Liver Fibrosis Clinical Trials

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Emily Wagner

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Editor's note: This article contains information that goes out-of-date quickly. While we strive to maintain currency, research trends can sometimes move faster than our editorial team. We still feel this information is important for those considering participation in clinical trials. Please consult with your doctor or the investigative team running any particular research study for the most up-to-date information.
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Liver fibrosis is a liver disease complication that’s diagnosed when the healthy tissue in your liver becomes replaced with stiff scar tissue. This may be caused by viral infections, excess alcohol consumption, or being overweight or obese. If left untreated, your liver will lose its ability to function, and you may develop severe liver scarring (cirrhosis).1

Currently, doctors use medications to treat the underlying cause of liver fibrosis to help manage inflammation and scarring. However, once enough damage is done to the liver, it may be irreversible. Early diagnosis and treatment are vital to preventing cirrhosis.2

As doctors and researchers continue to learn more about liver fibrosis and cirrhosis, they’re finding new ways to diagnose and treat them. These experimental tools and medications must first go through clinical trials to prove they’re safe and effective. Volunteers with different stages of liver fibrosis and cirrhosis join these studies in hopes of advancing medicine.

The following clinical trials are just some of the current research studies on liver fibrosis.

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What is Liver Fibrosis?Treatments for Liver Fibrosis

New Treatments and Diagnostic Tools for Liver Fibrosis

Liver fibrosis is caused by several different diseases, including nonalcoholic fatty liver disease (NAFLD, caused by obesity or diabetes) and primary sclerosing cholangitis (a disease that blocks the bile ducts). One complication of NAFLD is nonalcoholic steatohepatitis (NASH), which causes inflammation and fibrosis due to fat buildup in the liver.1

Several new treatments are being studied to treat NASH and prevent further damage to the liver. This is important because once your liver is too damaged and begins to fail, the only treatment option is a liver transplant. People may wait months to years to receive a transplant as there are not enough donors to meet their needs.3

As a result, there’s an unmet need for medications that target inflammation and scar tissue formation at the source to prevent liver fibrosis and damage. Examples of treatments currently being studied include:

  • HTD1801: A first-in-class (brand new) type of drug that prevents fat accumulation in the liver; it’s being studied in adults with NASH and prediabetes or type 2 diabetes4
  • Rencofilstat: A drug that binds to liver enzymes to block inflammation and fibrosis; it’s being studied in adults with advanced liver fibrosis and NASH5
  • Lanifibranor: A drug that may help limit fat accumulation and treat fibrosis by activating PPAR proteins; it’s being studied in adults with NASH and moderate liver fibrosis6

Currently, the only way to definitively diagnose liver fibrosis is through a biopsy. During this procedure, your doctor will take a small piece of liver tissue to look at under a microscope. Imaging tests using ultrasound or magnetic resonance imaging (MRI) can show changes in the shape and size of your liver, but they may not always detect scar tissue and inflammation.

With this, doctors and researchers have begun developing new diagnostic imaging tools for liver fibrosis, cirrhosis, and NASH. These methods are less invasive than a biopsy and give almost immediate results.7-9

Previously Approved Treatments

Doctors and researchers have also found new ways to treat liver fibrosis with previously approved medications for other diseases. Medications for Type 2 diabetes, including SGLT2 inhibitors and DPP-1 agonists, are being investigated in NASH. Statins are medications used to treat high cholesterol levels. They’re currently in clinical trials to see if they’re a safe and effective treatment for NASH. Other studies are also investigating whether they can reduce the risk of hepatocellular carcinoma (HCC), a liver cancer that develops as a complication of liver fibrosis.11-13

Joining a Liver Fibrosis Clinical Trial

Find Clinical Trials Near Me

Interested in clinical trials? Simply search by postal code and type of condition to see what’s going on in your area.

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If you’re interested in joining a liver fibrosis clinical trial, you can start by looking for studies taking place near you. You must meet certain qualifications to participate — these are set by the study investigators to ensure that data collected during the trial are accurate and that participants are safe. To join a liver fibrosis clinical trial, you may have to:

  • Meet certain age and health requirements
  • Have moderate to severe liver fibrosis defined by a staging system
  • Have certain liver enzyme, cholesterol, and/or blood sugar levels

People have their own reasons for joining clinical trials. Choosing to take part in a clinical trial is a major decision. Whatever your choice is, it should be in your best interest.

Last updated: 05/15/2024

Medical Disclaimer: The information provided in this article is not a substitute for the advice of qualified healthcare professionals. While we strive to publish accurate information, it is not possible to cover all potential scenarios, including drug or treatment effects, interactions, or usage. You should not rely solely on this article to determine whether a particular treatment, drug, or clinical trial is suitable for you or any other individual. Always consult a healthcare professional before starting or changing any treatments.

Sources

  1. Bataller R, Brenner DA. Liver fibrosis. J Clin Invest. 2005;115(2):209-218.
  2. Tan Z, Sun H, Xue T, et al. Liver fibrosis: Therapeutic targets and advances in drug therapy. Front Cell Dev Biol. 2021;9:730176.
  3. Mayo Clinic. Liver Transplant. October 20, 2022. Accessed from: https://www.mayoclinic.org/tests-procedures/liver-transplant/about/pac-20384842
  4. ClinicalTrials.gov. HTD1801 In Adults with Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes (CENTRICITY). January 18, 2023. Accessed from: https://clinicaltrials.gov/ct2/show/NCT05623189
  5. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Rencofilstat in Subjects with NASH and Advanced Liver Fibrosis (ASCEND). December 8, 2022. Accessed from: https://clinicaltrials.gov/ct2/show/NCT05402371
  6. ClinicalTrials.gov. A Phase 3 Study Evaluating Long-term Efficacy and Safety of Lanifibranor in Adult Patients with (NASH) and Fibrosis 2 (F2)/Fibrosis 3 (F3) Stage of Liver Fibrosis (NATiV3). January 25, 2023. Accessed from: https://clinicaltrials.gov/ct2/show/NCT04849728
  7. ClinicalTrials.gov. The Availability of the Enhanced Liver Fibrosis (ELF) Test Affects the Rate of Diagnosis of Nonalcoholic Steatohepatitis (NASH) with Fibrosis in Patients Referred to Hepatology. May 11, 2022. Accessed from: https://clinicaltrials.gov/ct2/show/NCT05370053
  8. ClinicalTrials.gov. Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286. January 9, 2023. Accessed from: https://clinicaltrials.gov/ct2/show/NCT05180162
  9. ClinicalTrials.gov. A Study to Evaluate Liver Stiffness with Shear Wave Elastography. November 16, 2022. Accessed from: https://clinicaltrials.gov/ct2/show/NCT05097963
  10. Chalasani N, Younossi Z, Lavine J et al. The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 67(1):p 328-357, January 2018.
  11. ClinicalTrials.gov. Safety and Efficacy of Atorvastatin v. Placebo on HCC Risk (TORCH). December 19, 2022. Accessed from: https://clinicaltrials.gov/ct2/show/NCT05028829
  12. ClinicalTrials.gov. Simvastatin in Preventing Liver Cancer in Patients with Liver Cirrhosis. October 24, 2022. Accessed from: https://clinicaltrials.gov/ct2/show/NCT02968810
  13. ClinicalTrials.gov. Multi-Center Study of the Effects of Simvastatin on Hepatic Decompensation and Death in Subjects Presenting with High-Risk Compensated Cirrhosis (SACRED). June 22, 2022. Accessed from: https://clinicaltrials.gov/ct2/show/NCT03654053
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