A Phase 2b study to evaluate the efficacy of different doses of NST-4016 on the resolution of NASH without worsening of fibrosis
This is a 62 week (including screening and follow-up), multicenter, randomized, double blind, placebo-controlled, parallel group study in male and female patients with a histological diagnosis of NASH. The study includes a screening period, double blind treatment period, and post-treatment follow up
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
280
Icosabutate oral capsule once daily
Matching placebo oral capsule
Percentage of Patients With Resolution of NASH, Defined as Disappearance of Ballooning (Score = 0) With Lobular Inflammation Score 0 or 1, With no Worsening of Fibrosis.
Time frame: 52 weeks
Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement and no Worsening of Steatohepatitis (Inflammation/Ballooning).
Time frame: 52 weeks
Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement.
Time frame: 52 weeks
Changes in the Liver Enzymes Aspartate Aminotransferase (AST)U/L, Alanine Aminotransferase ( ALT)U/L and Gamma Glutamyl Transferase (GGT) U/L From Baseline
Time frame: 52 weeks
Change in Bilirubin Micromol/L From Baseline
Time frame: 52 weeks
Change From Baseline in Inflammation Marker hsCRP
Time frame: 52 weeks
Change From Baseline in Fibrosis Activity Marker Pro-C3
Time frame: 52 weeks
Change From Baseline in Fibrosis Activity Marker Enhanced Liver Fibrosis (ELF) Test
ELF is a blood test that measures liver fibrosis by analyzing three markers in the blood: Hyaluronic acid (HA), Procollagen III amino-terminal peptide (PIIINP), and Tissue inhibitor of matrix metalloproteinase 1 (TIMP-1). The higher the score the higher the levels of markers in the blood. ELF score = 2.278 + 0.851 × ln(HA) + 0.751 × ln(PIIINP) + 0.394 × ln(TIMP-1). As the score is a composite measure of the levels of three markers in the blood, there is not a finite range for this parameter.
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Central ResearchAssociates Inc.
Birmingham, Alabama, United States
Arizona Liver Health
Chandler, Arizona, United States
Arizona Liver Health - Glendale
Glendale, Arizona, United States
Arizona Liver Health
Tucson, Arizona, United States
Adobe Clinical Research, LLC
Tucson, Arizona, United States
Arkansas Gastroenterology - North Little Rock
North Little Rock, Arkansas, United States
Fresno Clinical Research Center
Fresno, California, United States
National Research Institute - Huntington Park
Huntington Park, California, United States
National Research Institute - Wilshire
Los Angeles, California, United States
National Research Institute - Panorama
Panorama City, California, United States
...and 29 more locations
Time frame: 52 weeks
Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR is a measure of insulin resistance and metabolic status. The higher the score, the higher the level of insulin resistance. HOMA-IR = fasting glucose \[mmol/L)\] × fasting insulin \[mIU/L\]/22.5. As HOMA-IR is a composite score using 2 parameters, it does not have a finite range.
Time frame: 52 weeks
Change From Baseline in Composite Disease Activity Score (Composite NASH Score of Inflammation, Ballooning, Fibrosis)
The disease activity score can range from 0 to 8 and is calculated by the sum of scores of steatosis (0-3), lobular inflammation (0-3) and hepatocyte ballooning (0-2). The higher the score the more severe the disease.
Time frame: 52 weeks
Change From Baseline in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)
A histological scoring system that assesses a liver biopsy and gives scores for steatosis (0-3), lobular inflammation (0-3), and hepatocyte ballooning (0-2) giving a total score of (0-8). The higher the score the more severe the disease
Time frame: 52 weeks
Changes in Individual Histological Scores for Steatosis, Ballooning, Inflammation, and Fibrosis From Baseline
Changes in scores for the individual component parts of the Nonalcoholic fatty liver disease (NAFLD) activity score (NAS) as judged by a pathologist examining sections from a liver biopsy; steatosis (range 0-3), lobular inflammation (range 0-3), and hepatocyte ballooning (range 0-2) In all cases a higher number denotes more severe disease activity
Time frame: 52 weeks
Change From Baseline in Magnetic Resonance Imaging-Proton Density-Fat Fraction (MRI-PDFF)
MRI-PDFF is a quantitative imaging biomarker that measures the fat fraction of tissue by correcting factors influencing magnetic resonance signal intensity.
Time frame: 52 weeks