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Ongoing Clinical Trials for Metabolic Dysfunction-Associated Steatohepatitis

There are currently 17 clinical trials investigating new treatments for metabolic dysfunction-associated steatohepatitis, a serious liver condition characterized by fat accumulation, inflammation, and liver damage. These trials are taking place across multiple European countries and are testing various medications aimed at reducing liver inflammation, improving liver fibrosis, and preventing disease progression. (Also known as: Non-Alcoholic Steatohepatitis, NASH, MASH)

Clinical trial locations

Study of Namodenoson Treatment in Patients with Non-Alcoholic Steatohepatitis (NASH) and Liver Fibrosis

This study is evaluating the safety and effectiveness of Namodenoson, an oral capsule medication taken daily, in patients with NASH and mild to moderate liver fibrosis.

Main inclusion criteria: Participants must be at least 18 years old and have confirmed NASH diagnosis through liver biopsy showing a score of at least 4 on the NAFLD activity score. The biopsy must show evidence of fat accumulation, inflammation, and liver cell damage. Liver scarring must be at stage 1, 2, or 3. Participants must also have at least two metabolic conditions such as increased waist size, high triglycerides, low HDL cholesterol, controlled high blood pressure, or high fasting blood sugar. Blood tests must show adequate liver and kidney function, with albumin levels of 3.5 gm/dL or higher, blood clotting test results of 1.3 or less, and kidney function of 50 mL/min/1.73m2 or higher.

Main exclusion criteria: Individuals with a history of significant alcohol consumption, other types of liver disease, advanced liver scarring or cirrhosis, pregnancy or breastfeeding, active cancer or recent cancer treatment, uncontrolled diabetes, severe heart, kidney, or lung disease, body mass index greater than 45, drug or substance abuse within the past 6 months, and inability to provide informed consent are not eligible.

Focus and goals: The study aims to determine if Namodenoson can improve NASH by at least 2 points on a specialized scoring system without worsening liver fibrosis. Participants will take the medication for 36 weeks, during which liver health will be monitored through regular check-ups and blood tests. At the end of the study period, a second liver biopsy will be performed to assess improvements in liver condition and enzyme levels.

Investigational drug: Namodenoson is a synthetic medication that works by interacting with adenosine A3 receptors in the body. It is taken as an oral capsule with a maximum daily dose of 50 mg. The medication is designed to reduce liver inflammation and damage associated with NASH.

Study on Efinopegdutide for Adults with Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis

This trial is investigating efinopegdutide, administered as a subcutaneous injection using a pre-filled syringe, in patients with compensated cirrhosis caused by MASH.

Main inclusion criteria: Participants must have a diagnosis of compensated cirrhosis due to MASH, confirmed by liver tissue test or specific blood and imaging tests. They should either have no history of type 2 diabetes or have well-controlled diabetes with glycated hemoglobin levels of 9% or lower, managed by diet or stable doses of diabetes medications. Participants can be of any sex or gender and must be between 18 and 80 years old. Women of childbearing age must not be pregnant or breastfeeding, must use highly effective birth control methods, have a negative pregnancy test, and agree not to breastfeed during the study and for at least 5 weeks after the last dose.

Main exclusion criteria: The exclusion criteria are not fully detailed in the provided source data.

Focus and goals: The primary objective is to assess the effect of efinopegdutide on reducing liver fat content over 28 weeks. Secondary goals include evaluating safety and tolerability, monitoring changes in liver stiffness using non-invasive methods, and tracking body weight changes.

Investigational drug: Efinopegdutide is a peptide-based medication administered via subcutaneous injection. It works by modulating metabolic pathways involved in fat storage and metabolism, aiming to reduce liver fat content and improve liver health in patients with compensated cirrhosis due to MASH.

Study on Efruxifermin for Patients with Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) or Metabolic Dysfunction-Associated Steatohepatitis (MASH)

This study is evaluating efruxifermin, given as a subcutaneous injection, in patients with compensated cirrhosis caused by NASH or MASH.

