Clinical trial NCT05591079: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CS0159 in Subjects With NASH
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of CS0159 in the Treatment of Patients With Nonalcoholic Steatohepatitis (NASH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nonalcoholic Steatohepatitis (NASH)
Lead sponsor: Cascade Pharmaceuticals, Inc
Sponsor class: OTHER
Collaborators: name: Laboratory Corporation of America
First posted: 2022-10-24
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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).

Primary outcomes:
measure: MRI-PDFF
timeFrame: Week 12
measure: Adverse events
timeFrame: Week 12
Secondary outcomes:
measure: Cmax
timeFrame: week 6, week 12
measure: tmax
timeFrame: week 6, week 12
measure: t1/2
timeFrame: week 6, week 12
measure: AUC
timeFrame: week 6, week 12
measure: Pharmacodynamics (PD)
timeFrame: week 6, week 12
Other outcomes:
Locations:
city: Gardena
country: United States
facility: National Research Institute - Gardena
state: California
city: Huntington Park
country: United States
facility: Velocity Clinical Research, Huntington Park
state: California
city: Panorama City
country: United States
facility: Velocity Clinical Research - Panorama City
state: California
city: Santa Ana
country: United States
facility: Velocity Clinical Research - Santa Ana
state: California
city: Lady Lake
country: United States
facility: Ocala GI Research
state: Florida
city: Lakewood
country: United States
facility: Florida Research Institute
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Clinical Research, LLC - Miami Lakes
state: Florida
city: Miami
country: United States
facility: San Marcus Research Clinic, Inc - Miami
state: Florida
city: Ocala
country: United States
facility: Gastroenterology Associates of Ocala
state: Florida
city: College Park
country: United States
facility: Oracle Clinical Research
state: Georgia
city: Marrero
country: United States
facility: Metropolitan Gastroenterology Associates - Westbank Office and Endoscopy
state: Louisiana
city: Greenbelt
country: United States
facility: Raja M. Din MD, PLLC - Gastroenterology & Hepatology
state: Maryland
city: Morehead City
country: United States
facility: Lucas Research
state: North Carolina
city: Austin
country: United States
facility: Texas Liver Institute (TLI) - Austin
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions Inc - Houston - Stancliff Rd
state: Texas
city: San Antonio
country: United States
facility: The Texas Liver Institute, Inc.
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC
state: Texas
Study officials:
affiliation: Cascade Pharmaceuticals, Inc
name: Rong Deng
role: STUDY_DIRECTOR
References: