Clinical Research Directory

A Study of CS060380 Tablets in Patients With MASH and Obesity

this study is looking at a new investigational medicine called CS060380, when used together with semaglutide, in adults who have both metabolic dysfunction-associated steatohepatitis (MASH) and obesity. MASH is a condition where too much fat builds up in the liver, leading to inflammation and damage. Obesity is a major risk factor for this condition. This is a Phase II clinical trial, which means we are testing the medicine to see if it works and is safe. The study will last up to 54 weeks, which is a little over a year. It includes: * A screening period of up to 2 weeks to check if you are eligible to take part. * A 36-week double-blind treatment period, where you will be randomly assigned (like flipping a coin) to receive either the study drug CS060380 or a placebo (an inactive pill that looks like the study drug). Both groups will also receive semaglutide, which is an approved medicine for weight management. Neither you nor your doctor will know which treatment you are receiving. * A 16-week open-label period, where all participants will receive CS060380. The main goal of this study is to see how the study drug affects the amount of fat in the liver, measured by a special MRI scan, and body weight. We will also monitor your overall health and safety throughout the study by checking your vital signs, doing blood and urine tests, and asking about any side effects you might experience. About 120 participants will take part in this study at almost 15 different hospitals across China, with Ruijin Hospital in Shanghai as the main study site.

A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Adult Participants at Increased Genetic Risk for This Condition

This study is researching an investigational drug, ALN-HSD called "study drug". This study is focused on participants who are known to have metabolic dysfunction-associated steatohepatitis (MASH). MASH is a form of metabolic dysfunction-associated steatotic liver disease (MASLD). MASH occurs when fat builds up in liver cells, damaging them, and making the liver inflamed and stiff from fibrosis (scar tissue). MASH can progress to cirrhosis (long term scarring) and liver failure (when the liver cannot perform its job). The aim of the study is to see the effect of the study drug on lessening liver scarring side effects related to MASH. The study is looking at several other research questions, including: * How ALN-HSD works to improve liver function and lessen MASH-related inflammation in the liver * What side effects may happen from receiving the study drug * How much study drug and study drug metabolites (byproduct of the body breaking down the study drug) are in the blood at different times * Better understanding of the study drug and MASH

A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Miricorilant in Adult Patients with Nonalcoholic Steatohepatitis (MONARCH)

A Study of UBT251 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)

This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating the efficacy and safety of UBT251 in MASH subjects. Subjects will be randomly assigned to UBT251 2mg-dose, 4mg-dose，6mg-dose and placebo groups. The entire trial cycle includes a 6-week screening period, a 48-week double-blind treatment period, and a 4-week follow-up period.

A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)

This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating the efficacy and safety of IBI362 in MASH subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. The entire trial cycle includes a 8-week screening period, a 60-week double-blind treatment period, and a 4-week follow-up period.

Clinical Classification of MAFLD Based Liver Biopsy

Metabolic dysfunction-associated Fatty Liver Disease (MAFLD), also known as Non-Alcoholic Fatty Liver Disease (NAFLD), is the most common chronic progressive liver disease in China. It is closely related to the high incidence of cardiovascular-renal-metabolic syndrome and both liver and non-liver malignancies, posing a serious threat to public health. However, the diagnostic criteria for MAFLD are not unified globally, and the classification and staging still rely on liver biopsy for pathological assessment. The characteristics, mechanisms, and predictive indicators of liver and extrahepatic disease outcomes in MAFLD patients are not yet clear. The severe form of MAFLD, metabolic dysfunction-associated steatohepatitis (MASH), has been a hot and challenging area of research for non-invasive tests (NITs). However, serum markers, imaging examinations, and novel markers under development cannot replace liver biopsy for the diagnosis of MASH. Clinically, the disease outcomes of MAFLD mainly depend on metabolic cardiovascular risk factors and fibrosis staging. Both liver biopsy and NIT-diagnosed advanced fibrosis and cirrhosis can predict liver-related events and all-cause mortality risks in MAFLD patients. Artificial intelligence and machine learning methods can improve the consistency of pathologists in diagnosing MASH and fibrosis. The Agile score, which combines gender, T2DM status, AST/ALT ratio, platelet count, and liver stiffness measurement (LSM), can improve the diagnostic efficacy of advanced fibrosis and cirrhosis in MAFLD patients and the efficiency of predicting liver-related events. However, the predictive effect of fibrosis staging and its changes on liver cancer needs to be improved. There is a lack of high-quality research on early warning indicators for the incidence of CVD, chronic kidney disease, and non-liver malignancies in MAFLD patients. It is necessary to explore the role of conventional indicators such as low-density lipoprotein cholesterol, lipoprotein(a), uric acid, and high-sensitivity C-reactive protein, as well as multi-omics parameters, in the classification, staging, and risk prediction of MAFLD. MAFLD is an increasingly serious public health issue associated with a higher risk of liver-related events, cardiovascular-renal-metabolic syndrome, and malignancies. The prevalence of MAFLD in China is high, but the rate of standardized management is low. Even patients with the same classification and staging often have different clinical characteristics and outcomes. There is currently a lack of a clinical classification and early warning system for MAFLD that combines metabolic cardiovascular risk factors and NITs for different outcome risks.