A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-Alcoholic Steatohepatitis

In brief

A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with Non-Alcoholic Steatohepatitis

Key facts

Study ID

NCT03421431

Run by

Enanta Pharmaceuticals, Inc

People needed

134

Starts

2018-04-25

Expected to finish

2019-07-10

Last updated by the study team

2021-09-16

Who can join

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

You may qualify if…

• An informed consent document must be signed and dated by the subject
• Male and female subjects of any ethnic origin between the ages of 18 and 75 years, inclusive
• Male or female with presence of NASH by:
• Histologic evidence on a historical liver biopsy within 24 months of Screening consistent with NASH with fibrosis (no cirrhosis), and elevated ALT at Screening AND Screening MRI PDFF with >8 % steatosis OR
• Phenotypic diagnosis of NASH based on elevated ALT and diagnosis of T2DM or pre-diabetes AND Screening MRI PDFF with >8 % steatosis
• Body mass index (BMI) >25 kg/m2; for Asian-Americans, BMI >23 kg/m2
• Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP-305.
• Subject must be willing and able to adhere to the assessments, visit schedules, prohibitions and restrictions, as described in this protocol

You may not qualify if…

• Laboratory Screening Results:
• Total bilirubin > ULN (normal range 0.2-1.2 mg/dL)
• Total white blood cells (WBC) <3,000 cells/mm3
• Absolute neutrophil count (ANC) <1,500 cells/mm3
• Platelet count <140,000/mm3
• Prothrombin time (international normalized ratio, INR) > 1.2
• Creatine kinase above the upper limit of normal (ULN) except when in relation with intense exercise
• Serum creatinine >2 mg/dL or creatinine clearance <60 ml/min (based on Cockroft Gault method)
• Known history of alpha-1-antitrypsin deficiency
• Use of an experimental treatment for NASH within the past 6 months
• Use of immunosuppressant (eg, corticosteroids) for more than 2 weeks in duration within 1 year prior to Screening and during the course of the study
• Use of experimental or unapproved drugs within a year of Screening
• Any other condition(s) (including cardiovascular diseases) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Principal Investigator (PI)
• Pregnant or nursing females
• Recipients of liver or other organ transplantation or anticipated need for orthotropic organ transplantation in one year as determined by a Model for End-Stage Liver Disease (MELD) Score ≥ 15
• Clinical suspicion of advanced liver disease or cirrhosis
• Coexisting liver or biliary diseases, such as primary sclerosing cholangitis (PSC), choledocholithiasis, acute or chronic hepatitis, autoimmune hepatitis, alcoholic liver disease, acute infection of bile duct system or gall bladder, history of gastrointestinal bleeding (secondary to portal hypertension), cirrhosis
• Suspicion of cancer (eg, liver cancer) with the exception of basal cell carcinoma that has been resected
• Cirrhosis with or without complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma, bilirubin > 2xULN
• Hepatorenal syndrome (type I or II) or Screening serum creatinine > 2 mg/dL (178 μmol/L)
• Prior variceal hemorrhage, uncontrolled encephalopathy, Child-Pugh Class A, B, and C, esophageal varices, or refractory ascites within the previous 6 months of Screening (defined as date informed consent signed)
• Any condition possibly affecting drug absorption (eg, gastrectomy <3 years prior to Screening)
• Subject has received an investigational agent or vaccine within 30 days, or a biological product within 3 months or 5 elimination half-lives (whichever is longer) prior to the planned intake of study drug. NOTE: Flu vaccine will be allowed upon Medical Monitor's approval
• Use of a new statin regimen from Screening and throughout study duration. NOTE: Subjects on a stable dose of statins for at least three months prior to Screening are allowed. No dose modification during the study will be allowed.
• Current use of fibrates. Note: Subjects who discontinued fibrates for at least 3 months before Screening can participate

Where it is running

• Central Arizona Medical Associates — Mesa, Arizona, United States
• Mayo Clinic Specialty Building — Phoenix, Arizona, United States
• Anaheim Clinical Trials — Anaheim, California, United States
• estudy site - Chula Vista — Chula Vista, California, United States
• Southern California Research Center — Coronado, California, United States
• Fresno Clinical Research Center (FCRC) — Fresno, California, United States
• UCSD Altman Clinical and Translational Research Institute — La Jolla, California, United States
• Clinical Trials Research — Lincoln, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• National Research Institute — Los Angeles, California, United States
• Catalina Research Institute, LLC — Montclair, California, United States
• Inland Empire Liver Foundation — Rialto, California, United States
• Southern California Transplantation Institute Research Foundation — San Clemente, California, United States
• Precision Research Institute — San Diego, California, United States
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
• Clinical Research Advantage, Inc. / Colorado Springs Family Practice — Colorado Springs, Colorado, United States
• South Denver Gastroenterology,P.C. — Englewood, Colorado, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Fleming Island Center for Clinical Research — Fleming Island, Florida, United States
• Westside Center for Clinical Research — Jacksonville, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Jacksonville Center for Endoscopy - Southside ; Borland Groover Clinic — Jacksonville, Florida, United States
• Precision Clinical Research, LLC. — Lauderdale Lakes, Florida, United States
• Homestead Medical Research — Miami, Florida, United States
• Radiant Research Incorporated — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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