Ongoing Clinical Trials for Hepatic Fibrosis
Currently, there are 3 ongoing clinical trials exploring treatments for hepatic fibrosis, a condition characterized by liver scarring. These studies are investigating different therapeutic approaches including novel medications like Efruxifermin, vitamin-based treatments with Nicotinamide, and repurposing existing cholesterol medications such as Simvastatin to reduce liver damage and improve patient outcomes.
Clinical trial locations
- France
- Germany
- Italy
- Poland
- Spain
- Study on Efruxifermin for Patients with Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH) and Fibrosis
- Study on the Effects and Safety of Nicotinamide for Patients with Type 2 Diabetes and Liver Fibrosis
- Study on Simvastatin for Reducing Liver Fibrosis in Patients with Advanced Alcohol-Related Liver Disease
Study on Efruxifermin for Patients with Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH) and Fibrosis
This trial is testing Efruxifermin, a novel medication designed to help people with Non-Alcoholic Steatohepatitis (NASH) and Metabolic Dysfunction-Associated Steatohepatitis (MASH), both conditions involving fat buildup in the liver that leads to inflammation and scarring.
Who can join: The study is looking for men and women aged 18 to 80 years old. Participants should have a history of Type 2 Diabetes or meet at least two conditions such as obesity, abnormal cholesterol levels, high blood pressure, or high fasting blood sugar. A Body Mass Index (BMI) of 25 or higher is required. If you don’t have a recent liver biopsy meeting certain criteria, you’ll need either a FibroScan liver stiffness measurement above 7.5 kPa or an Enhanced Liver Fibrosis score of 7.7 or higher. You must also have a biopsy-confirmed diagnosis of NASH or MASH with fibrosis stage 2 or 3. Women who can become pregnant must have a negative pregnancy test and agree to use effective contraception during the study.
Who cannot join: You cannot participate if you have other liver diseases unrelated to MASH or NASH, a history of significant alcohol consumption, or other serious health conditions that might interfere with the study. Pregnant or breastfeeding women, those currently in another clinical trial, people who have had a liver transplant, or anyone with a known allergy to the study medication are also excluded.
What the study involves: The main goal is to see if Efruxifermin can resolve NASH or MASH and reduce liver scarring by week 52 of the study. Participants will receive either Efruxifermin or a placebo through an injection under the skin. The study is double-blind, meaning neither participants nor researchers will know who receives which treatment. Regular check-ups will monitor liver health and overall well-being throughout the 52-week treatment period, with a secondary evaluation at week 96. The study is expected to conclude by January 2027.
Investigational drug: Efruxifermin is administered as an injection under the skin. It works at the molecular level by mimicking a natural protein that helps regulate metabolism and reduce liver inflammation and scarring. It is classified as a fibroblast growth factor analog.
Study on the Effects and Safety of Nicotinamide for Patients with Type 2 Diabetes and Liver Fibrosis
This trial examines whether Nicotinamide, a form of vitamin B3, can improve liver health in patients who have both type 2 diabetes and liver scarring.
Who can join: You may be eligible if you are between 18 and 85 years old with a doctor’s diagnosis of NASH. Your Body Mass Index must be between 30 and 40 kg/m2. You must also have type 2 diabetes diagnosed by your doctor, a Fibroscan value higher than 8 kPa (which measures liver stiffness), and an ELF test result greater than 7.7, which is a blood test that assesses liver scarring.
Who cannot join: You cannot participate if you have any other serious liver disease besides fibrosis, if you’ve had a recent heart attack or stroke, or if you have uncontrolled high blood pressure or severe kidney disease. Pregnant or breastfeeding women, those currently in another clinical trial, and people with a history of alcohol or drug abuse are also excluded. Any other medical condition that doctors think might make participation unsafe will also prevent enrollment.
