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Lanifibranor for Nonalcoholic Fatty Liver Disease
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: lanifibranor arm
- Group 2: Placebo
- 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.
Frequently Asked Questions
Do I qualify for participation in this experiment?
"This clinical trial is seeking 54 individuals between the ages of 21 and 75 that have fatty liver disease. Patients must meet this criteria in order to be accepted into the study."
Are there currently open slots for participation in this research endeavor?
"Affirmative. Data on clinicaltrials.gov reveals that this research project, which was initially advertised on August 14th 2018, is currently recruiting participants. Approximately 54 volunteers need to be enlisted from 1 facility."
How many participants have been enrolled in the research so far?
"Affirmative. According to information shared on clinicaltrials.gov, this medical investigation is still searching for suitable candidates. The trial was originally posted in August 2018 and updated last September 2022 . A total of 54 people are expected to enroll at one site location."
How efficacious is lanifibranor for patient wellbeing?
"Lanifibranor has a safety rating of 2, as Phase 2 trials have indicated its potential for being safe but there is not yet any data that proves it to be effective."
Is there an age restriction for participating in this research?
"This trial is available to patients aged 21 and 75. If a person does not meet these criteria, there are presently 224 trials for those under 18, and 1363 clinical studies for adults older than 65 years old."
Has there been any other research exploring the effectiveness of lanifibranor?
"At this moment, there are two ongoing trials examining the efficacy of lanifibranor arm. One is in its third phase and 294 sites across the United States have studies related to it; most notably, Gainesville Florida has a significant presence for these investigations."
Would you describe this trial as being groundbreaking?
"Since 2018, lanifibranor arm has been extensively studied. The first clinical trial was conducted that same year and sponsored by Inventiva Pharma. This initial research led to Phase 2 drug approval from the relevant authorities in due course. Currently, there are two active studies for this medication spanning 207 cities across 22 countries worldwide."
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