age between 21 to 75 years inclusive
Be able to communicate meaningfully with the investigator and legally competent to provide written informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks of treatment
Awards & highlights
Study Summary
This trial is testing if the drug lanifibranor is safe and effective in treating type 2 diabetes and nonalcoholic fatty liver disease. The primary goal is to see if the drug decreases intrahepatic triglycerides.
Who is the study for?
This trial is for adults aged 21-75 with type 2 diabetes and nonalcoholic fatty liver disease. Participants must have uncontrolled diabetes, stable medication use for two months prior, and no recent other drug trials. Pregnant women or those not using effective contraception are excluded, as well as individuals with certain medical conditions or high body mass index.Check my eligibility
What is being tested?
The trial tests lanifibranor's safety and effectiveness in reducing liver fat (IHTG), improving insulin sensitivity, glucose production control, HbA1c levels, lipid profiles, and potential impact on liver fibrosis. Patients will be compared to a placebo group to measure these outcomes.See study design
What are the potential side effects?
Potential side effects of lanifibranor may include muscle issues due to its mechanism affecting various enzymes involved in metabolism. Other risks could involve changes in blood sugar levels or liver-related symptoms but specific side effects will be monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Your age is between 21 and 75 years old.
Select...
You have liver disease with specific blood and chemical test results.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in intrahepatic triglycerides (IHTG) quantified by proton magnetic resonance and spectroscopy (¹H-MRS)
Secondary outcome measures
Change in glycemic control (HbA1c).
Change in plasma biomarkers of liver fibrosis.
Change in plasma lipid profile.
+6 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: lanifibranor armActive Control1 Intervention
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving lanifibranor 800 mg/day.
Group II: PlaceboPlacebo Group1 Intervention
Two arm, randomized (1:1), double-blind, placebo-controlled, 24-week treatment study receiving placebo.
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,349 Previous Clinical Trials
719,772 Total Patients Enrolled
7 Trials studying Non-alcoholic Fatty Liver Disease
554 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Inventiva PharmaIndustry Sponsor
6 Previous Clinical Trials
1,490 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
289 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Kenneth Cusi, MDPrincipal InvestigatorUniversity of Florida
2 Previous Clinical Trials
221 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
221 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a bone condition like osteopenia or another well-known bone disease.You have a heart condition that is not well controlled.You have a history of muscle diseases or currently have a muscle disease.Your diabetes is not well controlled and you are taking specific medications with certain blood sugar levels.You have a current or past infection with hepatitis B or C, or HIV.You are so afraid of small, enclosed spaces that you cannot handle getting a MRI scan.You are taking certain medications that affect specific enzymes in your body.This decision may depend on the investigator.You have a metal implant that stops you from getting an MRI scan.You have a recent history of using weight loss drugs or undergoing certain types of weight loss surgery.Your blood triglyceride levels are higher than 500 mg/dL after fasting.You have a serious illness other than liver disease.You have diabetic ketoacidosis.Your age is between 21 and 75 years old.You have a history of drinking too much alcohol.You have liver disease that is not related to non-alcoholic fatty liver disease (NAFLD).You have liver disease with specific blood and chemical test results.You have too much fat in your liver, as shown by a specific type of scan called Magnetic Resonance and Spectroscopy.Your body mass index (BMI) is greater than 45.You had weight loss surgery less than 5 years ago or took certain drugs that can cause liver problems.You have type 1 or type 2 diabetes and are taking insulin.You have a blood clotting problem or are taking blood thinners.Your test results show certain values that are too high.You have had cancer in the past 5 years or have current cancer.
Research Study Groups:
This trial has the following groups:- Group 1: lanifibranor arm
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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