Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide...
Non-Alcoholic SteatohepatitisNon-Alcoholic Fatty Liver DiseaseBackground: In non-alcoholic fatty liver disease (NAFLD), fat accumulates in the liver and can cause damage. Researchers want to learn what causes the damage NAFLD, and to see if a medication can help. Objective: To find out how the liver in people with NAFLD responds to feeding, and how this relates to their response to the drug semaglutide. Eligibility: People with NAFLD and healthy volunteers ages 18 and older Design: Participants will be screened with: Medical history Physical exam Blood tests Imaging: A machine will take pictures of the participant s body. Within 2-8 weeks of enrollment, participants will stay in the clinic for several days. This includes: Blood, urine, heart, and imaging tests For NAFLD participants only: A needle-like device will remove a small biopsy of the liver and fatty tissue. Participants will be alone in a special room for 5 hours. They will breathe through a tube under the nostrils. They will have blood drawn several times. The baseline visit concludes participation for healthy volunteers but NAFLD participants will contine. About 6 weeks after discharge, participants will stay in the clinic again and repeat the tests. They will get their first semaglutide dose by injection. Participants will have visits weeks 1, 2, 4, 8, 12, 16, 20, and 24 of treatment. Visits include blood tests. Participants will inject semaglutide once a week at home. At week 30, participants will stay in the clinic again and repeat the tests. Participants will have a final visit 12 weeks after stopping treatment. This includes blood and urine tests. ...
Safety, Tolerability, and Bioeffects of Alirocumab in Non-treatment Seeking Heavy Drinkers
Alcohol Associated Liver DiseaseHeavy Drinking BehaviorBackground: Drinking alcohol can lead to swelling and injury in the liver. Long-term heavy drinking may lead to liver disease. Researchers want to study the relationship between a drug called alirocumab, alcohol use, and liver functioning/swelling. Objective: To study the effects of alirocumab in people who drink alcohol. Eligibility: Healthy adults ages 21 to 65 who regularly consume 20 or more drinks per week. Design: Participants will be screened under protocol 14-AA-0181. Participants will get alirocumab or a placebo as an injection under the skin. Participants will give blood and urine samples. They will have physical exams. Participants will have FibroScans . It measures liver and spleen stiffness. Participants will lie on a table. They will expose the lower right and left side of their chest. The machine will send a small vibration to the liver. Participants may have magnetic resonance imaging (MRI) scans of the liver. The MRI scanner is shaped like a cylinder. Participants will lie on a table that slides in and out of the scanner. A device called a coil will be placed over their liver. Participants will have a Doppler scan and ultrasound. These tests measure blood flow in the body. Participants will have an electrocardiogram. It measures heart function. Participants will fill out surveys about how they are feeling, their alcohol consumption, and other behaviors. They will complete cognitive tasks on a computer. Participants will meet with a clinician. They will discuss the participant s assessment results, patterns of drinking, and possibly stopping or cutting down on drinking. Participation will last for 8 weeks. Participants will have 9 study visits.
A Study to Learn About the Study Medicine (Called Lorlatinib) in People With Liver Dysfunction
Moderate Hepatic ImpairmentSevere Hepatic Impairment1 moreThe purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Lorlatinib) in health participants. This study is seeking participants who: Must be male or female of non-child bearing potential of 18 to 75 years of age, inclusive at the time of the study. Are willing and able to comply with all scheduled visits, treatment plan, and other study procedures. Have a BMI (body mass index) of 17.5 to 40 kg/m2; and a total body weight >50 kg (110 lb). Are capable of giving signed informed consent document. All participants in this study will receive Lorlatinib. Participants will be placed into 1 of 3 cohorts based on their hepatic (liver) function. Participants will take Lorlatinib once by mouth. We will examine the experiences of people receiving the study medicine. This will help us determine if the study medicine is safe and effective. Participants will take part in this study for up to 35 days.
A Study to Compare How the Study Medicine (PF-07923568) is Processed in Participants With Different...
