A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CS0159 in Subjects With NASH

Completed · Phase 2 · Has a placebo group

Conditions studied: Nonalcoholic Steatohepatitis (NASH)

In brief

A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of CS0159 in subjects with Non-Alcoholic Steatohepatitis (NASH)

Key facts

Study ID

NCT05591079

Run by

Cascade Pharmaceuticals, Inc

People needed

99

Starts

2023-02-10

Expected to finish

2023-11-09

Last updated by the study team

2023-11-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who meet the diagnosis of NASH.
• Evidence of metabolic syndrome, except for those patients with biopsy-proven NASH.
• Body mass index (BMI) >25 kg/m2, NOTE: for Asian-Americans BMI >23 kg/m2.
• Stable use of other antidiabetic, weight loss, or lipid-modifying medications for at least 12 weeks prior to randomization.

You may not qualify if…

• Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.
• Previous exposure to farnesoid X receptor (FXR) agonists 3 months prior to the first dosing.
• 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.
• Prothrombin time international normalized ratio >1.3, unless due to therapeutic anticoagulation.
• 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
• white blood cells <3000 cells/mm3.
• Alanine aminotransferase and aspartate aminotransferase (AST) >5 × ULN, or alkaline phosphatase (ALP) >1.5 × ULN.
• 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.
• Poorly controlled hypertension (systolic >160 mm Hg, or diastolic blood pressure >100 mm Hg - mean of 3 measurements).
• Uncontrolled diabetes mellitus (hemoglobin A1c >10.0% during screening).

Where it is running

• National Research Institute - Gardena — Gardena, California, United States
• Velocity Clinical Research, Huntington Park — Huntington Park, California, United States
• Velocity Clinical Research - Panorama City — Panorama City, California, United States
• Velocity Clinical Research - Santa Ana — Santa Ana, California, United States
• Ocala GI Research — Lady Lake, Florida, United States
• Florida Research Institute — Lakewood, Florida, United States
• San Marcus Research Clinic, Inc - Miami — Miami, Florida, United States
• Floridian Clinical Research, LLC - Miami Lakes — Miami Lakes, Florida, United States
• Gastroenterology Associates of Ocala — Ocala, Florida, United States
• Oracle Clinical Research — College Park, Georgia, United States
• Metropolitan Gastroenterology Associates - Westbank Office and Endoscopy — Marrero, Louisiana, United States
• Raja M. Din MD, PLLC - Gastroenterology & Hepatology — Greenbelt, Maryland, United States
• Lucas Research — Morehead City, North Carolina, United States
• Texas Liver Institute (TLI) - Austin — Austin, Texas, United States
• Pioneer Research Solutions Inc - Houston - Stancliff Rd — Houston, Texas, United States
• The Texas Liver Institute, Inc. — San Antonio, Texas, United States
• Clinical Trials of Texas, LLC — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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