Study on the Effectiveness and Safety of Lanifibranor for Adults with Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH) and Liver Fibrosis Stages F2/F3
This clinical trial is focused on studying a liver condition called non-alcoholic steatohepatitis (NASH), which is a type of liver inflammation and damage caused by a buildup of fat in the liver. The study is investigating a treatment using a medication called Lanifibranor, which is taken in tablet form. The purpose of the study is to evaluate the effectiveness and safety of Lanifibranor in treating adults with NASH who have a specific stage of liver fibrosis, which is a form of liver scarring.
Participants in the study will be randomly assigned to receive either Lanifibranor or a placebo, which is a substance with no active medication. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo during the initial phase. After this phase, there will be an extension period where all participants will receive the active treatment to further assess the safety of Lanifibranor.
The study will take place over a period of time, with regular check-ups and assessments to monitor the participants’ liver health and overall well-being. The main goal is to see if Lanifibranor can help resolve NASH and improve liver fibrosis, which will be evaluated through liver tissue samples. Participants will be closely monitored to ensure their safety throughout the study.
1Joining the study
Upon joining the study, the patient will be informed about the nature of the study and will provide signed consent. This step ensures understanding and agreement to comply with study procedures.
2Initial assessment
The patient will undergo an initial assessment, which may include a liver biopsy if not recently performed. This assessment confirms the diagnosis of non-alcoholic steatohepatitis (NASH) with specific liver fibrosis stages.
3Double-blind placebo-controlled period (Part A)
During this period, the patient will receive either the medication lanifibranor or a placebo. The medication is administered orally in tablet form. The aim is to evaluate the effect on NASH resolution and liver fibrosis improvement.
4Active treatment extension period (Part B)
Following the initial period, the patient will continue with the active treatment extension. This phase focuses on assessing the long-term safety of lanifibranor.
5Regular monitoring
Throughout the study, the patient will undergo regular monitoring to assess health status and response to treatment. This includes periodic liver function tests and other relevant assessments.
6Completion of study
The study concludes after 72 weeks. The primary goal is to achieve resolution of NASH and improvement in liver fibrosis, as measured by specific scores.
Who Can Join the Study?
Must understand the study, agree to follow the study rules, and sign a consent form before any study activities begin.
Willing to stay in the study even if moving to a new location during the first 72 weeks.
Must be a male or female aged 18 years or older.
If a liver biopsy was done before the study, it must show a diagnosis of Non-alcoholic steatohepatitis (NASH) with liver fibrosis within 7 months before joining the study.
For the main group: A central biopsy must confirm NASH with specific scores: Steatosis score of 1 or more, Activity score of 3 or 4, and Fibrosis score of 2 or 3.
For the exploratory group: A central biopsy must confirm NASH with specific scores: Steatosis score of 1 or more, Activity score of 2 or more with SAF-Inflammation score of 1 or more and SAF-Ballooning score of 1 or more, and any Fibrosis score from 1 to 4.
Model for End-Stage Liver Disease (MELD) score must be 12 or less, unless taking blood-thinning medication.
If taking certain medications, the dose must not change significantly for a specific time before the liver biopsy and must stay the same until the start of the study:
For diabetes medications like GLP1 receptor agonists or SGLT2 inhibitors: at least 3 months.
For Vitamin E at a dose of 400 IU/day or more: at least 6 months.
For Statins: at least 3 months.
For anti-obesity treatments: at least 6 months.
If taking other medications that might affect safety or effectiveness, the dose must not change for at least 3 months before the start of the study.
If overweight or obese, must have tried at least once to lose weight through diet or exercise in the past 6 years.
Weight must be stable for 6 months before the study and between the liver biopsy and the start of the study (no more than 5% change).
Must agree to follow lifestyle changes recommended by the study, which will be monitored throughout the study.
For females who can become pregnant, a negative pregnancy test is required at the start of the study.
Who Cannot Join the Study?
Patients who have other liver diseases besides Non-alcoholic steatohepatitis (NASH) cannot participate. NASH is a liver condition that involves fat buildup and inflammation.
Patients who have had a liver transplant are not eligible.
Patients with significant alcohol consumption are excluded. This means drinking more than a certain amount of alcohol regularly.
Patients with certain heart conditions, such as heart failure, cannot join the study.
Patients with uncontrolled diabetes, which means their blood sugar levels are not well managed, are not allowed to participate.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who are currently participating in another clinical trial are excluded.
Patients with a history of certain cancers, except for some skin cancers, are not eligible.
Patients with severe kidney disease cannot participate.
Patients with certain infections, like hepatitis B or C, are excluded.
Lanifibranor is a medication being studied for its potential to treat non-alcoholic steatohepatitis (NASH), a liver condition characterized by inflammation and damage due to fat buildup. In this clinical trial, lanifibranor is being evaluated for its ability to resolve NASH and improve liver fibrosis, which is the scarring of liver tissue. The study aims to determine both the effectiveness of lanifibranor in treating these liver issues and its safety when used over an extended period.
Non-alcoholic steatohepatitis (NASH) – This is a liver disease characterized by inflammation and damage caused by a buildup of fat in the liver, not related to alcohol consumption. It is part of a group of conditions known as non-alcoholic fatty liver disease (NAFLD). NASH can progress from simple fatty liver to more severe liver damage, including fibrosis, which is the formation of scar tissue. Over time, the liver’s ability to function properly may be impaired due to the ongoing inflammation and scarring. The disease often develops silently, with few or no symptoms in the early stages. As it progresses, individuals may experience fatigue, weakness, and discomfort in the upper right abdomen.
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