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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03421431
Recruitment Status : Completed
First Posted : February 5, 2018
Last Update Posted : October 10, 2019
Sponsor:
Collaborators:
ICON Clinical Research
Triangle Biostatistics
Information provided by (Responsible Party):
Enanta Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Non-Alcoholic Steatohepatitis Drug: EDP-305 Dose 1 Drug: EDP-305 Dose 2 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Dose Ranging, Randomized, Double Blind, and Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
Actual Study Start Date : April 25, 2018
Actual Primary Completion Date : June 14, 2019
Actual Study Completion Date : July 10, 2019


Arm Intervention/treatment
Experimental: EDP-305 Dose 1
Subjects will take 2 tablets once a day orally for 12 weeks
Drug: EDP-305 Dose 1
Two tablets daily for 12 weeks

Experimental: EDP-305 Dose 2
Subjects will take 2 tablets once a day orally for 12 weeks
Drug: EDP-305 Dose 2
Two tablets daily for 12 weeks

Placebo Comparator: Placebo
Subjects will take 2 tablets once a day orally for 12 weeks
Drug: Placebo
Two tablets daily for 12 weeks




Primary Outcome Measures :
  1. Change from baseline in ALT levels at Week 12 [ Time Frame: Measurement at Week 12 ]
  2. Safety as measured by frequency of adverse events (AEs), serious AEs, and AEs leading to discontinuation through Week 12 [ Time Frame: Up to 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Clinically significant history of drug sensitivity or allergy, as determined by the PI
  • Uncontrolled diabetes mellitus (ie, HbA1c ≥9% or higher) 60 days prior to Day 1
  • Subjects with contraindications to MRI imaging, or not being able to have the MRI performed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421431


