Fatty Liver Clinical Trials

As a patient at Cedars-Sinai, you will have access to the latest clinical trials and research for fatty liver. Backed by a respected team of specialists and researchers, our clinical trials aim to further the advancement of diagnosing and treating your fatty liver condition.

Questions? See the Clinical Trials FAQs.


Click below to view clinical trials by areas:

Liver Cirrhosis

Condition:

Nonalcoholic fatty liver disease, cirrhosis, hepatocellular carcinoma

Key Inclusion Criteria:

  • At least 18 years old
  • History of nonalcoholic fatty liver disease with or without cirrhosis or hepatocellular carcinoma diagnosed within the last 6 months

Summary:

This study focuses on patients from Cedars-Sinai and Veteran's Administration Greater Los Angeles Healthcare System who have liver disease. Researchers believe that differences in gut bacteria and the products of these bacteria, together with other factors such as diet and body composition, may help to explain why some people with nonalcoholic liver disease progress to liver cirrhosis or cancer. In this study, researchers will evaluate the differences between biomarkers measured in participants' specimens, clinical data, and questionnaire data to learn more about why nonalcoholic fatty liver disease progresses in some people.

Liver Fibrosis

Condition:

Nonalcoholic steatohepatitis and liver fibrosis

Key Inclusion Criteria:

  • 18-75 years old
  • Evidence of NASH
  • Evidence of Stage 2 or Stage 3 liver fibrosis

Summary:

This study focuses on patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis. Steatohepatitis is a type of liver disease known as fatty liver, where the cells in the liver have abnormal accumulation of fat. Liver fibrosis develops as a consequence of inflammation and buildup of scar tissue in the liver. The purpose of the study is to determine whether an investigational drug called cenicriviroc (CVC) is safe and effective for the treatment of liver fibrosis in patients with NASH. Participants will be randomly assigned to receive either CVC along with information regarding diet and exercise, or a placebo drug along with information regarding diet and exercise.

Nonalcoholic Fatty Liver Disease

Condition:

Nonalcoholic fatty liver disease and/or nonalcoholic steatohepatitis

Key Inclusion Criteria:

  • 18-75 years old
  • Body mass index ≥25 kg/m2
  • Diagnosis of NAFLD within 24 months before Visit 1 of the study

Summary:

This study focuses on patients who have advanced nonalcoholic fatty liver disease and/or nonalcoholic steatohepatitis (NAFLD/NASH). The purpose of the study is to evaluate the investigational use of a drug called saroglitazar magnesium for the treatment of NAFLD/NASH. Researchers aim to learn the effects of saroglitazar on these patients and will test three doses of the drug to determine which is best tolerated and most effective to use. Participants will be randomly assigned to receive one of three doses or placebo (inactive substance).

Nonalcoholic Steatohepatitis (NASH)

Condition:

Nonalcoholic steatohepatitis

Key Inclusion Criteria:

  • 18-75 years old
  • Groups 1-6:
    • Diagnosis of nonalcoholic fatty liver disease
    • Screening FibroTest <0.75
    • Screening magnetic resonance imaging-proton density fat fraction (MRI-PDFF) with ≥10% steatosis
    • Screening magnetic resonance elastography (MRE) with liver stiffness ≥2.88 kPa, or
    • Historical liver biopsy consistent with NASH with stage 2-3 fibrosis, and
    • No documented weight loss >5% between the date of the liver biopsy and screening

Summary:

The purpose of this study is to evaluate the experimental drugs selonsertib (SEL; formerly GS-4997), GS-0976 and GS-9674 for the treatment of non-alcoholic steatohepatitis (NASH). NASH is a disease that results when fat accumulates in the liver. The body’s immune system may respond to the fat by attacking liver cells and over time, scar tissue (fibrosis) forms. SEL, GS-0976 and GS-9674 are intended to reduce inflammation, fibrosis, and fat buildup in the liver. Researchers will assess the safety, tolerability and effectiveness of these drugs in NASH patients.

Condition:

Nonalcoholic Steatohepatitis

Key Inclusion Criteria:

  • 18-75 years old
  • Confirmation of steatohepatitis on a diagnostic liver biopsy
  • Fibrosis Stage 1 or greater and below Stage 4 (according to the NASH Clinical Research Network fibrosis staging system)
  • Body mass index ≤45 kg/m²

Summary:

This study focuses on patients diagnosed with nonalcoholic steatohepatitis (NASH) with fibrosis (recently confirmed by a liver biopsy) or those who are at high risk of having this disease and are willing to undergo a liver biopsy to determine whether they have NASH with fibrosis. The purpose of the study is to evaluate the safety and effectiveness of an investigational drug called elafibranor in these patients. Researchers will assess the efficacy of elafibranor compared to placebo (inactive substance) for the treatment of NASH. The study will also evaluate whether elafibranor reduces the number of patients that will develop further complications from NASH, such as liver cirrhosis.