Main inclusion criteria: Participants must be males or non-pregnant, non-lactating females between 18 and 80 years old. They must have a history or presence of type 2 diabetes or at least two of the following conditions: obesity, abnormal cholesterol levels, high blood pressure, or high fasting blood sugar. Body mass index must be 25 or higher. Specific FibroScan or ELF score results are required to assess liver stiffness. Some participants must have biopsy-proven compensated cirrhosis with specific liver biopsy scores. Laboratory test results must fall within certain ranges, including albumin, kidney function, blood sugar levels, and stable liver enzyme levels.

Main exclusion criteria: Patients with other serious liver diseases, history of liver transplant, uncontrolled diabetes, significant alcohol or drug abuse in the past year, certain heart conditions, active cancer, pregnancy or breastfeeding, participation in another clinical trial, and severe kidney disease are not eligible.

Focus and goals: The main goal is to determine if efruxifermin can improve liver health by reducing scarring and preventing disease progression. The study aims to see if the treatment can help patients live longer without experiencing serious liver-related problems. Regular check-ups will assess liver function tests and other health markers over several years.

Investigational drug: Efruxifermin is a metabolic modulator administered as a subcutaneous injection. It mimics a natural protein in the body that helps regulate metabolism and reduce liver fat. The medication is designed to improve liver health and function in patients with compensated cirrhosis due to NASH or MASH.

Study on Efruxifermin for Patients with Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH) and Fibrosis

This trial is testing efruxifermin, administered as a subcutaneous injection, in patients with non-cirrhotic NASH and fibrosis.

Main inclusion criteria: Participants must be males or non-pregnant, non-lactating females aged 18 to 80 years. They should have a history or presence of type 2 diabetes or meet at least two of these conditions: obesity, abnormal cholesterol levels, high blood pressure, or high fasting blood sugar. Body mass index must be 25 or higher. Specific laboratory test results are required within certain ranges, including kidney function, blood sugar levels, blood clotting, liver function, and vitamin D levels. Participants must have a biopsy-proven diagnosis of NASH with fibrosis stage 2 or 3 and a certain score on the NAFLD activity score. They must also have stable levels of liver enzymes and be willing to provide written informed consent.

Main exclusion criteria: Patients with other liver diseases not related to MASH or NASH, history of significant alcohol consumption, other serious health conditions, pregnancy or breastfeeding, current participation in another clinical trial, history of liver transplant, known allergy to the study medication or its ingredients, and inability to follow study procedures or attend required visits are not eligible.

Focus and goals: The main goal is to see if efruxifermin can resolve NASH without worsening liver fibrosis by week 52. Secondary evaluations at week 96 will assess long-term effects on NASH resolution and changes in liver fibrosis. The study will monitor liver function, cholesterol levels, and other health indicators throughout the treatment period.

Investigational drug: Efruxifermin is a fibroblast growth factor analog administered as a subcutaneous injection. It works by mimicking the action of a natural protein in the body that helps regulate metabolism and reduce liver inflammation and scarring. The medication is being evaluated for its effectiveness in treating non-cirrhotic NASH with fibrosis.

Study on Liver Fibrosis Assessment Using 68Ga-FAPI-46 Imaging in Patients with Suspected or Confirmed Nonalcoholic Steatohepatitis

This study is evaluating a special imaging technique using 68Ga-FAPI-46 to assess the stage of liver fibrosis in patients with suspected or confirmed NASH.

Main inclusion criteria: Individuals must have recently had a liver biopsy to check for or confirm NASH. They must be of legal adult age and fully informed about the research, having signed an informed consent form. Participants must be part of a social security scheme or be beneficiaries of such a scheme. They must have had a preliminary medical examination suitable for the research. The liver biopsy results must show a specific stage of fibrosis, and the study requires a balanced number of participants with different fibrosis stages, with at least 16 participants in each of the four groups.

Main exclusion criteria: Patients with non-alcoholic or alcoholic hepatic steatosis and those who are part of a vulnerable population are not eligible.

