A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis
NCT ID: NCT03421431
Last Updated: 2021-09-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
134 participants
INTERVENTIONAL
2018-04-25
2019-07-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of EDP-305 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers
NCT03207425
A Study of EDP 305 in Healthy Subjects and Subjects With Presumptive NAFLD
NCT02918929
A Randomized, Double-blind Study to Assess the Safety and Efficacy of EDP-305 in Subjects With Liver-biopsy Proven NASH
NCT04378010
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis
NCT03394924
Absorption, Metabolism and Excretion (AME) Study of [14C]EDP-305 in Healthy Male Subjects
NCT03748628
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
EDP-305 Dose 1
Subjects will take 2 tablets once a day orally for 12 weeks
EDP-305 Dose 1
Two tablets daily for 12 weeks
EDP-305 Dose 2
Subjects will take 2 tablets once a day orally for 12 weeks
EDP-305 Dose 2
Two tablets daily for 12 weeks
Placebo
Subjects will take 2 tablets once a day orally for 12 weeks
Placebo
Two tablets daily for 12 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
EDP-305 Dose 1
Two tablets daily for 12 weeks
EDP-305 Dose 2
Two tablets daily for 12 weeks
Placebo
Two tablets daily for 12 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ICON Clinical Research
INDUSTRY
Triangle Biostatistics, LLC
INDUSTRY
Enanta Pharmaceuticals, Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nathalie Adda, MD
Role: STUDY_DIRECTOR
Enanta Pharmaceuticals, Inc
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Radiant Research Incorporated
Chandler, Arizona, United States
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
Research Associates of South Florida, LLC
Miami, Florida, United States
Florida Advanced Medical Research, Inc.
Miami, Florida, United States
Ocean Blue Medical Research Center, Inc
Miami Springs, Florida, United States
Clinical Neuroscience Solutions Inc.
Orlando, Florida, United States
Advanced Gastroenterology Associates, LLC
Palm Harbor, Florida, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
Gastrointestinal Specialists Of Georgia
Marietta, Georgia, United States
Feinberg School of Medicine Northwestern University
Chicago, Illinois, United States
Midwest Institute For Clinical Research
Indianapolis, Indiana, United States
WestGlen Gastrointestinal Consultants, PA
Shawnee Mission, Kansas, United States
Oshsner Clinic Foundation
New Orleans, Louisiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
Digestive Disease Associates, PA
Catonsville, Maryland, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Kansas City Research Institute
Kansas City, Missouri, United States
Saint Louis University
St Louis, Missouri, United States
AGA Clinical Research Associates, LLC
Egg Harbor, New Jersey, United States
Northwell Health Inc.
Manhasset, New York, United States
NYU Langone Medical Center - The Center for Musculoskeletal Care (CMC)
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Carolinas Medical Center Transplant Center/Center for Liver Disease
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Carolinas Center for Liver Disease / Carolinas Health Care System
Huntersville, North Carolina, United States
Sterling Research Group, Ltd.
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pittsburgh Medical Center - Center for Liver Diseases
Pittsburgh, Pennsylvania, United States
University Of Tennessee Health Science Center
Memphis, Tennessee, United States
Quality Medical Research, PLLC
Nashville, Tennessee, United States
Texas Clinical Research Institute
Arlington, Texas, United States
Texas Diabetes & Endocrinology
Austin, Texas, United States
Dallas Diabetes Research Center
Dallas, Texas, United States
DHAT Research Institute
Garland, Texas, United States
Baylor College of Medicine - Advanced Liver Therapies
Houston, Texas, United States
Texas Liver Institute
San Antonio, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Radiant Research, Inc.
San Antonio, Texas, United States
Wasatch Peak Family Practice/Radiant Research, Inc
Layton, Utah, United States
Radiant Research, Inc.
Murray, Utah, United States
Gastroenterology Associates, PC
Gainesville, Virginia, United States
Bon Secours St. Mary's Hospital of Richmond, Inc
Newport News, Virginia, United States
The Gastroenterology Group, PC
Reston, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Swedish Medical Center-Swedish Organ Transplant and Liver Center
Seattle, Washington, United States
University of Washington / Harborview Medical Center
Seattle, Washington, United States
Mayo Clinic Health System - Franciscan Healthcare
La Crosse, Wisconsin, United States
Aggarwal and Associates Limited
Brampton, Ontario, Canada
Toronto Liver Centre
Toronto, Ontario, Canada
Clinique de recherche Medpharmgene
Montreal, Quebec, Canada
Chronic Viral Illness Service McGill University Health Center/Royal Victoria
Montreal, Quebec, Canada
Hopital Pitie Salpetriere
Paris, , France
CHU de Bordeaux - GH Sud - Hoital Haut Leveque
Pessac, , France
CHU de Strasbourg - Nouvel Hôspital Civil
Strasbourg, , France
Auckland Clinical Studies Limited
Auckland, , New Zealand
Latin Clinical Trial Center
San Juan, , Puerto Rico
Addenbrookes Hospital (AH)-Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
King's College Hospital NHS Foundation
London, Greater London, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ratziu V, Rinella ME, Neuschwander-Tetri BA, Lawitz E, Denham D, Kayali Z, Sheikh A, Kowdley KV, Desta T, Elkhashab M, DeGrauw J, Goodwin B, Ahmad A, Adda N. EDP-305 in patients with NASH: A phase II double-blind placebo-controlled dose-ranging study. J Hepatol. 2022 Mar;76(3):506-517. doi: 10.1016/j.jhep.2021.10.018. Epub 2021 Nov 3.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EDP 305-101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.