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Study on the Effects of Pemafibrate and Tofogliflozin in Patients with Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis

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What is this trial about?

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

This clinical trial is focused on studying a liver condition called Nonalcoholic Steatohepatitis (NASH), which is a type of liver disease that occurs in people who drink little or no alcohol. It involves inflammation and damage to the liver, along with fat buildup. The study is specifically looking at patients with NASH who also have liver fibrosis, which means there is some scarring of the liver tissue. The trial will test the effectiveness and safety of a combination therapy using two medications: pemafibrate (also known by its code name K-877-ER) and tofogliflozin (also known by its code name CSG452). These medications are taken as tablets.

The purpose of the study is to evaluate whether the combination of these medications, or each one individually, is better than a placebo in improving liver health over a period of 48 weeks. Participants will be randomly assigned to receive either the combination therapy, one of the medications, or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment until the study is completed. This helps ensure that the results are not biased.

Throughout the study, participants will have regular check-ups and tests to monitor their liver condition and overall health. The main goal is to see if there is an improvement in liver disease activity and no worsening of liver fibrosis after 48 weeks. The study will also look at other factors, such as the resolution of liver inflammation and fat buildup. Participants will be closely monitored to ensure their safety and well-being during the trial.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, liver biopsy results, and control of any existing diabetes.

    A negative pregnancy test is required for women of childbearing potential.

  2. Step 2

    Medication administration

    The study involves taking medications orally in the form of film-coated tablets.

    Participants may receive either a combination therapy of pemafibrate 0.4 mg once daily and tofogliflozin 20 mg once daily, or one of these medications alone, or a placebo.

    The treatment period lasts for 48 weeks.

  3. Step 3

    Monitoring and assessments

    Throughout the 48-week period, regular monitoring and assessments are conducted to evaluate the effectiveness and safety of the treatment.

    The primary goal is to observe improvements in liver condition without worsening fibrosis, as determined by liver biopsy results.

  4. Step 4

    Completion of the study

    At the end of the 48 weeks, a final assessment is conducted to determine the overall impact of the treatment on liver health.

    The study aims to achieve resolution of liver inflammation and improvement in fibrosis scores.

Who can join the trial?

6 criteria

  • Must be able to understand and follow the study procedures and provide written consent to participate.
  • Must be at least 18 years old.
  • Must have a NAS (a score used to measure liver health) of 4 or higher, with at least 1 point in each part of the score: steatosis (fat in the liver), lobular inflammation (swelling in the liver), and ballooning (liver cell damage) based on a liver biopsy done at the start of the study or within 24 weeks before joining.
  • Must have a fibrosis stage (a measure of liver scarring) of 1 or more but less than 4, based on a liver biopsy done at the start of the study or within 24 weeks before joining.
  • Can have T2DM (Type 2 Diabetes Mellitus) if it is well controlled with stable medication for at least 8 weeks before the first visit. If not having T2DM, must have a fasting blood sugar level of 90 mg/dL or higher at the first visit. A second test is allowed if the first was invalid due to reasons like sample issues or not fasting.
  • Female participants must not be breastfeeding and must have a negative pregnancy test at the first visit if they can have children.

Who cannot join the trial?

10 criteria

  • Patients with other liver diseases besides Noncirrhotic Nonalcoholic Steatohepatitis (NASH) with liver fibrosis cannot participate. This means if you have liver problems not related to NASH, you may not be eligible.
  • Individuals who have a history of alcohol abuse or currently consume excessive alcohol are excluded. This is because alcohol can affect the liver and interfere with the study results.
  • Patients with severe heart problems or uncontrolled high blood pressure are not allowed to join. These conditions can pose additional risks during the study.
  • People with certain types of cancer, especially if they are not well-controlled or are currently being treated, cannot participate. This is to ensure the safety of the participants.
  • Pregnant or breastfeeding women are excluded to protect the health of the mother and baby.
  • Individuals who have participated in another clinical trial within the last 30 days are not eligible. This is to avoid any interference from other treatments.
  • Patients with severe kidney problems are not allowed to join, as this could affect how the body handles the study medication.
  • Anyone with a known allergy to the study drugs or similar medications cannot participate to prevent allergic reactions.
  • People with uncontrolled diabetes, which means their blood sugar levels are not stable, are excluded to ensure their safety during the study.
  • Individuals with a history of drug abuse or addiction are not eligible, as this could affect the study's outcomes.
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Investigated drugs

  • K-001

    is a combination therapy being studied for its effectiveness in treating noncirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis. It combines two medications, K-877-ER and CSG452, to see if they work better together than alone. This therapy is taken once daily.

  • K-877-ER

    is a medication being tested to see if it can help improve liver health in patients with noncirrhotic NASH and liver fibrosis. It is taken once daily and is being compared to other treatments to determine its effectiveness.

  • CSG452

    is another medication involved in the study, aimed at treating noncirrhotic NASH with liver fibrosis. It is also taken once daily and is being evaluated to see how well it works on its own and in combination with other treatments.

What is already known about the treatment

  • K-877-ER

    This medication is administered orally in an extended-release form. It is currently being studied in clinical trials for its effectiveness in treating noncirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis. The main therapeutic indication is to improve liver health in patients with this condition. At the molecular level, K-877-ER works by modulating lipid metabolism, which may help reduce liver fat and inflammation. It is classified as a lipid-modifying agent.

  • CSG452

    This medication is also administered orally and is being evaluated in clinical trials for its potential to treat noncirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis. The primary therapeutic use is to address liver damage associated with this condition. CSG452 functions by targeting specific pathways involved in liver inflammation and fibrosis, aiming to improve liver function. It falls under the category of anti-inflammatory agents.

Investigated diseases

Nonalcoholic Steatohepatitis (NASH) with Liver Fibrosis – This disease is a form of nonalcoholic fatty liver disease characterized by inflammation and damage in the liver, along with fat accumulation. Unlike simple fatty liver, NASH can lead to liver fibrosis, where scar tissue forms in the liver. The progression of NASH involves worsening liver inflammation and fibrosis, which can eventually impair liver function. It is not caused by alcohol consumption and is often associated with obesity, insulin resistance, and metabolic syndrome. The condition can remain stable for years or progress to more severe liver damage. Monitoring and lifestyle changes are typically recommended to manage the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508104-38-00Protocol codeK-001-201Estimated enrolment210 patientsSponsorKowa Research Institute Inc.

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