Fatty Liver Disease (NAFLD/MASLD)

Researchers are studying chronic liver diseases and tumors, including non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD), cirrhosis, and hepatocellular carcinoma (HCC). These conditions can be caused by viral infections like hepatitis B, C, and D or lifestyle factors such as overeating and lack of exercise. The goal is to develop better understanding and new treatments by analyzing liver tissues and tumors at the single-cell level to identify therapeutic targets and improve patient outcomes. The study involves creating patient-derived preclinical models, such as spheroid cultures and mouse xenograft models, to test new treatment strategies. Blood samples and tissue biopsies are collected during surgeries, biopsies, or diagnostic tests. Researchers use advanced molecular techniques like single-cell RNA sequencing to examine tumor heterogeneity and the liver environment, aiming to discover new biomarkers and treatment predictors. Participants will undergo procedures as part of their care, including hepato-bilio-pancreatic surgery, biopsies, or locoregional treatments. Blood samples are taken during these procedures to support research. Researchers will monitor surgery outcomes over an average of eight years. By studying patient samples and clinical data, the team aims to improve personalized medicine approaches and identify new preventive and therapeutic targets for chronic liver diseases and liver cancer.

Researchers are investigating whether a multifactorial lifestyle intervention involving a Mediterranean diet with reduced calories and increased physical activity can help middle-aged adults (30-50 years) with metabolic syndrome lose weight and maintain that weight loss over time. The study also aims to understand the social and demographic challenges people face in sticking to these healthy habits and to examine the lifestyle patterns of this group. Participants will be randomly assigned to one of two groups. One group will follow general lifestyle recommendations from primary healthcare providers, while the other will receive an intensive program that includes monthly individual and group sessions over 6 months to encourage a Mediterranean diet with 25% fewer calories and physical activity based on WHO guidelines. The goal for the intervention group is to reduce their initial weight by 5-10% within 6 months and maintain this loss after 12 months. Throughout the study, participants will undergo assessments including measurements of weight, waist size, blood sugar, triglycerides, and glycated hemoglobin to monitor changes in their health. Data on demographics, diet, clinical parameters, and laboratory tests will be collected. After the 6-month intervention, a follow-up at 12 months will evaluate how well participants maintain their lifestyle changes. The study emphasizes tracking adherence and identifying factors that help or hinder long-term weight loss maintenance.

Noncommunicable diseases like type 2 diabetes and cardiovascular disease cause more deaths worldwide than any other conditions, with a growing impact especially in low- and middle-income countries. Cardiovascular disease (CVD) is a leading cause of death globally, and its prevalence is rising despite awareness efforts. Diet and nutrition are important factors influencing these diseases, and this research explores the role of a traditional Chinese medicine nutritional drink in supporting cardiovascular health. The study evaluates the effects of the "Perfect Heartio" drink, a nutritional supplement made from diluted herbal extracts traditionally used in Chinese medicine. Participants will consume 15 grams of the drink twice daily for 12 weeks while their compliance is monitored. This intervention is being studied to assess its potential in improving heart and blood vessel function by measuring various cardiovascular health indicators. Participants will be assessed at the start and at weeks 4, 8, and 12 for lipid profiles, heart inflammation, heart injury, and heart remodeling. Quality of life and self-perceived health status will also be evaluated over these timepoints. The study includes healthy adults aged 18 and above who agree to follow the intervention plan and attend follow-up visits. Monitoring throughout the study will help researchers understand the drink's impact on cardiovascular health markers over the 12-week period.

Researchers are evaluating whether taking tirzepatide before bariatric surgery can improve health outcomes for people with obesity and related medical conditions. This study aims to see if tirzepatide reduces inflammation in tissues and blood before surgery and how these changes relate to weight loss, metabolic improvements, and fewer complications after surgery. The trial is a Phase 4 interventional study comparing patients who take tirzepatide with those who do not before their planned surgery. Participants who are assigned to the tirzepatide group will self-inject 2.5 mg of tirzepatide once weekly for three months before surgery, following dose escalation instructions if needed. Both groups will receive education on dietary and lifestyle changes. During the three months before surgery, participants will visit the endocrine clinic monthly for drug prescription and side effect monitoring. The study continues through the surgery and post-surgery follow-up periods. Throughout the study, participants will keep a diary of drug use and side effects, and researchers will measure inflammatory markers such as C-reactive protein, interleukin 6, tumor necrosis factor, leptin, adiponectin, and RAAS at baseline, three months after drug use, and several times after surgery. Weight, blood pressure, blood sugar, cholesterol, and surgical complications will also be tracked up to one year after surgery. Participant involvement includes regular clinic visits, lab tests, and monitoring to assess the impact of tirzepatide on surgical outcomes and inflammation.

Researchers are evaluating the effectiveness of a six-month virtually-delivered dietary education program called PEDALL to prevent overweight and obesity during maintenance chemotherapy in children and adolescents with acute lymphoblastic leukemia (ALL). The study focuses on English and Spanish speaking families and considers key genetic and sociodemographic risk factors that may affect weight gain during treatment. Participants will be randomly assigned to one of two groups: the PEDALL intervention group or the standard of care (SOC) group. The PEDALL group will receive 26 contact hours of specialized nutrition education through weekly one-hour virtual sessions over six months. The SOC group will receive printed educational materials and nutritional care according to their institution's usual practices. During the study, participants and their caregivers will engage in nutrition education and counseling sessions. Researchers will assess weight status, body mass index trajectories, lifestyle behaviors, and the influence of genetic and sociodemographic factors over time. The main goal is to prevent unhealthy weight gain during maintenance chemotherapy and improve long-term health outcomes for childhood ALL survivors. The study will last up to 3.5 years for primary outcomes, with additional follow-up extending to four years.

