Weight Management in Nonalcoholic Steatohepatitis
Fatty LiverNonalcoholic steatohepatitis (NASH) is one of the most common chronic liver diseases. The cause of NASH is not completely understood and currently there is no effective treatment for this disease. An effective approach to treatment is needed since without treatment this disease may progress to fibrosis and cirrhosis. Obesity is one of the most important risk factors for NASH and weight reduction is generally recommended as an initial step in its management. However, there are very limited data on the efficacy of weight reduction as a treatment for NASH. Data from uncontrolled trials using poorly defined primary outcome measures and patient populations and nonstandardized weight loss interventions suggest that modest weight loss may improve fatty liver disease. The objective of this project is to conduct a randomized controlled trial of weight reduction in the management of NASH using a combination of diet, exercise, and behavior modification.
Interventional Strategy in Tackling Emerging Non-alcoholic Fatty Liver Disease in Childhood Obesity...
ObesityThe goal of this clinical trial is to investigate the effects of tocotrienol-rich fraction vitamin E supplementation on liver enzymes in overweight and obese children with non-alcoholic fatty liver disease as compared to placebo. The main question[s] it aims to answer are: Does supplementation of tocotrienol-rich fraction vitamin E reduce the level of liver enzymes and improve liver steatosis in non-alcoholic fatty liver disease among overweight and obese children? Does tocotrienol-rich fraction vitamin E supplementation improve the level of liver steatosis by reducing the level of DNA damage? Participants will : consume daily either a dose of 50 mg of tocotrienol-rich fraction (TRF) vitamin E or a placebo for 6 months. Routine clinical assessments include weight, height, waist circumference, and BMI. Fasting glucose, and fasting serum lipid. The following investigations were performed upon recruitment and following 6 months of intervention: (i) liver biomarker and enzymes; (ii) DNA damage; (iii) TNFα, IL-6 and IFN-gamma genes; (iv) Fibroscan.
Study to Evaluate the Effects of a Cytochrome P450 2C19 Inhibitor on the Pharmacokinetics of Miricorilant...
Antipsychotic Induced Weight GainNon-alcoholic Steatohepatitis (NASH)The primary objective of this study is to evaluate the pharmacokinetics (PK) of miricorilant in the presence and absence of the strong cytochrome P450 [(CYP) 2C19] inhibitor, fluvoxamine, in healthy participants. Participants will receive a single dose of miricorilant under fed conditions with a standard breakfast after an overnight fast alone and in combination with once-daily doses of fluvoxamine. Blood samples will be collected at regular intervals for PK and safety analysis between admission and discharge from the clinical unit.
Subcutaneous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic...
Nonalcoholic Steatohepatitis (NASH)Primary Sclerosing Cholangitis (PSC)1 moreCM-101 is developed as treatment for medical conditions involving inflammatory and fibrotic mechanisms such as non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc). In this current study, the IP is tested in healthy male volunteers.
Cigarette Smoking in Non-alcoholic Steatohepatitis
Non-Alcoholic Fatty Liver DiseaseThis non-randomized clinical trial was performed to clarify the effect of cigarette smoking reduction on liver function and some anthropocentric indices in smoker patients with non-alcoholic steatohepatitis.
Multicenter Registry of Nonalcoholic Fatty Liver Disease
Non-Alcoholic Fatty Liver DiseaseNon-alcoholic fatty liver disease (NAFLD) is the most prevalent liver disease worldwide affecting as much as 25% of the world's population. The spectrum of NAFLD ranges from non-alcoholic fatty liver to non-alcoholic steatohepatitis (NASH), the latter being associated with a progressive course towards fibrosis and a higher risk of developing cirrhosis and hepatocellular carcinoma. Patients with type 2 diabetes are particularly at higher risk of developing fibrosis and advanced liver disease. Since NASH and its consequences will only occur in a minority of patients, it is of paramount importance to identify this population to offer them proper care. It is well known that there is a lack of awareness about the potential consequences of NAFLD, not only in the general population but also in the medical community. Patients with NAFLD are frequently lost during follow up and, additionally, approach to these patients is sub-optimal and heterogeneous among physicians. An attractive approach to applying best medical practices to patients with NAFLD is to generate a multicentre registry. Clinical registries comprise a set of systematic collected and stored data focused on a specific condition. The information stored in a registry provides relevant information about a disease and, through a process of error detection, ensures data quality and reliability. A NAFLD registry is an essential tool for providing relevant information such as epidemiological aspects of the disease, outcomes, and treatment effectiveness. As far as we concern, this would be the first registry of NAFLD in our region, a region where the disease behaves in a more aggressive way in comparison with other regions and hemispheres. By generating this registry, we are confident that we will obtain objective information on the characteristic of patients with NAFLD in our region, not only of the disease characteristics but also of social determinants that might influence disease outcomes. By being a prospective study, it allows an adequate patient follow up.
To Evaluate the Safety, Tolerability, PK, and PD of XW003 Injection in Healthy Adult Participants...
Type 2 Diabetes MellitusObesity1 moreXW003 is an acylated human GLP-1 analogue and is being development for diabetes mellitus, obesity and nonalcoholic steatohepatitis (NASH) management. This is a first-in-human (FIH), single-centre, double blind, randomised, SAD and MAD study of XW003 conducted in healthy adult participants. The study is designed to evaluate the safety, tolerability, PK, and PD of XW003 in healthy adult participants.
The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC96719 Tablets in Healthy...
Non-alcoholic Fatty Liver DiseaseNon-alcoholic SteatohepatitisThe Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Non-alcoholic fatty liver disease (NAFLD) treatment drug HEC96719 in Healthy Male and Female Subjects
Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP0678,...
Nonalcoholic SteatohepatitisThis study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single-and multiple-oral doses of ZSP0678 on fasted condition, and characterize PK of ZSP0678 on an empty stomach (fasted condition) and following a high fat, high calorie meal (fed condition) in a 2-period, 2-sequence manner. The study will be conducted in 3 parts (Ascending single dose, multiple dose and food effect). Participants will receive either ZSP0678 or placebo .
Omega 3 Supplementation in Children With Non Alcoholic Fatty Liver
Fatty Liverthis is a prospective, interventional, open-label, randomized study on the efficacy of omega 3 fatty acids supplementation in Egyptian children with non-alcoholic fatty liver disease who had been selected from nutrition and outpatient clinic at Pediatric hospital, Ain Shams University