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Fatty Liver clinical trials

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NCT ID: NCT04822181 Recruiting - Clinical trials for Non-alcoholic Steatohepatitis

Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)

ESSENCE
Start date: April 1, 2021
Phase: Phase 3
Study type: Interventional

Semaglutide is a medicine studied in patients with NASH. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries. Participants will either get semaglutide or a dummy medicine - which treatment participants get is decided by chance. Participants will need to inject themselves with medicine under the skin. Participants will need to do this once a week. The study will last for about 5 years. Participants will have up to 21 clinic visits and 9 phone calls with the clinical staff during the study. Some of the clinic visits may be spread over more than one day. Participants with other chronic liver diseases cannot take part in this study. Women cannot take part in the study if they are pregnant, breast-feeding or plan to become pregnant during the study period.

NCT ID: NCT04820036 Recruiting - Obesity Clinical Trials

A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG)

Start date: May 6, 2021
Phase: N/A
Study type: Interventional

Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease worldwide. Affecting approximately one-third of the United States (U.S.) population, the prevalence of NAFLD increases to 90% in patients with obesity. In 25% of patients, NAFLD progresses to a more severe form-non-alcoholic steatohepatitis (NASH)-which further increases the risks of cirrhosis and hepatocellular carcinoma. In 2017, the lifetime costs of caring for NASH patients in the U.S. were estimated at $222.6 billion, with the cost of caring for the advanced NASH (fibrosis stage ≥ 3) being $95.4 billion. It is projected that the number of NASH cases will increase by 63% from 2015 to 2030. Given the weight loss efficacy of Endoscopic Bariatric and Metabolic Therapies (EBMTs), it has been suggested that EBMTs may serve as a novel treatment category for NASH. Previously, the PI and Co-Is studied the effect of Intragastric balloons (IGB)-the oldest EBMT device-on NASH. EUS liver biopsy performed at the time of IGB removal revealed resolution of all NASH histologic features including fibrosis. A follow-up study by a different group showed similar findings. Furthermore, studies have showed the benefits of S-ESG and Aspiration Therapy (AT) on non-histologic features of NASH. Given the greater weight loss experienced after P-ESG compared to IGB (20% vs 10% TWL) and the more reproducible technique and shorter learning curve of the current P-ESG compared to S-ESG, we aim to assess the effect of P-ESG on NASH.

NCT ID: NCT04807868 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

AdventHealth Research Institute Non-Alcoholic Fatty Liver Disease Biobank and Registry (AVAIL)

AVAIL
Start date: April 22, 2021
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to create a resource that will advance research that is focused on discovery of novel therapies, risk stratification, and aggressive interventions for those at highest risk for non-alcoholic fatty liver disease (NAFLD). To achieve this, we will generate a biobank of liver tissue collected during standard of care liver biopsies. Paired blood/urine samples, FibroScan and relevant data will also be collected.

NCT ID: NCT04801849 Recruiting - Clinical trials for Nonalcoholic Steatohepatitis

Vitamin E Dosing Study

VEDS
Start date: August 5, 2022
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, double masked, placebo-controlled, parallel treatment groups dosing trial of Vitamin E in adult nonalcoholic fatty liver disease (NAFLD).

