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Elafibranor

Elafibranor is an investigational drug being studied in clinical trials for various liver conditions, including nonalcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC). These trials aim to evaluate the safety, efficacy, and pharmacokinetics of elafibranor in different patient populations. The studies range from early phase 1 trials in healthy volunteers to larger phase 3 trials in patients with liver diseases.

Table of Contents

What is Elafibranor?

Elafibranor, also known as GFT505 or IPN60190, is an experimental drug being developed to treat various liver diseases[1][2]. It is taken as an oral tablet and is currently undergoing clinical trials to evaluate its safety and effectiveness[1].

What Conditions Does Elafibranor Treat?

Elafibranor is being studied as a potential treatment for several liver-related conditions:

  • Primary Biliary Cholangitis (PBC): This is a rare, long-term autoimmune disease of the liver. In PBC, the immune system mistakenly attacks the small bile ducts in the liver, leading to damage and scarring[1][3].
  • Nonalcoholic Steatohepatitis (NASH): This is a type of fatty liver disease not caused by alcohol use. In NASH, fat buildup in the liver leads to inflammation and liver cell damage[4][5].
  • Nonalcoholic Fatty Liver Disease (NAFLD): This is a broader term that includes NASH and refers to a range of liver conditions caused by excess fat in the liver not due to alcohol consumption[6].

How Does Elafibranor Work?

While the exact mechanism is still being studied, Elafibranor is believed to work by targeting certain receptors in the liver that play a role in metabolism and inflammation. By activating these receptors, Elafibranor may help to reduce liver inflammation, decrease fat accumulation in the liver, and improve the overall function of liver cells[6].

Clinical Trials and Research

Elafibranor is currently being studied in various clinical trials to assess its effectiveness and safety:

  • Primary Biliary Cholangitis (PBC): Trials are evaluating how well Elafibranor can reduce levels of alkaline phosphatase (ALP), a marker of liver damage, in patients with PBC who haven’t responded well to standard treatments[3][7].
  • Nonalcoholic Steatohepatitis (NASH): Studies are looking at whether Elafibranor can improve liver health in patients with NASH, including reducing liver scarring (fibrosis) and resolving NASH symptoms[5].
  • Nonalcoholic Fatty Liver Disease (NAFLD): Research is examining how Elafibranor affects the composition of fats in the liver of patients with NAFLD[6].

Dosage and Administration

In clinical trials, Elafibranor is typically given as an oral tablet, taken once daily. The most common doses being studied are 80 mg and 120 mg[1][3]. However, it’s important to note that as Elafibranor is still in the research phase, the optimal dosage may change based on ongoing study results.

Potential Side Effects

As with any medication, Elafibranor may cause side effects. The full range of potential side effects is still being studied in clinical trials. Researchers are closely monitoring for any adverse events, changes in laboratory test results, vital signs, and physical examinations[8]. It’s important to remember that not everyone experiences side effects, and the benefits of the medication may outweigh the risks for many patients.

Ongoing Research and Future Directions

Research on Elafibranor is ongoing, with several studies looking at its effects in different patient populations:

  • Studies in elderly patients to understand how age affects the body’s processing of the drug[2].
  • Research in patients with liver impairment to determine if dosage adjustments are needed[9].
  • Investigations in patients with kidney impairment to assess how the drug is processed in these individuals[10].
  • Studies in children and adolescents with NASH to evaluate the drug’s safety and effectiveness in younger populations[4].

These ongoing studies will help researchers better understand how Elafibranor works in different groups of patients and potentially expand its use to treat various liver conditions.

Aspect Details
Drug Name Elafibranor (also known as GFT505, IPN60190)
Main Conditions Studied Nonalcoholic steatohepatitis (NASH), Primary biliary cholangitis (PBC)
Administration Oral tablet, typically 80 mg or 120 mg once daily
Key Outcome Measures Liver enzyme levels (e.g. ALP), liver histology, fibrosis, cholesterol levels, pruritus, fatigue
Trial Phases Phase 1 to Phase 3
Study Populations Healthy volunteers, NASH patients, PBC patients, patients with hepatic or renal impairment
Trial Durations Range from a few weeks to several years
Safety Assessments Adverse events, lab tests, physical exams, ECGs, vital signs

