Clinical Trials

The purpose of this study is to investigate the effectiveness and safety of three dose levels of subcutaneous semaglutide for the treatment of patients who have fatty-liver disease not caused by alcoholism.

TARGET-NASH is a longitudinal observational cohort study of patients being managed for NAFLD or NASH in usual clinical practice. TARGET-NASH will create a research registry of patients with NAFLD or NASH within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.

The purpose of this study is to evaluate the effectiveness and safety of three treatment doses of CC-90001 (100 mg, 200 mg and 400 mg PO QD), compared with placebo, in NASH subjects with Stage 3 and Stage 4 fibrosis. This study is designed to assess response to treatment on measures of fibrosis and other efficacy parameters. It will also assess dose response and overall safety.

The first double-blind 72-week treatment period will assess the efficacy and safety of elafibranor on the resolution of NASH without worsening of fibrosis at the intermediate efficacy analysis, followed by a Long-term Treatment Period to assess efficacy on all-cause mortality and liver-related clinical outcomes as measured by the time to first occurrence of any of the listed adjudicated events (all-cause mortality, progression to histological cirrhosis, and the full list of portal hypertension/cirrhosis related events).

The purpose of this study is to assess the pharmacodynamics (PD) of HM15211 after administration of multiple subcutaneous (SC) doses compared to placebo on the liver by proportion of subjects who achieve resolution of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis on NASH Clinical Research Network (CRN) fibrosis score.

Resolution of NASH is defined as non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of 0–1 for inflammation, 0 for ballooning, and any other value for steatosis

The purpose of this study is to investigate the effectiveness of ultrasound imaging for staging liver steatosis, using liver fat content measured by MRI as the reference standard.

The purpose of this research is to create a registry of patients having or at risk for metabolic liver disease for investigations into the molecular pathogenesis of cirrhosis, liver cancer, and end-stage liver disease.

The purpose of this study is to assess a new drug to decrease liver fat in subjects with Non-Alcoholic Steatohepatitis or Non-Alcoholic Fatty Liver Disease.

A variety of liver insults lead to pathological changes in liver architecture that culminate in cirrhosis. While invasive liver biopsy was required to detect cirrhosis, the development of magnetic resonance elastography (MRE) has revolutionized our ability to detect liver fibrosis through non-invasive means that involve measurement of liver stiffness. However, a number of pathological findings occur in liver in response to various insults that precede cirrhosis and are clinically important to identify such as steatosis associated with NASH, inflammation associated with viral hepatitis, and congestion associated with cardiac hepatopathy. Detection of such entities provides essential diagnostic, prognostic, and treatment information ...

The purpose of this study is to identify risk factors and potential predictors for NAFLD and NASH recurrence after liver transplantation.

The purpose of this study is to facilitate discovery and development of novel biomarkers of risk and early detection, etiologic factors relating to liver disease, and novel targeted therapeutic and chemopreventive strategies for liver disease such as PSC, PBC, PLD, NAFLD, NASH, ASH, HCC, donors (non-diseased and diseased) for liver transplant or non-liver diseased subjects scheduled for surgery will serve as controls.