A Study to (1) Compare How BI 456906 is Taken up in the Body of Healthy People and People With Liver...
HealthyLiver Diseases1 moreThis study is open to adults who have different levels of liver problems and adults who are healthy. People with or without overweight or obesity can take part. This study has 2 parts. The purpose of Part 1 is to find out whether having liver problems influences how BI 456906 is taken up in the body. The purpose of Part 2 is to find out whether having liver problems influences how people with overweight and obesity tolerate different doses of BI 456906. In Part 1, participants get a single injection of BI 456906 under their skin and stay at the study site for 2 nights afterwards. They are in the study for about a month. During this time, they visit the study site about 8 more times. The doctors compare the amount of BI 456906 in the blood of healthy people and people with liver problems. In Part 2, participants get 1 or 2 injections of BI 456906 once a week under their skin for 28 weeks. At the beginning, they get lower doses of BI 456906. Over time, they get higher doses until they reach a certain dose of BI 456906. This dose is then maintained until the end of the treatment. Participants in Part 2 are in the study for about 7 months. During this time, they visit the study site about 16 times and get about 15 phone calls from the site staff. The doctors record the number of people with health problems that could have been caused by treatment with BI 456906. They compare the results between participants with liver problems and those without liver problems. In both parts, doctors also regularly check participants' health and take note of any unwanted effects.
Growth Hormone in Decompensated Liver Cirrhosis
Liver CirrhosisFibrosis5 moreGlobally, cirrhosis and liver cancer carries a huge burden and accounts for about 3.5% (2 million) of all deaths every year. Once decompensated, i.e. development of ascites, variceal bleed, encephalopathy, and jaundice, the life expectancy is markedly reduced to a median of two years. The definitive treatment in this stage, i.e., liver transplantation is limited by cost, lack of donors, and life-long immunosuppression. In addition to complications due to portal hypertension and hepatic insufficiency, decompensated cirrhosis is associated with malnutrition, sarcopenia, immune dysfunction, and impaired regeneration. Patients with cirrhosis are growth hormone (GH) resistant, with reduced insulin-like growth factor, which are linked to malnutrition and poor liver regeneration in cirrhosis. Diverse preclinical and clinical investigations in vitro and in vivo, have shown a benefit of GH in GH deficient, elderly and HIV positive patients. GH therapy in cirrhosis has been shown to improve nitrogen economy and to improve the GH resistance in a small pilot study by Donaghy et al. Also, GH therapy of short duration has shown to increase IGF1 levels, IGFBP-3 levels in patients of cirrhosis. GH therapy has also been shown to improve liver regeneration and protein synthesis after hepatectomy in patients of HCC with cirrhosis. However, there is a scarcity of data on clinical impact of long term administration of GH therapy in patients of cirrhosis. Hence, we undertook the present study to study the effect of growth hormone on clinical outcomes, malnutrition, immune cells and liver regeneration in patients with cirrhosis.
A Study to Test Whether BI 685509 Alone or in Combination With Empagliflozin Helps People With Liver...
Liver DiseasesHypertension1 moreThis study is open to adults with liver cirrhosis caused by hepatitis B, hepatitis C or nonalcoholic steatohepatitis (NASH). People can join this study if they have high blood pressure in the portal vein (main vessel going to the liver). The purpose of this study is to find out whether a medicine called BI 685509 taken alone or in combination with a medicine called empagliflozin helps people with this condition. Participants take BI 685509 as tablets twice a day for 8 weeks. Half of the participants with NASH who also have type 2 diabetes take empagliflozin as tablets once a day in addition to BI 685509. Participants are in the study for about 3 months. During this time, they visit the study site about 10 times. At 2 of the visits, the doctors check the pressure in a liver vein to see whether the treatment works. This is done with a catheter (a long thin tube) and gives information about the pressure in the portal vein. The doctors also regularly check participants' health and take note of any unwanted effects.
Saroglitazar Magnesium 4 mg in the Treatment of NAFLD in Women With PCOS (EVIDENCES VII)
Non-alcoholic Fatty Liver Disease in Women With PCOSThis is a multicenter, phase 2A, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Saroglitazar Magnesium in women with well characterized PCOS.
Change of Adipose Tissues and Triglyceride After Bariatric Surgery or Life-style Intervention
Non-Alcoholic Fatty Liver DiseaseObesity6 moreThe study is aimed To quantify the change of adipose tissues, triglyceride in liver and pancreas and cholesterol after lifestyle intervention or bariatric surgery. To test the hypothesis that Brown fat is an independent biomarker for the development of Non Alcoholic Fat Liver Disease (NAFLD) To study the association among Brown fat, NAFLD and obesity.
Super HEROES: Searching How the Extract Rebaudioside Occludes Excess Steatosis
Non-Alcoholic Fatty Liver DiseaseIn order to determine whether rebaudioside consumption can be used as a treatment for adolescents with Non-alcoholic Fatty Liver Disease (NAFLD) by demonstrating a decrease in alanine aminotransferase (ALT) levels participants will be randomized to receive one of three 8-week liquid diet interventions: Standard of care Water delivery Water with Rebaudioside (stevia natural sweetener)
Optimal Exercise Frequency to Reduce Liver Fat in Centrally Obese Adults With Non-Alcoholic Fatty...
Non-Alcoholic Fatty Liver DiseaseObesityThis study aims to examine the comparative effectiveness of different exercise frequencies (once-a-week vs. thrice-a-week) for reducing liver fat in centrally obese adults with non-alcoholic fatty liver disease (NAFLD), with weekly exercise volumes aligned with the World Health Organization's physical activity recommendations.
Vitamin E Dosing Study
Nonalcoholic Fatty Liver DiseaseNonalcoholic SteatohepatitisThis is a multicenter, randomized, double masked, placebo-controlled, parallel treatment groups dosing trial of Vitamin E in adult nonalcoholic fatty liver disease (NAFLD).
Semaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Non-Alcoholic...
Type 2 Diabetes MellitusImpaired Glucose Tolerance3 moreThe purpose of this study is to understand the role of GLP-1 in the pathogenesis of T2D in youth and explore their potential salutary effects and ability to delay the progressive loss of ß-cell function and reduce hepatic steatosis in youth with prediabetes/new onset T2D and NAFLD.
Effect of F. Prausnitzii on Glycemic Control
Pre DiabetesImpaired Glucose Tolerance1 moreThe microbiota is associated with a wide spectrum of diseases including diabetes and non-alcoholic fatty liver disease. In this study we will investigate if the bacteria F. prausnitzii, which is a part of the human gut microbiota, can improve metabolic parameters in subjects with impaired glucose control.