Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cascade Pharmaceuticals, Inc
With
Laboratory Corporation of America
This will be a multicenter, double-blind, randomized, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, PKs, and efficacy of CS0159 in the treatment of patients with NASH over 12 weeks.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Patients who meet the diagnosis of NASH.
2. Evidence of metabolic syndrome, except for those patients with biopsy-proven NASH.
3. Body mass index (BMI) \>25 kg/m2, NOTE: for Asian-Americans BMI \>23 kg/m2.
4. Stable use of other antidiabetic, weight loss, or lipid-modifying medications for at least 12 weeks prior to randomization.
You may not be if
1. Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.
2. Previous exposure to farnesoid X receptor (FXR) agonists 3 months prior to the first dosing.
3. Current or within 6 months of screening use of drugs associated with steatosis, including but not limited to eg, methotrexate, amiodarone, high-dose estrogen, tamoxifen, long term systemic steroids, anabolic steroids, valproic acid.
4. Prothrombin time international normalized ratio \>1.3, unless due to therapeutic anticoagulation.
5. Total bilirubin \>upper limit of normal (ULN; except for patients with Gilbert's syndrome with a normal direct bilirubin value and normal reticulocyte count).
Platelet count \<140 000/mm³, absolute neutrophil count \<1500 cells/mm3, or total
6. white blood cells \<3000 cells/mm3.
7. Alanine aminotransferase and aspartate aminotransferase (AST) \>5 × ULN, or alkaline phosphatase (ALP) \>1.5 × ULN.
8. Weight changes \>10% in 6 months prior to screening, or weight changes \>5% from the screening MRI-PDFF to randomization or from the time of the diagnostic liver biopsy to randomization, whichever is longer.
9. Poorly controlled hypertension (systolic \>160 mm Hg, or diastolic blood pressure \>100 mm Hg - mean of 3 measurements).
10. Uncontrolled diabetes mellitus (hemoglobin A1c \>10.0% during screening).