What the study involves: The study aims to evaluate how effective and safe Nicotinamide is for patients with type 2 diabetes and liver scarring. After an initial assessment to confirm eligibility, participants will be randomly assigned to receive either Nicotinamide or a placebo. This is a double-blind study, so neither participants nor researchers will know who receives which treatment. The treatment will be taken orally for 12 months. Regular follow-up visits at 3, 6, and 12 months will include measurements of liver stiffness, fat in the liver, body composition, and blood tests to analyze inflammation and metabolism markers. At the end of 12 months, a final assessment will repeat key tests, and if applicable, a liver biopsy may be performed.
Investigational drug: Nicotinamide is taken orally as tablets or capsules. As a form of vitamin B3, it influences cellular energy production and reduces inflammation, which may help manage liver scarring. Researchers are studying its potential to improve liver health in patients with diabetes.
Study on Simvastatin for Reducing Liver Fibrosis in Patients with Advanced Alcohol-Related Liver Disease
This trial investigates whether Simvastatin, a medication commonly used to lower cholesterol, can help reduce liver scarring in patients with advanced liver damage caused by alcohol consumption.
Who can join: You must be 18 years or older with chronic liver disease related to alcohol, as defined by international guidelines. You need evidence of significant liver damage from a liver biopsy done at the start of the study or within the last 6 months, with a score between 3 and 6 on the Ishak fibrosis scale. Your liver should still be in the compensated phase, meaning it’s functioning reasonably well without major symptoms, with or without signs of increased blood pressure in the liver. Women who can become pregnant must have a negative pregnancy test before joining and agree to use highly effective birth control methods during the study.
Who cannot join: You cannot participate if you have any other serious health conditions that could interfere with the study, if you are pregnant or breastfeeding, or if you have a recent history of alcohol or drug abuse. Those currently in another clinical trial, people with known allergies to Simvastatin or similar drugs, and those with severe kidney disease are excluded. You also cannot join if you have a history of cancer within the last five years (except for certain skin cancers), uncontrolled diabetes or high blood pressure, have had a liver transplant, have HIV or Hepatitis B/C infections, or are unable to comply with study procedures.
What the study involves: The primary goal is to determine if Simvastatin can significantly reduce liver scarring in patients with alcoholic liver disease. After an initial assessment and diagnostic liver biopsy (if needed), participants are randomly assigned to receive either Simvastatin (one 40 mg tablet daily) or a placebo. This is a double-blind study lasting 24 months. Regular follow-up visits at 6, 12, 18, and 24 months will include assessments of liver elasticity using noninvasive methods and blood tests to measure various markers related to liver health and inflammation. At the end of 24 months, a final liver biopsy will evaluate changes in liver scarring. The study will also examine other aspects of health, including changes in gut bacteria and inflammation markers throughout the body.
Investigational drug: Simvastatin is taken orally as a tablet. While primarily used to lower cholesterol by inhibiting an enzyme involved in cholesterol production, researchers are exploring whether it can also reduce liver scarring. This effect on liver cells may help decrease the severity of fibrosis in patients with advanced alcoholic liver disease.
Summary
The three ongoing clinical trials for hepatic fibrosis represent diverse therapeutic approaches to treating liver scarring. Notably, Spain hosts the most trials with all three studies recruiting patients there, while the Efruxifermin trial extends across multiple European countries including Germany, Italy, Poland, France, and Spain, reflecting a broader international research effort.
The trials target different patient populations and underlying causes of liver scarring. The Efruxifermin study focuses on patients with NASH and MASH associated with metabolic conditions, the Nicotinamide trial specifically addresses patients who have both type 2 diabetes and liver scarring, and the Simvastatin study concentrates on those with alcohol-related liver disease. Each study employs a different investigational approach: a novel biologic medication, a vitamin-based therapy, and the repurposing of an existing cholesterol medication, respectively.
All three trials are designed as double-blind, placebo-controlled studies, which helps ensure reliable results. The duration of these studies varies from 12 months to 24 months, with regular monitoring of liver health through various methods including blood tests, imaging techniques, and in some cases, liver biopsies. These trials collectively aim to expand treatment options for patients with liver scarring from different causes.
