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Comparing liquid versus capsule forms of phosphatidylcholine in patients with alcoholic liver disease, chronic hepatitis B, and metabolic liver disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial studies the effectiveness of two forms of Essentiale medication (liquid and capsules) in treating several liver conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Alcoholic Liver Disease, and Chronic Viral Hepatitis B. The main active substance in both forms is phosphatidylcholine, which is derived from soya beans. The purpose of the study is to determine if the liquid form of the medication works as well as the capsule form when added to standard treatment.

During the study, participants will receive either the liquid form of Essentiale (1800 mg), Essentiale capsules, or a placebo. The medication or placebo will be taken daily for 87 days. The liquid medication comes in stick packs containing 1.8g of the substance, while the capsules contain 300 mg each. All participants will continue their regular liver disease treatment throughout the study.

The study will monitor changes in liver disease symptoms such as tiredness, depression, stomach discomfort, sleep problems, loss of appetite, and nausea. The medications and placebos are designed to look, taste, and smell the same so that participants cannot tell which form they are receiving. This helps ensure that the study results are reliable and unbiased.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    You will be evaluated to confirm if you have one of these liver conditions: MASLD/MASH (liver disease related to metabolic problems), alcoholic liver disease, or chronic hepatitis B

    Your symptoms will be assessed using a Global Overall Symptom (GOS) score, which includes: energy loss, depression, abdominal pain, fatigue, sleeping problems, appetite loss, and nausea

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either:

    Essentiale liquid (1800 mg once daily) with placebo capsules, or

    Essentiale capsules (300 mg) with placebo liquid

  3. Step 3

    Treatment period

    The treatment will continue while maintaining your standard care for liver disease

    You will need to take the assigned medication daily

    Regular evaluations of your symptoms will be conducted using the GOS score

    Your quality of life will be assessed using a specific questionnaire for liver disease

    The study will continue until May 2026

  4. Step 4

    Safety monitoring

    Your health will be monitored throughout the study for any side effects

    Any changes in your symptoms or new health issues will be recorded

  5. Step 5

    Additional requirements

    If applicable, you must participate in an alcohol withdrawal program

    You may need to follow specific diet and exercise recommendations

    Women who can become pregnant must use effective contraception during the study and for 30 days after

    Men with partners who can become pregnant must use condoms along with their partner's contraception during the study and for 30 days after

Who can join the trial?

19 criteria

  • Age between 18 and 70 years old
  • Must have symptoms such as:
    • Energy loss (feeling weak)
    • Feeling depressed
    • Stomach pain or discomfort
    • Tiredness
    • Trouble sleeping
    • Loss of appetite
    • Nausea (feeling sick)
    • Must have been diagnosed by a doctor with one of these liver conditions:
      • Fatty liver disease related to metabolic problems
      • Liver disease caused by alcohol
      • Long-term hepatitis B infection
      • Must be currently receiving standard medical care for liver disease
      • Must agree to:
        • Stop drinking alcohol and participate in alcohol treatment if there is a history of alcoholism
        • Follow diet and exercise recommendations if required
        • Must sign an informed consent form
        • Must be willing to follow all study procedures and attend all required visits
        • Must be able to take oral medication
        • For women who can become pregnant: Must use effective birth control (such as hormonal contraceptives or IUD) during the study and for 30 days after
        • For men with partners who can become pregnant: Must use condoms and their partner must use effective birth control during the study and for 30 days after

Who cannot join the trial?

14 criteria

  • Patients under 18 years of age or over 65 years old
  • People with severe liver disease (a condition where the liver is severely damaged and cannot function properly)
  • Individuals with known allergies to any components of the study medication
  • Pregnant or breastfeeding women
  • People currently participating in other clinical trials
  • Individuals with autoimmune diseases (conditions where the body's immune system attacks its own tissues)
  • People with uncontrolled diabetes mellitus (high blood sugar levels that are not well managed)
  • Individuals with serious heart conditions
  • People with severe kidney problems
  • Those who have had major surgery within the last 3 months
  • Individuals with active cancer or undergoing cancer treatment
  • People with history of drug or alcohol abuse within the past 6 months
  • Those unable to provide informed consent
  • Individuals who cannot follow study procedures or attend regular visits
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Investigated drugs

Essentiale® Liquid (EPL liquid) is a medication used to treat various liver conditions. It contains essential phospholipids that help protect and repair liver cells. The liquid form may be easier to take for some patients compared to capsules. Essentiale® Capsules (EPL capsules) contain the same active ingredients as the liquid form, essential phospholipids, which support liver cell function and help in liver repair. The capsule form is a traditional way of taking this medication. Both medications are used in addition to standard of care treatment for patients with liver conditions such as metabolic dysfunction-associated steatotic liver disease (MASLD), metabolic dysfunction-associated steatohepatitis (MASH), alcoholic liver disease, and chronic viral hepatitis B.

What is already known about the treatment

Essentiale - A medication available in both liquid and capsule forms, containing essential phospholipids (EPL) as the active ingredient, used in the treatment of various liver conditions including Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Alcoholic Liver Disease, and Chronic Viral Hepatitis B. The medication works by incorporating phospholipids into damaged liver cell membranes, helping to restore liver cell function and promote liver regeneration. Essentiale is classified as a hepatoprotective agent and is typically administered orally as either liquid (1800 mg) or capsules in conjunction with standard of care treatment, aiming to improve liver health and function in patients with liver diseases.

Investigated diseases

  • Alcoholic Liver Disease

    A condition that develops when years of excessive alcohol consumption damage the liver. The disease begins with fat accumulation in liver cells, which can progress to inflammation and scarring of liver tissue. The liver becomes enlarged and less efficient at performing its vital functions.

  • Chronic Viral Hepatitis B

    A long-term viral infection of the liver caused by the hepatitis B virus. The infection leads to ongoing inflammation of liver tissue, which can last for many years. The virus gradually affects liver cells, causing them to become damaged and leading to changes in liver function.

  • Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

    A condition where excess fat builds up in the liver due to metabolic problems, not related to alcohol consumption. This condition is closely linked to obesity, diabetes, and high blood pressure. When inflammation develops along with fat accumulation, the condition is called Metabolic Dysfunction-Associated Steatohepatitis (MASH). The liver becomes enlarged and its function may gradually decline over time.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521678-32-00Protocol codeLPS17913Estimated enrolment486 patientsSponsorOpella Healthcare Group S.A.S.

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