NCT ID: NCT04795219 Recruiting - Hiv Clinical Trials

Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV

Start date: July 19, 2021
Phase:
Study type: Observational

Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions associated with fat accumulation that ranges from benign, non-progressive liver fat accumulation to severe liver injury, cirrhosis, and liver failure. NAFLD is the most common liver disease in US adults and the second leading cause for liver transplantation in the US. The natural history of NAFLD in the general population has been well described, with those with non-alcoholic fatty liver (NAFL, or simple steatosis) destined to have rare incidence of hepatic events compared to those with non-alcoholic steatohepatitis (NASH), who are at high risk for future development of cirrhosis, liver cancer and liver failure. The NASH Clinical Research Network (NASH CRN) was established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in 2002, through the mechanism of RFA-DK-01-025, to further the understanding of diagnosis, mechanisms, progression and therapies of NASH. The NASH CRN effort has resulted in numerous seminal studies in the field. However, NASH CRN studies have systematically excluded persons living with HIV (PLWH), as NAFLD in these persons was thought to be different from that in the general population due to HIV, ART, concomitant medications, and co-infections. This has resulted in major knowledge gaps regarding NAFLD in the setting of HIV. This ancillary study of NAFLD and NASH in Adults with HIV (HIV NASH CRN), HNC 001 goal is to examine the prevalence of hepatic steatosis and NAFLD in a large, multicenter, and multiethnic cohort of PLWH (Steatosis in HIV Study)

NCT ID: NCT04785937 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Accuracy of Imaging Techniques in Diagnosing Steatohepatitis and Fibrosis in NAFLD Patients

ImagingNAFLD
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Non-alcoholic fatty liver disease (NAFLD) is a highly prevalent condition, and when fatty liver is associated with inflammation and hepatocellular injury (steatohepatitis), it can lead to fibrosis, cirrhosis, liver failure and hepatocellular carcinoma. Liver biopsy is the gold standard for NAFLD assessment but has several drawbacks. Several drugs for NASH are now in phase 2-3 trials, and if medical treatments become available, non-invasive tools to identify patients who may benefit from a therapeutic intervention will be strongly needed. Some imaging methods have shown promising potential in fibrosis and NASH diagnosis. This study aims to evaluate the diagnostic accuracy of non-invasive imaging methods, including ultrasound (US) and Magnetic Resonance (MR) techniques, in diagnosing NASH and fibrosis in patients with or at high risk of NAFLD, using liver biopsy as the reference standard. Consecutive patients with a clinical indication for liver biopsy assessment of NAFLD are enrolled in this non-inferiority study. They undergo both a liver US and a multiparametric unenhanced liver MR examination. As reference standard, histological diagnosis of fibrosis and steatohepatitis made according to the fatty liver inhibition of progression (FLIP) algorithm is used. Sensitivity and specificity of imaging parameters alone or in different combinations will be calculated with the aim of finding one or more tests with at least 90% sensitivity/specificity compared to liver biopsy.

NCT ID: NCT04781933 Recruiting - Clinical trials for NASH - Nonalcoholic Steatohepatitis

Interest in "Combo" (a Combination of Dietary Supplements Including Probiotics) in NASH Improvement

ICAN
Start date: January 1, 2023
Phase: N/A
Study type: Interventional

The aim of this bicentre, prospective, placebo-controlled, double-blind, randomized, interventional study is to assess for the first time the effects of a Combo with probiotics and dietary supplements compared to placebo for non-alcoholic steatohepatitis (NASH) patients with mild or severe fibrosis.

NCT ID: NCT04720560 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Role of Regulatory B Cells in the Pathogenesis of Metabolic Associated Fatty Liver Disease

Start date: December 1, 2023
Phase:
Study type: Observational

To evaluate the role of regulatory B cells in the pathogenesis of metabolic associated fatty liver disease patients.

NCT ID: NCT04718051 Recruiting - Liver Diseases Clinical Trials

S.P.PRO LIVER POWDER is Used to Improve Liver and Metabolic Indexes in People With Non-alcoholic Fatty Liver Disease

Start date: January 13, 2021
Phase: Phase 4
Study type: Interventional

With the Westernization of the diet and insufficient exercise, Taiwan's population of obesity, diabetes, and hyperlipidemia has increased in recent years, and the prevalence of the non-alcoholic fatty liver disease has gradually increased. Although weight loss, dietary adjustments, and certain drug treatments can delay the deterioration of the disease; however, weight loss and dietary adjustment are not easy.

NCT ID: NCT04710524 Recruiting - Clinical trials for Nonalcoholic Steatohepatitis

FM101 Efficacy Study in Adults With Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis

Start date: June 10, 2021
Phase: Phase 2
Study type: Interventional

A Randomized Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of FM101 in Adults with Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis