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2mg CS0159 for Non-alcoholic Fatty Liver Disease
Study Summary
This trial tests a new drug to treat NASH, a liver disease, to see if it's safe and effective.
- Non-alcoholic Fatty Liver Disease
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have taken medications that activate the farnesoid X receptor (FXR) within the past 3 months.You have been diagnosed with a condition called NASH.You have metabolic syndrome, except if you have been diagnosed with NASH through a liver biopsy.
- Group 1: 2mg CS0159
- Group 2: 1.4mg CS0159
- Group 3: PLACEBO
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are individuals aged 30 and above being taken into consideration for this research trial?
"The minimum age requirement for this clinical trial is 18 years old, and the maximum age limit is 75."
Is the participant recruitment phase of this trial still ongoing?
"According to clinicaltrials.gov, this medical trial is currently open and actively recruiting patients; the study was initially published on February 10th 2023 with edits made as recently as February 18th of the same year."
How many volunteers have enrolled in this experiment?
"Affirmative, the trial is actively looking for participants. The study was initially posted on February 10th 2023 and recently updated on 18th of the same month. Currently, they are searching to recruit 100 patients from 1 site."
How hazardous would be the effects of ingesting 1.4mg CS0159?
"Our assessment of 1.4mg CS0159 was a 2 on our scale from 1 to 3, as this is in its Phase 2 trial and has some evidence for safety but not yet efficacy."
What are the core objectives of this research initiative?
"Laboratory Corporation of America, the study sponsor, has reported that over a 12-week period they will be primarily measuring Adverse events. Additionally they will be assessing secondary metrics such as tmax (maximum plasma concentration time span), t1/2 (half-life of drug) and AUC (accumulation ratio)."
Does my profile meet the criteria for this trial's enrollment?
"This medical trial is looking for approximately 100 participants aged between 18 and 75 who have been diagnosed with non-alcoholic fatty liver disease (NAFLD). Furthermore, they must meet the following criteria: display symptoms of NASH., possess evidence of metabolic syndrome, unless their condition has already been confirmed by biopsy results; BMI >25 kg/m2 or higher (or alternatively 23kg/m2 if they are an Asian American); and steady use of antidiabetic medication, weight reduction treatments, or lipid modifiers over a 12 week period prior to randomization."
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