Focus and goals: The primary objective is to determine if the uptake of 68Ga-FAPI-46 in the liver, as seen on a PET/CT scan, varies according to different stages of liver fibrosis. The study will measure the intensity of uptake at sites where liver biopsies were taken to understand how imaging results correlate with actual fibrosis stage. Secondary goals include detecting other areas of fibrosis or inflammation in the body and potentially identifying cancer.

Investigational drug: 68Ga-FAPI-46 is a radiopharmaceutical administered through intravenous infusion. It targets fibroblast activation protein, which is often overexpressed in fibrotic tissues, allowing for enhanced imaging contrast. The substance is used in diagnostic imaging procedures to help visualize and differentiate the intensity of liver fibrosis.

Study on the Safety and Effects of AZD9550 for Overweight and Obese Patients with Non-Alcoholic Steatohepatitis (NASH) with or without Type 2 Diabetes

This study is assessing the safety and tolerability of AZD9550, administered as a subcutaneous injection, in overweight and obese patients with NASH, with or without type 2 diabetes.

Main inclusion criteria: Participants must be males or females who cannot have children, aged between 18 and 65 years. They can have type 2 diabetes or not. If they have diabetes, their blood sugar should be controlled with a diabetes diet and metformin, plus no more than two other treatments, with stable doses for 3 months before screening. Those with diabetes should have an HbA1c between 6% and 9%, while those without should have an HbA1c less than 6.5%. Body mass index should be between 27 and 39.9 kg/m². Participants must use birth control methods following local rules, provide written consent, meet all study requirements within 60 days after signing consent, have suitable veins for multiple blood draws, and be willing to give themselves weekly injections.

Main exclusion criteria: Patients with other liver diseases besides NASH, recent heart attack or stroke, uncontrolled high blood pressure, severe kidney problems, pregnancy or breastfeeding, participation in another clinical trial within the last 30 days, history of drug or alcohol abuse in the past year, certain types of cancer, known allergy to the study medication or similar drugs, and inability to comply with study procedures are not eligible.

Focus and goals: The study aims to evaluate the safety and tolerability of AZD9550 when given in different doses over time. It will monitor how the body processes the drug and its effects on participants’ health, including changes in fasting glucose, insulin, body weight, and liver fat. The study is conducted in several parts, with each focusing on different aspects of the treatment.

Investigational drug: AZD9550 is an investigational drug administered through subcutaneous injections. It is being studied for its potential to treat NASH by targeting specific pathways involved in reducing liver inflammation and fat accumulation. The drug is still undergoing research to determine its safety and effectiveness.

Study of Fecal Microbiota Capsules for Treating Non-Alcoholic Steatohepatitis in Patients

This study is evaluating the effectiveness, safety, and tolerability of lyophilized fecal microbiota capsules, taken orally, in patients with NASH.

Main inclusion criteria: Patients must be between 18 and 75 years old and have a body mass index less than 40 kg/m². They need a confirmed diagnosis of NASH from a liver biopsy done within 24 weeks before joining the study. The NASH histological activity score must be 4 or more, including at least 1 point each for steatosis, liver inflammation, and liver cell damage. Participants must show evidence of liver fibrosis at stage 1, 2, or 3. Women and men who can have children must agree to use birth control methods from the time they join the study until the first follow-up visit.

Main exclusion criteria: Patients with a history of alcohol abuse or alcohol-related liver disease, other liver diseases besides NASH, history of liver transplant, severe heart problems, pregnancy or breastfeeding, inability to swallow capsules, and participation in another clinical trial within the last 30 days are not eligible.

Focus and goals: The study aims to assess if fecal microbiota capsules can resolve NASH without worsening liver fibrosis over 72 weeks. It will monitor changes in liver inflammation, fat content as measured by MRI, and other health markers such as insulin resistance and cholesterol levels. Participants will be observed for any side effects throughout the study.

Investigational drug: Fecal microbiota transfer in capsule form contains healthy bacteria from the stool of a donor. The goal is to introduce beneficial bacteria into the gut to help improve liver health by altering the gut microbiome, which may positively impact liver function and reduce inflammation.

Study on Empagliflozin for Patients with Non-Alcoholic Steatohepatitis (NASH)

This study is evaluating empagliflozin, taken as oral film-coated tablets, in patients with NASH.

Main inclusion criteria: Participants must be able to sign an informed consent form and be between 18 and 75 years old. They must have a confirmed diagnosis of NASH through a liver tissue examination done within the last 6 months. The activity of NASH must be measured by the NAFLD Activity Score. Blood sugar levels must be 80 mmol/mol or lower. Women who can have children must be willing to use at least two methods of birth control.

Main exclusion criteria: Patients with any other serious liver diseases besides NASH, history of alcohol or drug abuse, pregnancy or breastfeeding, participation in another clinical trial within the last 30 days, known allergy to the study medication or its ingredients, and inability to follow study procedures or attend required visits are not eligible.

Focus and goals: The study aims to see if empagliflozin can decrease the histological score of NASH over 48 weeks. Secondary goals include reduction in liver fibrosis and improvements in laboratory results. Participants will have regular follow-up visits to monitor liver health using non-invasive techniques and laboratory tests.

Investigational drug: Empagliflozin is a sodium-glucose co-transporter 2 inhibitor that helps the body remove excess sugar through urine. It is taken once daily as an oral tablet and may lead to weight loss and improved liver health. The medication works by inhibiting a protein in the kidneys that helps reabsorb glucose, leading to improved metabolic function.

Study of resmetirom (MGL-3196) in patients with Non-Alcoholic Steatohepatitis (NASH) to prevent liver damage and disease progression

This trial is testing resmetirom, taken as a film-coated tablet once daily, in patients with NASH to prevent liver damage and disease progression.

Main inclusion criteria: Participants must be willing to provide written informed consent and be 18 years or older. Women who can become pregnant must have a negative pregnancy test, not be breastfeeding, and use two highly effective birth control methods during the study and for 30 days after, or be post-menopausal or permanently sterile. Men who are sexually active must be sterile, practice complete sexual abstinence, or use condoms during sexual activity, and use birth control during the study and for 30 days after. Participants must have suspected or confirmed NASH fibrosis shown by blood tests, FibroScan results, or liver biopsy. Liver fat content must be 8% or higher on special MRI scan during screening.

Main exclusion criteria: People below 18 or above 75 years old, previous liver transplant or on a waiting list, history of cirrhosis with complications, current or recent significant alcohol consumption, presence of other types of liver disease, history of heart failure or significant heart problems, uncontrolled high blood pressure, poorly controlled diabetes with HbA1c above 9.5%, severe kidney disease requiring dialysis, active cancer or cancer treatment within the past 5 years, pregnancy or breastfeeding, participation in another clinical trial within the past 30 days, use of medications that could interfere with the study drug, and history of bariatric surgery within the past 5 years are not eligible.

Focus and goals: The study aims to determine if resmetirom can help resolve NASH and prevent progression of liver damage over 54 months. It will monitor liver tissue samples, liver fat content using MRI, blood substances indicating liver health, and LDL cholesterol levels. After the main study period, some participants may continue in a long-term extension phase.

Investigational drug: Resmetirom is a thyroid hormone receptor beta agonist administered orally once daily. It works by selectively activating thyroid hormone receptor beta in the liver, helping to reduce liver fat accumulation and inflammation without affecting other body tissues. The medication is being evaluated for its ability to resolve NASH and prevent progression to cirrhosis.

Study on AZD2693 for Adults with Non-Cirrhotic Non-Alcoholic Steatohepatitis and PNPLA3 Genetic Marker

This study is evaluating AZD2693, given as a subcutaneous injection, in adults with non-cirrhotic NASH who carry the PNPLA3 rs738409 148M genetic risk allele.

Main inclusion criteria: Participants must be between 18 and 75 years old and carry the PNPLA3 rs738409 148M genetic marker. They must have non-cirrhotic NASH confirmed by liver biopsy showing a NASH activity score of 4 or more, with at least 1 point in each component: steatosis, lobular inflammation, and ballooning. Liver fibrosis must be at stage 2 or 3.

