Active clinical trials for "Non-alcoholic Fatty Liver Disease"

This clinical study is designed to evaluate the safety and immune modulatory effects of oral administration of the study drug anti-CD3 monoclonal antibody (MAb) to subjects with the metabolic syndrome.

Non-alcoholic fatty liver disease (NAFLD) is a clinical/biochemical condition associated with the metabolic syndrome. As the disease stems from excess calorie intake and lack of physical activity, the correction of unhealthy lifestyles is the background of any prevention and treatment strategy

The main research questions are: In hypogonadal men with non-alcoholic steatohepatitis (NASH), does Testosterone Replacement Therapy (TRT), given for 12 months improve severity of steatosis on liver biopsy (Primary Question)? improve severity of associated steatohepatitis on liver biopsy? reduce liver fat content as assessed by proton Magnetic Resonance Spectroscopy (1H-MRS)? The work proposed here is an open pilot study of 10 patients, the main aim of which is to assess the effect size of TRT in regard to these end points (regarding which there are no published data), thereby allowing power calculations for a more definitive phase II trial. Other aims would be assessing recruitment and consent rates, which would also inform the design of the larger study.

This study is to evaluate the effects of Rosiglitazone, insulin sensitizer and alpha-lipoic acid, antioxidant on patients with pathologically proved NASH (non-alcoholic steato-hepatitis).

The primary objective of this study is to evaluate the safety and tolerability of selonsertib, firsocostat, cilofexor, fenofibrate and/or Vascepa® in adults with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH).

The purpose of this study is to determine the effects of a low carbohydrate diet vs a low fat diet on improvement in aminotransferases, hepatic fat infiltration, markers of inflammation, insulin resistance, and body composition in obese adolescents with non-alcoholic fatty liver disease (NAFLD).

This is a phase I/IIa, randomized, single-blind, placebo-controlled, multiple-ascending dose study conducted at a single site. The study plans to include up to approximately 46 evaluable subjects with Type 2 Diabetes Mellitus (HbA1c 7-11%) and Non-Alcoholic Fatty Liver disease (liver fat content > = 8%) on metformin monotherapy. Three initial cohorts are planned: Cohort 1: 6 subjects receiving AZD4076 and 4 subjects receiving placebo Cohort 2: 12 subjects receiving AZD4076 and 10 subjects receiving placebo Cohort 3: 10 subjects receiving AZD4076 and 10 subjects receiving placebo, with the possibility to add additional subjects if drop-out rates are higher than expected Pending review by SRC, an additional 2 cohorts, each consisting of 18 evaluable subjects may be included in the study. The primary objectives of this clinical trial are to investigate the safety and tolerability of AZD4076 following subcutaneous administration of multiple ascending doses; to assess the effect of AZD4076 on whole body insulin sensitivity using hyperinsulinemic euglycemic clamp with tracer technique; and to assess the effect of AZD4076 on liver fat content using magnetic resonance imaging. Secondary objectives of this trial are to characterize multiple dose PK of AZD4076 and its longmer and shortmer metabolites and assess the time required to reach steady state and the degree of accumulation; to assess the efficacy of AZD4076 on 24-hour glucose; and to assess the effect of AZD4076 on homeostatic model assessment insulin resistant (HOMA-IR) and Matsuda index.

The hypothesis of this study was that ginger supplement consumption can be introduced as a new therapeutic strategy for non-alcoholic fatty liver disease through the improved body antioxidant activity, reduced levels of inflammation and insulin resistance. A randomized double-blind study was designed to evaluate this hypothesis in order to examine the effectiveness of ginger supplement in patients with non-alcoholic fatty liver disease.

To study the frequency of obstructive sleep apnea (OSA) and continuous positive airway pressure (CPAP) treatment response in patients with non-alcoholic fatty liver disease (NAFLD). It is hypothesized that CPAP treatment may improve the activities of NAFLD in those with concomitant OSA. A screening study for OSA followed by a randomized controlled trial of patients with biopsy proven NAFLD being followed up at the hepatology clinic. Home sleep study, Epworth sleepiness score (ESS), paired proton magnetic resonance spectroscopy (MRS), transient elastography by fibroscan, serum cytokeratin-18 fragment, liver function tests and liver biopsy (only for those with fibroscan evidence of advanced liver fibrosis). Patients with confirmed symptomatic OSA will be randomized to receive auto CPAP or subtherapeutic CPAP as control over 6 months. Primary outcome: changes in intrahepatic triglyceride content (IHTG) measured by proton-MRS after 6 months of auto CPAP versus subtherapeutic CPAP.

This study will evaluate the safety and tolerability of escalating single- and multiple-oral doses of cilofexor, and characterize the single- and multiple-dose pharmacokinetics (PK) of cilofexor. The study will be conducted in 3 parts (Part A, Part B, and Part C). Participants will receive either cilofexor or cilofexor placebo. Part A will proceed in 4 prespecified staggered cohorts. Within each cohort, the cumulative, blinded safety data will be evaluated for dose escalation from single-dose (Period 1) to multiple-dose (Period 2). Based on the available safety, pharmacokinetics, and/or pharmacodynamics (PD) data from cohorts in Part A and Part C (if applicable), total daily doses and frequency of dosing will be chosen for the cohorts in Part B. Parts B and C will consist of adaptive cohorts and may be initiated in parallel. Part B cohorts may be initiated in parallel with cohorts in Part A if the total dose under evaluation is at or below a dose already evaluated. This study is partially blinded (no one is blinded on Day -1).