Condition:

Nonalcoholic steatohepatitis

Key Inclusion Criteria:

  • Liver biopsy consistent with NASH and bridging (F3 fibrosis)
  • Meets specific laboratory parameters at the screening visit

Summary:

This study focuses on patients who have advanced liver fibrosis without cirrhosis as a result of nonalcoholic steatohepatitis (NASH). The study will test an experimental drug called selonsertib for the treatment of advanced liver fibrosis due to NASH. NASH is a disease that results when fat accumulates in the liver; the body’s immune system may respond by attacking the liver cells. Selonsertib is being developed to reduce inflammation and fibrosis in the liver. Researchers will assess the effects, safety and tolerability of selonsertib , as well as whether it can reduce fibrosis and associated complications in patients with cirrhosis and fibrosis due to NASH.

Condition:

Nonalcoholic steatohepatitis

Key Inclusion Criteria:

  • Liver biopsy consistent with NASH and cirrhosis
  • Meets specific laboratory parameters at the screening visit
  • Males and non-pregnant, non-lactating females between 18-70 years old

Summary:

This study focuses on patients who have liver cirrhosis as a result of nonalcoholic steatohepatitis (NASH). The study will evaluate an experimental drug called selonsertib for the treatment of advanced fibrosis of the liver due to NASH. NASH is a disease that results when fat accumulates in the liver; the body’s immune system may respond to the fat by attacking liver cells. Selonsertib is being developed to reduce inflammation and fibrosis in the liver. Researchers will assess the effects, safety and tolerability of selonsertib , as well as whether it can reduce fibrosis and associated complications in patients with cirrhosis and fibrosis due to NASH.

Condition:

Nonalcoholic fatty liver disease and/or nonalcoholic steatohepatitis

Key Inclusion Criteria:

  • 18-75 years old
  • Body mass index ≥25 kg/m2
  • Diagnosis of NAFLD within 24 months before Visit 1 of the study

Summary:

This study focuses on patients who have advanced nonalcoholic fatty liver disease and/or nonalcoholic steatohepatitis (NAFLD/NASH). The purpose of the study is to evaluate the investigational use of a drug called saroglitazar magnesium for the treatment of NAFLD/NASH. Researchers aim to learn the effects of saroglitazar on these patients and will test three doses of the drug to determine which is best tolerated and most effective to use. Participants will be randomly assigned to receive one of three doses or placebo (inactive substance).

Condition:

Nonalcoholic steatohepatitis and liver fibrosis

Key Inclusion Criteria:

  • 18-75 years old
  • Evidence of NASH
  • Evidence of Stage 2 or Stage 3 liver fibrosis

Summary:

This study focuses on patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis. Steatohepatitis is a type of liver disease known as fatty liver, where the cells in the liver have abnormal accumulation of fat. Liver fibrosis develops as a consequence of inflammation and buildup of scar tissue in the liver. The purpose of the study is to determine whether an investigational drug called cenicriviroc (CVC) is safe and effective for the treatment of liver fibrosis in patients with NASH. Participants will be randomly assigned to receive either CVC along with information regarding diet and exercise, or a placebo drug along with information regarding diet and exercise.

Condition:

Nonalcoholic steatohepatitis

Key Inclusion Criteria:

  • At least 18 years old
  • Evidence of NASH based on a liver biopsy obtained no more than 6 months before Day 1 of the study
  • Evidence of Stage 2 or 3 fibrosis or evidence of Stage 1a or 1b fibrosis if accompanied by specific risk factor(s). Note: the study is no longer accepting patients with Stage 1 fibrosis, only Stage 2 or 3.

Summary:

The purpose of this study is to evaluate an investigational drug called obeticholic acid (also known as OCA) and its effect on nonalcoholic steatohepatitis (NASH). OCA is a modified version of a natural compound made in the liver called bile acid. Bile acids are used by the body to help with digestion and have additional effects on liver function. Researchers aim to determine the safety and effectiveness of OCA in delaying or preventing specific medical conditions or health-related issues that can occur in patients with NASH and who have evidence of liver fibrosis (damaged and scarred liver tissue). Patients will be randomly assigned to receive OCA or a placebo (inactive substance).