FAQ

  • What is elafibranor? Elafibranor (also known as GFT505 or IPN60190) is an investigational drug being studied as a potential treatment for liver diseases like nonalcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC). It is taken orally as a tablet.
  • What conditions is elafibranor being studied for? Based on the clinical trials data, elafibranor is being studied primarily for nonalcoholic steatohepatitis (NASH) with fibrosis and primary biliary cholangitis (PBC). Some trials are also looking at its effects in patients with hepatic impairment and renal impairment.
  • How is elafibranor administered in the clinical trials? In the clinical trials, elafibranor is administered orally as a tablet. The dosages studied range from 80 mg to 120 mg taken once daily, usually before breakfast with a glass of water.
  • What are some of the main outcomes being measured in the elafibranor trials? Key outcomes being measured include changes in liver enzymes like alkaline phosphatase (ALP), effects on liver histology and fibrosis, impacts on cholesterol levels, changes in symptoms like itching and fatigue, and overall safety and tolerability of the drug.
  • How long do the elafibranor clinical trials typically last? The duration of the trials varies widely. Some early phase studies in healthy volunteers last only a few weeks, while the larger phase 3 trials in patients with liver diseases can last up to 52 weeks or even several years for long-term extension studies.

Ongoing Clinical Trials on Elafibranor

  • Study of Elafibranor for Adults with Primary Biliary Cholangitis

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Czechia Denmark France Greece +8

  • Study on the Safety and Effectiveness of Elafibranor for Adults with Primary Sclerosing Cholangitis

    Not recruiting

    1
    Investigated drugs:
    Germany Italy Portugal Spain

  • Study on Elafibranor for Patients with Primary Biliary Cholangitis Not Responding to Ursodeoxycholic Acid

    Not recruiting

    1 1
    Investigated drugs:
    Belgium France Germany Italy Spain

  • Study of Elafibranor in Adults with Primary Biliary Cholangitis Who Don’t Respond Well to or Cannot Tolerate Ursodeoxycholic Acid Treatment

    Not recruiting

    1 1
    Investigated drugs:
    Czechia France Germany Italy Poland Romania +1

Glossary

  • Nonalcoholic steatohepatitis (NASH): A type of fatty liver disease characterized by inflammation and liver cell damage, which can lead to fibrosis and cirrhosis. It is not caused by alcohol consumption.
  • Primary biliary cholangitis (PBC): A chronic liver disease in which the bile ducts in the liver are slowly destroyed. This can lead to a buildup of bile and other toxins in the liver, eventually causing damage and scarring.
  • Alkaline phosphatase (ALP): An enzyme found in several tissues throughout the body. In liver disease, elevated levels of ALP in the blood can indicate damage to the bile ducts or liver cells.
  • Fibrosis: The formation of excess fibrous connective tissue in an organ or tissue as a result of inflammation, injury, or healing. In the liver, it can lead to scarring and impaired function.
  • Cirrhosis: Advanced scarring of the liver caused by many forms of liver diseases and conditions. It is characterized by the replacement of normal liver tissue with scar tissue.
  • Pharmacokinetics: The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body. This includes measurements like maximum concentration (Cmax) and area under the curve (AUC).
  • Ursodeoxycholic acid (UDCA): A medication commonly used to treat primary biliary cholangitis and other liver conditions. It helps to improve bile flow and reduce liver damage.
  • Pruritus: Severe itching of the skin, which is a common symptom in some liver diseases like PBC.
  • Fibroscan: A non-invasive test that uses ultrasound-based technology to measure liver stiffness, which can indicate the presence and severity of liver fibrosis or cirrhosis.
  • Child-Pugh score: A system used to assess the prognosis of chronic liver disease, mainly cirrhosis. It classifies liver disease into Child-Pugh A (mild), B (moderate), and C (severe) based on clinical and lab parameters.

References

  1. https://clinicaltrials.gov/study/NCT05564208
  2. https://clinicaltrials.gov/study/NCT04171752
  3. https://clinicaltrials.eu/trial/study-of-elafibranor-for-adults-with-primary-biliary-cholangitis-who-do-not-respond-well-or-cannot-tolerate-ursodeoxycholic-acid/
  4. https://clinicaltrials.gov/study/NCT03883607
  5. https://clinicaltrials.gov/study/NCT02704403
  6. https://clinicaltrials.gov/study/NCT03953456
  7. https://clinicaltrials.gov/study/NCT03124108
  8. https://clinicaltrials.gov/study/NCT05543369
  9. https://clinicaltrials.gov/study/NCT03765671
  10. https://clinicaltrials.gov/study/NCT03844555