  Hide Study Locations
Locations
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United States, Arizona
Radiant Research Incorporated
Chandler, Arizona, United States, 85224
Central Arizona Medical Associates
Mesa, Arizona, United States, 58206
Mayo Clinic Specialty Building
Phoenix, Arizona, United States, 85054
United States, California
Anaheim Clinical Trials
Anaheim, California, United States, 92801
estudy site - Chula Vista
Chula Vista, California, United States, 91911
Southern California Research Center
Coronado, California, United States, 92118
Fresno Clinical Research Center (FCRC)
Fresno, California, United States, 93720
UCSD Altman Clinical and Translational Research Institute
La Jolla, California, United States, 92037
Clinical Trials Research
Lincoln, California, United States, 95648
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
National Research Institute
Los Angeles, California, United States, 90057
Catalina Research Institute, LLC
Montclair, California, United States, 91763
Inland Empire Liver Foundation
Rialto, California, United States, 92377
Southern California Transplantation Institute Research Foundation
San Clemente, California, United States, 92673
Precision Research Institute
San Diego, California, United States, 92114
United States, Colorado
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States, 80907
Clinical Research Advantage, Inc. / Colorado Springs Family Practice
Colorado Springs, Colorado, United States, 80909
South Denver Gastroenterology,P.C.
Englewood, Colorado, United States, 80113
United States, Florida
Avail Clinical Research, LLC
DeLand, Florida, United States, 32720
Fleming Island Center for Clinical Research
Fleming Island, Florida, United States, 32003
Westside Center for Clinical Research
Jacksonville, Florida, United States, 32205
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Jacksonville Center for Endoscopy - Southside ; Borland Groover Clinic
Jacksonville, Florida, United States, 32226
Precision Clinical Research, LLC.
Lauderdale Lakes, Florida, United States, 33319
Ocean Blue Medical Research Center, Inc
Miami Springs, Florida, United States, 33166
Homestead Medical Research
Miami, Florida, United States, 33030
Research Associates of South Florida, LLC
Miami, Florida, United States, 33134
Florida Advanced Medical Research, Inc.
Miami, Florida, United States, 33144
Clinical Neuroscience Solutions Inc.
Orlando, Florida, United States, 32801
Advanced Gastroenterology Associates, LLC
Palm Harbor, Florida, United States, 34684
United States, Georgia
Piedmont Atlanta Hospital
Atlanta, Georgia, United States, 30309
Gastrointestinal Specialists Of Georgia
Marietta, Georgia, United States, 30060
United States, Illinois
Feinberg School of Medicine Northwestern University
Chicago, Illinois, United States, 60611
United States, Indiana
Midwest Institute For Clinical Research
Indianapolis, Indiana, United States, 46260
United States, Kansas
WestGlen Gastrointestinal Consultants, PA
Shawnee Mission, Kansas, United States, 66217
United States, Louisiana
Oshsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Digestive Disease Associates, PA
Catonsville, Maryland, United States, 21228
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Kansas City Research Institute
Kansas City, Missouri, United States, 64131
Saint Louis University
Saint Louis, Missouri, United States, 63104
United States, New Jersey
AGA Clinical Research Associates, LLC
Egg Harbor Township, New Jersey, United States, 08234
United States, New York
Northwell Health Inc.
Manhasset, New York, United States, 11030
NYU Langone Medical Center - The Center for Musculoskeletal Care (CMC)
New York, New York, United States, 10016
Weill Cornell Medical College
New York, New York, United States, 10021
United States, North Carolina
Carolinas Medical Center Transplant Center/Center for Liver Disease
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 27710
Carolinas Center for Liver Disease / Carolinas Health Care System
Huntersville, North Carolina, United States, 28078
United States, Ohio
Sterling Research Group, Ltd.
Cincinnati, Ohio, United States, 45219
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pittsburgh Medical Center - Center for Liver Diseases
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
University Of Tennessee Health Science Center
Memphis, Tennessee, United States, 38104
Quality Medical Research, PLLC
Nashville, Tennessee, United States, 37211
United States, Texas
Texas Clinical Research Institute
Arlington, Texas, United States, 76012
Texas Diabetes & Endocrinology
Austin, Texas, United States, 78749
Dallas Diabetes Research Center
Dallas, Texas, United States, 75230
DHAT Research Institute
Garland, Texas, United States, 75044
Baylor College of Medicine - Advanced Liver Therapies
Houston, Texas, United States, 77030
Texas Liver Institute
San Antonio, Texas, United States, 78215
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
Radiant Research, Inc.
San Antonio, Texas, United States, 78229
United States, Utah
Wasatch Peak Family Practice/Radiant Research, Inc
Layton, Utah, United States, 84041
Radiant Research, Inc.
Murray, Utah, United States, 84123
United States, Virginia
Gastroenterology Associates, PC
Gainesville, Virginia, United States, 20155
Bon Secours St. Mary's Hospital of Richmond, Inc
Newport News, Virginia, United States, 23602
The Gastroenterology Group, PC
Reston, Virginia, United States, 20191
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Swedish Medical Center-Swedish Organ Transplant and Liver Center
Seattle, Washington, United States, 98104
University of Washington / Harborview Medical Center
Seattle, Washington, United States, 98104
United States, Wisconsin
Mayo Clinic Health System - Franciscan Healthcare
La Crosse, Wisconsin, United States, 54601
Canada, Ontario
Aggarwal and Associates Limited
Brampton, Ontario, Canada, L6T OG1
Toronto Liver Centre
Toronto, Ontario, Canada, M6H3M1
Canada, Quebec
Clinique de recherche Medpharmgene
Montreal, Quebec, Canada, H2K 1H2
Chronic Viral Illness Service McGill University Health Center/Royal Victoria
Montreal, Quebec, Canada, H4A 3JI
France
Hopital Pitie Salpetriere
Paris, France, Cedex 13
CHU de Bordeaux - GH Sud - Hoital Haut Leveque
Pessac, France, 33604
CHU de Strasbourg - Nouvel Hôspital Civil
Strasbourg, France, 67000
New Zealand
Auckland Clinical Studies Limited
Auckland, New Zealand, 1010
Puerto Rico
Latin Clinical Trial Center
San Juan, Puerto Rico, PR 00909
United Kingdom
Addenbrookes Hospital (AH)-Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
King's College Hospital NHS Foundation
London, Greater London, United Kingdom, SE5 9RS
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Sponsors and Collaborators
Enanta Pharmaceuticals
ICON Clinical Research
Triangle Biostatistics
Investigators
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Study Director: Nathalie Adda, MD Enanta Pharmaceuticals Inc.

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Responsible Party: Enanta Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03421431     History of Changes
Other Study ID Numbers: EDP 305-101
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Enanta Pharmaceuticals:
NASH
Non-Alcoholic Steatohepatitis (NASH)
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases