The primary objective of this study is to assess the efficacy of rifaximin SSD-40IR versus placebo to delay the occurrence of HE-related hospitalization/emergency department visit/initiation of HE therapies.
The study is designed to evaluate the effects of the combination of zibotentan and
dapagliflozin and dapagliflozin monotherapy versus placebo on the hepatic venous pressure gradient (HVPG) response in participants with cirrhosis with features of portal hypertension at 6 weeks of treatment.
Part A is to evaluate the absolute
change in HVPG at 6 weeks from baseline in participants treated with 2.5 mg zibotentan combined with 10 mg dapagliflozin versus placebo. The primary efficacy objective for Part B is to evaluate the proportion of participants treated with 1, 2.5, or 5 mg zibotentan combined with 10 mg dapagliflozin and 10 mg dapagliflozin monotherapy versus placebo achieving a ≥ 20% decrease in HVPG or a reduction to or below 12 mmHg in HVPG
This study will evaluate male and female subjects between 18 and 70 years of age, diagnosed with decompensated cirrhosis with ascites that have developed HRS-AKI, as defined by International Club of Ascites (ICA) criteria; minimum entry serum
creatinine ≥1.5 mg/dL.
In this Phase II trial the efficacy of treatment in patients with clinically significant portal hypertension (CSPH), in compensated alcohol-related cirrhosis, will be assessed. This will be the first trial in the clinical development of the drug BI 685509 where patients will be treated for 24 weeks, and where the portal pressure will be assessed quantitatively via HVPG measurements. The trial will evaluate both short-term and long-term efficacy. The long-term assessment will be used to rule out any adaptation to sGC activation on portal pressure on chronic treatment. The trial will also provide supportive evidence for the planned Phase III development.
This is a Phase 2, randomized, double-blind, double-dummy,
placebo-controlled study evaluating the efficacy and safety of SEMA,
CILO/FIR, and their combination in subjects with compensated
cirrhosis due to NASH.
Collection of Blood to Evaluate Epigenomics and Protein Biomarkers for the Detection of Hepatocellular Carcinoma
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage 2 or 3 and consists of 2 parts - Part 1 and Part 2.
There is a new investigational drug called DUR-928. This study is being done to see if this investigational drug helps in the treatment of Alcoholic Hepatitis (AH).
The hope is that the use of DUR-928 will lead to lowering the MELD (Model for end-stage liver disease) score, some other liver blood tests, and then other symptoms of AH may get better.
The purpose of this study is to find out about the safety and effectiveness of an investigation drug called Semaglutide for the treatment of NASH. (Non-Alcoholic Steatohepatitis). NASH occurs when the fat buildup in the liver leads to inflammation (hepatitis) and scarring. NASH is associated with increased risk of morbidity (medical problem or complication) and mortality (death). Currently, treatment options are few and insufficient. There is therefore an unmet medical need for effective and safe pharmacological treatment options. The study is designed to last 257 weeks (approximately 4 years and 11 months), with study visits occurring approximately every 4 weeks. Most visits will include blood work and some will include assessments such as body weight and vital signs. Most visits will include reviewing of diary entries during the course of the study. This study also includes weekly injections of semaglutide (or placebo). Semaglutide is a self-administered injection that is given under the skin. Semaglutide has built an extensive amount of data with other trials that have focused on weight management and Type 2 diabetes. Semaglutide is FDA-approved for diabetes treatment, but is investigational for this study. In these previous trials, semaglutide was found to be safe and well-tolerated. This study is randomized, double-blinded, and placebo-controlled. This means that you may receive the study drug or a placebo. Neither the study subject or the study team members will know which each subject will be receiving. Study subjects will be randomized 2:1. This means that subjects will have a greater chance (66%) of receiving the drug versus the placebo.