Liver DiseasesHepatic ImpairmentThe purpose of this study is to learn how the study medicine (PF-07923568) is processed in participants with liver function loss compared to healthy participants. The different levels of liver function loss can be mild, moderate or severe. This study is seeking participants who: are male or female of 18 years of age or older. are examined to be healthy (group with no loss of liver function). have mild, moderate, and severe liver disease (group with loss of liver function). All participants will receive a one-time dose of 4 capsules of PF-07923568 which will be taken by mouth. All participants will remain at the study clinic for 6 days for safety review and laboratory collections. This is to see how the study medicine is being broken down by the liver over time. All participants selected in the study will be required to go through a screening period up to 28 days. A screening period is the time during which a few participants are examined to see whether they are fit for the study. During this period, the participant's medical history and past and current medications will be reviewed. A series of tests will also be performed to see if they are good to be selected for the study. If the participant meets all required criteria and are interested in continuing, the participant will be brought into the study clinic to stay overnight for 6 days. On day 6, the participant will be discharged. About 28 to 35 days after discharge, the participant will be contacted for a follow up visit either in person or by telephone. This is to check up on how the participant is doing and to conclude the study.
Effects of Bacillus Coagulans on Liver and Gut Microbiota Function in NAFLD
Effects of Bacillus Coagulans TCI711 Supplementation on Liver and Gut Microbiota Function in Non-alcoholic Fatty Liver Disease PatientsAccording to the 2018 statistics of the American Association of Liver Diseases, about 25% of the world's population has non-alcoholic fatty liver disease, and about 10 to 20% of patients with simple fatty liver will develop non-alcoholic steatohepatitis, and about 25 to 50% of non-alcoholic fatty liver patients will continue to develop liver fibrosis, which may even lead to liver cirrhosis or liver cancer, so how to improve the liver fat accumulation of non-alcoholic fatty liver patients is one of the topics that scholars in related fields have paid attention to in recent years . Bacillus coagulans is a Gram-positive bacterium belonging to the genus Bacillus and does not exist in the intestinal microbiota, because it has the characteristics of spore production and lactobacillus lactic acid production, and has the ability to maintain the health of intestinal bacteria, acid and alkali resistance, With the advantages of high temperature resistance and high stability, it is currently one of the commonly used probiotic strains. Clinical studies have shown that after intervention of a single Bacillus coagulans strain in patients with non-alcoholic fatty liver disease, the problem of liver fat accumulation and inflammation can be significantly improved, so supplementing Bacillus coagulans TCI711 probiotics isolated from apples may improve Functions of liver and gut microbiota in patients with nonalcoholic fatty liver disease. Therefore, this experiment is to investigate the effect of supplementing Bacillus coagulans TCI711 probiotics on the function of liver and intestinal flora in fatty liver patients.
A Study of TAK-279 in Adults With or Without Liver Damage
Hepatic ImpairmentHealthy VolunteersThe main aim of this study is to find out how the body processes 1 dose of TAK-279 (pharmacokinetics) in participants with liver problems compared to participants without liver problems. Other aims are to check for side effects from TAK-279 and to learn how well participants tolerate 1 dose of TAK-279. The participants will need to stay at the clinic for 11 days.
A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Nonalcoholic Fatty...
Non-Alcoholic Fatty Liver DiseaseThe main purpose of this study is to evaluate the safety and tolerability of the study drug LY3849891 in participants with nonalcoholic fatty liver disease who have the patatin-like phospholipase domain-containing protein 3 (PNPLA3) I148M genotype. Blood tests and magnetic resonance imaging of the liver will be performed to determine the effects of LY3849891 on fatty liver disease. Blood tests will also determine how long it takes the body to eliminate LY3849891. This is a 2-part study and may last up to 32 weeks for each participant and may include 12 and 13 visits in parts A and B, respectively.
Prebiotics in Patients With Non-alcoholic Liver Disease
Non-alcoholic Fatty Liver DiseaseMetabolic SyndromeThe purpose of this present study is to evaluating whether prebiotics - ITF (Inulin/OFS 75/25) is effective in treating patients with non-alcoholic liver disease.
CT Liver Fat Fraction Quantification
Non-Alcoholic Fatty Liver DiseaseSteatosis of LiverOur aim is to develop an AI based tool to use ultra-low dose CT in two separate energy levels using a single-energy CT machine to quantify liver fat in individuals at risk for having non-alcoholic fatty liver disease (NAFLD), compared to MRI which serves as the standard of reference. Secondary aim of our study is to validate the developed artificial intelligence (AI)-based model on a second group of participants ("external validation").
A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic...
Progressive Familial Intrahepatic CholestasisAlagille Syndrome1 moreThis study is designed to assess whether the investigational drug maralixibat, is safe and well tolerated in children <12 months of age with Alagille Syndrome [ALGS] or Progressive Familial Intrahepatic Cholestasis [PFIC].