Emricasan, a Caspase Inhibitor, for Evaluation in Subjects With Non-Alcoholic Steatohepatitis (NASH) Fibrosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-alcoholic Steatohepatitis, Fibrosis, Liver Diseases

In brief

This is a multicenter, double-blind, randomized, placebo-controlled trial involving subjects with a diagnosis of "definite NASH" with fibrosis (excluding cirrhosis) as determined by the central histopathologist. Upon successful screening, subjects will be randomized to receive either emricasan 50 mg BID or emricasan 5 mg BID or matching placebo BID.

Key facts

Study ID: NCT02686762
Run by: Conatus Pharmaceuticals Inc.
People needed: 318
Starts: 2016-01-26
Expected to finish: 2019-02-28
Last updated by the study team: 2019-08-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female subjects 18 years or older, able to provide written informed consent, and able to understand and willing to comply with the requirements of the study
Histological evidence of definite NASH based on NASH CLinical Research Network (CRN) criteria, as confirmed by the central histopathologist, on a liver biopsy obtained no more than 6 months prior to Day 1
NAFLD Activity Score (NAS) of 4 or greater with a score of at least 1 in each component of the NAS (steatosis scored 0-3, lobular inflammation scored 0-3, ballooning scored 0-2)
Fibrosis stage 1 (limited to 20% of subjects), stage 2, or stage 3 using the NASH CRN Histologic Scoring System
a. Subjects with fibrosis stage 1 must also have diabetes mellitus or metabolic syndrome
Willingness to utilize effective contraception (for both males and females of childbearing potential) from Screening to 4 weeks after the last dose of study drug
If on vitamin E or pioglitazone, subjects must have been on a stable dose for at least 3 months prior to the biopsy (whether historical or qualifying biopsy)

You may not qualify if…

Current or history of significant alcohol consumption, defined as more than 20 g/day for females and more than 30 g/day in males on average, or inability to reliably quantify alcohol consumption based on investigator's judgement
Use of the following drugs (which may have potential hepatotoxic effects) within 6 months prior to Day 1: amiodarone, methotrexate, tamoxifen, valproic acid, estrogens at doses greater than those used for hormone replacement or contraception, anabolic steroids, or systemic glucocorticoids for more than 4 weeks at doses greater than replacement doses
Uncontrolled diabetes (HbA1c ≥9%) within 60 days prior to Day 1
Presence of cirrhosis on liver biopsy (fibrosis stage 4 based on the central histopathologist reading)
Hepatitis and fibrosis more likely related to etiologies other than NASH such as:
alcoholic steatohepatitis
autoimmune hepatitis
hepatitis B virus (HBV) infection
hepatitis C virus (HCV) infection
primary biliary cirrhosis
primary sclerosing cholangitis
Wilson's disease
alpha-1-antitrypsin deficiency
hemochromatosis or iron overload
drug-induced liver disease
other biliary liver disease
ALT or AST >5 times upper limit of normal (ULN) or total bilirubin >1.5 times ULN during screening (unless subject has elevated total bilirubin due to Gilbert's as documented in the medical records)
Alpha-fetoprotein >200 ng/mL
Hemoglobin <10 g/dL
White blood cell count <2.0 x 10\^3/mm3
Estimated creatinine clearance <30 mL/min
Current use of the following medications that are considered significant inhibitors of OATP1B1 and OATP1B3 transporters: atazanavir, cyclosporine, eltrombopag, gemfibrozil, indinavir, lopinavir, ritonavir, rifampin, saquinavir, simeprevir, telaprevir, tipranovir, or some combination of these medications
Symptoms of biliary colic, e.g. due to symptomatic gallstones, within the last 6 months, unless resolved following cholecystectomy
Inability to safely obtain a liver biopsy
Known human immunodeficiency virus (HIV) infection

Where it is running

University of Arizona Clinical and Translational Sciences Research Center — Tucson, Arizona, United States
Preferred Research Partners, Inc. — Little Rock, Arkansas, United States
Fresno Clinical Research Center — Freestone, California, United States
UCLA The Pfleger Liver Institute — Los Angeles, California, United States
Gastrointestinal Biosciences — Los Angeles, California, United States
Surinder Singh Saini, M.D., Inc. — Newport Beach, California, United States
California Liver Research Institute — Pasadena, California, United States
Inland Empire Liver Foundation — Rialto, California, United States
University of California Davis Medical Center — Sacramento, California, United States
University of California San Diego Medical Center — San Diego, California, United States
Cedars Sinai Medical Center — West Hollywood, California, United States
Yale University School of Medicine — New Haven, Connecticut, United States
Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
Howard University — Washington D.C., District of Columbia, United States
UF Hepatology Research at CTRB — Gainesville, Florida, United States
Florida Digestive Health Specialist — Lakewood Rch, Florida, United States
Miami Veterans Administration Healthcare System — Miami, Florida, United States
University of Miami/Schiff Center for Liver Diseases — Miami, Florida, United States
Florida Hospital Orlando Transplant Institute — Orlando, Florida, United States
Tampa General Medical Group — Tampa, Florida, United States
iResearch Atlanta LLC — Decatur, Georgia, United States
Gastrointestinal Specialists of Georgia — Marietta, Georgia, United States
Northwestern Memorial Hospital — Chicago, Illinois, United States
Rush University Medical Center — Chicago, Illinois, United States
University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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