CS0159 for NASH
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called CS0159 (Linafexor) to evaluate its safety and effectiveness for individuals with Non-Alcoholic Steatohepatitis (NASH), a liver disease linked to fat buildup. Participants will receive one of two doses of CS0159 or a placebo (a non-active pill) for 12 weeks. Suitable candidates have been diagnosed with NASH and meet specific health criteria, such as a body mass index (BMI) over 25 (or over 23 for Asian-Americans) and stable use of medications for diabetes, weight loss, or cholesterol. The study aims to determine if CS0159 can improve liver health in those with NASH. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires that you have been on stable doses of antidiabetic, weight loss, or lipid-modifying medications for at least 12 weeks before joining. However, you cannot use certain other drugs, like those associated with liver issues, within specific time frames before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Linafexor (CS0159) is generally safe and well-tolerated. In earlier studies, participants reported no negative side effects, indicating the treatment's safety. Linafexor has also been tested in individuals with various liver conditions, such as Primary Biliary Cholangitis (PBC), and demonstrated promising safety results. Although this treatment remains under study, the current information reassures those considering participation in a clinical trial for Non-Alcoholic Steatohepatitis (NASH).12345
Why do researchers think this study treatment might be promising for NASH?
Researchers are excited about CS0159 (Linafexor) for treating NASH because it offers a novel approach to tackling this condition. Unlike current treatments that primarily focus on lifestyle changes and controlling related conditions like diabetes and high cholesterol, Linafexor targets the FXR (farnesoid X receptor) pathway, which plays a key role in regulating liver fat and inflammation. This unique mechanism of action could potentially lead to more effective management of NASH by directly addressing the liver's metabolic processes. Additionally, the oral tablet form of Linafexor, taken once daily, makes it convenient for patients to adhere to their treatment regimen.
What evidence suggests that CS0159 might be an effective treatment for NASH?
Research shows that CS0159, also known as Linafexor, could help treat Non-Alcoholic Steatohepatitis (NASH). Earlier studies have found significant improvements in key signs of NASH, suggesting its potential effectiveness. CS0159 has already proven effective and safe for individuals with Primary Biliary Cholangitis (PBC), another liver disease, which increases confidence in its potential for NASH. Early research suggests it might help reduce liver inflammation and fat buildup, major issues in NASH. Based on these findings, CS0159 holds promise as a treatment for NASH. Participants in this trial will receive either 2mg or 1.4mg of CS0159, or a placebo, to further evaluate its effectiveness and safety for NASH.13567
Who Is on the Research Team?
Rong Deng
Principal Investigator
Cascade Pharmaceuticals, Inc
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either 2mg or 1.4mg of CS0159 or placebo daily for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CS0159 (Linafexor)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cascade Pharmaceuticals, Inc
Lead Sponsor
Laboratory Corporation of America
Industry Sponsor