Researchers are investigating the relationship between obesity and type 2 diabetes, conditions influenced by both genetic and environmental factors. This study aims to better understand how different genetic variations affect gene expression in tissues involved in glucose and lipid metabolism, which may contribute to what is called "diabesity," a combined condition of diabetes and obesity. The study uses advanced genomic techniques and bioinformatics to analyze these factors in both humans and animal models. Participants in this observational study are grouped based on their body mass index (BMI) and diabetes or glucose intolerance status. Groups include individuals with BMI ≥ 35 kg/m2 with diabetes, glucose intolerance, or without diabetes, as well as those with BMI < 27 kg/m2 and BMI between 27 and 35 kg/m2 without diabetes. Samples are collected during abdominal surgeries such as bariatric surgery or cholecystectomy to study gene expression and metabolic pathways. During the study, researchers collect biological samples at baseline and follow participants over several years to assess changes in gene expression and insulin resistance. They also evaluate clinical and biological features before and after bariatric surgery at 1, 2, and 5 years. The primary measurement focuses on gene expression in tissues related to glucose metabolism. This long-term observation helps to understand the genetic and phenotypic factors influencing obesity and diabetes, with participation lasting up to 5 years.

Researchers are evaluating the safety, tolerability, and how the body processes Semaglutide Nasal Spray compared to a placebo and a known injection in adults who are overweight or obese. This Phase I clinical trial aims to better understand the effects of the nasal spray formulation of Semaglutide in this population. The study is sponsored by Shanghai World Leader Pharmaceutical Co., Ltd. and focuses on adults aged 18 to 65 years with specific body mass index ranges. Participants will receive either the Semaglutide Nasal Spray, placebo, or a Semaglutide injection (Wegovy®) in different randomized groups. The study involves a single-dose administration and includes several cohorts receiving various combinations of the nasal spray and placebo or the injection. Treatments are given once, and the study monitors the participants for up to 36 days after administration to assess drug levels and effects. During the study, participants will undergo various evaluations including blood tests, vital signs monitoring, physical examinations, electrocardiograms (ECGs), and urine analyses from Day 1 to Day 36. Researchers will measure how much of the drug reaches the blood, how long it stays, and any side effects that occur. Antibody levels against the drug will also be checked up to Day 29. Participants will be closely monitored for any safety concerns throughout the study period.

Researchers are evaluating enicepatide, a drug that acts on two receptors related to blood sugar and weight control, for its effects on weight management in people with obesity or overweight who also have Type 2 diabetes mellitus (T2DM). This Phase III study compares multiple doses of enicepatide to a placebo to assess both effectiveness and safety over a long period. Participants will be randomly assigned to one of four groups: three different dosing regimens of enicepatide or a placebo. Both enicepatide and placebo are given once weekly using an integrated drug-device combination product. The study uses a double-blind design, so neither participants nor researchers know who receives the active drug or placebo. Treatment lasts for 72 weeks, allowing detailed assessment of changes over time. Throughout the study, participants will regularly have their body weight measured to track percentage change from baseline, along with many other health indicators including blood sugar levels, cholesterol, blood pressure, and quality of life surveys. Safety will also be closely monitored through assessments of adverse events and specific health questionnaires. The total participation period extends through 72 weeks of treatment and follow-up to observe long-term effects.

Researchers are evaluating the effects of enicepatide, a dual GLP-1/GIP receptor agonist, for weight management in adults with obesity or overweight who do not have Type 2 diabetes. This Phase III trial aims to assess the safety and effectiveness of multiple doses of enicepatide compared with placebo, focusing on body weight changes and related health outcomes. The study is sponsored by Hoffmann-La Roche and targets participants with specific body mass index criteria and weight-related health conditions. Participants will be randomly assigned to one of four groups: three different dosing regimens of enicepatide or a placebo. Both enicepatide and placebo are given once weekly using an integrated drug-device combination product. The treatment period lasts 72 weeks, during which the participants receive regular doses as per their assigned group. Throughout the study, participants will be monitored for changes in body weight, waist circumference, blood sugar levels, cholesterol, blood pressure, and quality of life measures. Assessments include physical exams, questionnaires, and imaging such as MRI to measure body composition. Safety is closely tracked through adverse event reporting and mental health assessments. The total participation duration extends through the 72-week treatment and evaluation period, with detailed follow-up on various health indicators.

Researchers are evaluating the safety and tolerability of Efimosfermin Alfa in adults aged 18 to 75 years who have known or suspected metabolic dysfunction-associated steatohepatitis (MASH) with liver fibrosis at stages F2 or F3. This phase 3, randomized, double-blind, placebo-controlled study aims to better understand how this drug affects participants with this liver condition related to metabolic syndrome components. Participants will be randomly assigned to one of three groups: one receiving Efimosfermin Alfa at dose level 1, another receiving Efimosfermin Alfa at dose level 2, and a third group receiving a placebo. The study will monitor the effects of these treatments over a period of 52 weeks, assessing safety and tolerability as well as changes in liver fibrosis markers and other related health measures. During the trial, participants will undergo regular assessments including laboratory tests, imaging scans such as MRI and elastography to measure liver stiffness and fat content, and blood tests to monitor liver enzymes and metabolic markers. Researchers will track treatment-emergent adverse events and laboratory abnormalities. The study involves continuous monitoring up to week 52 to evaluate changes from baseline and to ensure participant safety throughout the trial.