Main exclusion criteria: Individuals with other liver diseases, history of significant alcohol consumption, liver cirrhosis, liver transplant, certain serious heart conditions, uncontrolled diabetes, pregnancy or breastfeeding, current participation in another clinical trial, history of certain types of cancer, and known allergies to the study medication are not eligible.

Focus and goals: The main goal is to assess the effectiveness, safety, and tolerability of AZD2693 in resolving NASH without worsening liver fibrosis over 52 weeks. Secondary goals include assessing improvements in liver fibrosis and overall liver health. Participants will undergo liver biopsies to evaluate treatment effects.

Investigational drug: AZD2693 is an investigational medication currently in Phase 2b clinical trials. It is administered orally and targets specific molecular pathways involved in liver inflammation and fibrosis. The medication is classified as a therapeutic agent for liver diseases, specifically focusing on conditions related to fat accumulation and fibrosis in the liver.

Study on Efinopegdutide and Semaglutide for Adults with Non-Alcoholic Steatohepatitis (NASH) Before Cirrhosis

This trial is evaluating efinopegdutide, administered as a subcutaneous injection using a pre-filled syringe, in adults with NASH before cirrhosis.

Main inclusion criteria: Participants must have a confirmed diagnosis of NASH through liver biopsy showing a NAFLD Activity Score of 4 or higher, including at least 1 point each for steatosis, ballooning, and liver inflammation. Liver biopsy must also show a NASH Clinical Research Network fibrosis score indicating Stage 2 or 3. Participants should not have a history of type 2 diabetes, or if they do, it must be controlled by diet or stable doses of blood sugar-lowering medications. They must be between 19 and 80 years old, and both men and women can participate.

Main exclusion criteria: Patients with other liver diseases, history of liver transplant, significant alcohol or drug abuse in the past year, uncontrolled diabetes, certain heart conditions, pregnancy or breastfeeding, history of cancer in the past 5 years except for some skin cancers, certain infections like hepatitis B or C, participation in another clinical trial, and any other medical condition that study doctors think would make it unsafe to participate are not eligible.

Focus and goals: The primary objective is to evaluate the effect of efinopegdutide compared to placebo on the resolution of NASH without worsening liver fibrosis over 52 weeks. The study will also assess safety and tolerability, monitor changes in body weight, and track any adverse events.

Investigational drug: Efinopegdutide is a therapeutic agent for liver diseases administered as a subcutaneous injection. It works by targeting specific pathways in the body to reduce liver inflammation and fat accumulation. The medication is currently being researched in clinical trials for its potential use in treating NASH.

Summary

The 17 clinical trials for metabolic dysfunction-associated steatohepatitis demonstrate significant international research activity, with the majority of studies concentrated in Western and Central European countries. Spain leads with participation in 11 trials, followed by Germany, France, and Italy, each hosting 7-9 studies. This geographical distribution reflects the established infrastructure for clinical research in these regions and the prevalence of the condition across Europe.

Several medications appear in multiple trials, indicating particular research interest. Semaglutide is being evaluated in three separate studies, while efruxifermin appears in three trials examining both cirrhotic and non-cirrhotic disease stages. Efinopegdutide is being tested in three studies focusing on different patient populations. This concentration of research on specific compounds suggests these medications show promising mechanisms of action for treating liver inflammation and fibrosis.

The trials employ diverse therapeutic approaches, from traditional small molecule drugs to innovative treatments like fecal microbiota transfer. Most studies focus on patients with moderate liver fibrosis stages, though some specifically target those with compensated cirrhosis or carry specific genetic markers like PNPLA3. Treatment durations range from 28 weeks to over 240 weeks, reflecting both short-term efficacy assessments and long-term safety monitoring. The primary endpoints typically focus on NASH resolution without worsening fibrosis, improvements in liver inflammation, and prevention of disease progression to cirrhosis.

Ongoing Clinical Trials on Metabolic dysfunction-associated steatohepatitis

  • Study on Empagliflozin for Patients with Non-Alcoholic Steatohepatitis (NASH)

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia

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