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

PHASE2CompletedINTERVENTIONAL
Enrollment

134

Participants

Timeline

Start Date

April 25, 2018

Primary Completion Date

June 14, 2019

Study Completion Date

July 10, 2019

Conditions
Non-Alcoholic Steatohepatitis
Interventions
DRUG

EDP-305 Dose 1

Two tablets daily for 12 weeks

DRUG

EDP-305 Dose 2

Two tablets daily for 12 weeks

DRUG

Placebo

Two tablets daily for 12 weeks

Trial Locations (82)

1010

Auckland Clinical Studies Limited, Auckland

10016

NYU Langone Medical Center - The Center for Musculoskeletal Care (CMC), New York

10021

Weill Cornell Medical College, New York

11030

Northwell Health Inc., Manhasset

15213

University of Pittsburgh Medical Center - Center for Liver Diseases, Pittsburgh

20155

Gastroenterology Associates, PC, Gainesville

20191

The Gastroenterology Group, PC, Reston

21202

Mercy Medical Center, Baltimore

21228

Digestive Disease Associates, PA, Catonsville

23602

Bon Secours St. Mary's Hospital of Richmond, Inc, Newport News

27710

Duke University Medical Center, Durham

28078

Carolinas Center for Liver Disease / Carolinas Health Care System, Huntersville

28204

Carolinas Medical Center Transplant Center/Center for Liver Disease, Charlotte

30060

Gastrointestinal Specialists Of Georgia, Marietta

30309

Piedmont Atlanta Hospital, Atlanta

32003

Fleming Island Center for Clinical Research, Fleming Island

32205

Westside Center for Clinical Research, Jacksonville

32216

Jacksonville Center for Clinical Research, Jacksonville

32226

Jacksonville Center for Endoscopy - Southside ; Borland Groover Clinic, Jacksonville

32720

Avail Clinical Research, LLC, DeLand

32801

Clinical Neuroscience Solutions Inc., Orlando

33030

Homestead Medical Research, Miami

33134

Research Associates of South Florida, LLC, Miami

33144

Florida Advanced Medical Research, Inc., Miami

33166

Ocean Blue Medical Research Center, Inc, Miami Springs

33319

Precision Clinical Research, LLC., Lauderdale Lakes

33604

CHU de Bordeaux - GH Sud - Hoital Haut Leveque, Pessac

34684

Advanced Gastroenterology Associates, LLC, Palm Harbor

37211

Quality Medical Research, PLLC, Nashville

38104

University Of Tennessee Health Science Center, Memphis

44195

Cleveland Clinic, Cleveland

45219

Sterling Research Group, Ltd., Cincinnati

46260

Midwest Institute For Clinical Research, Indianapolis

48109

University of Michigan Health System, Ann Arbor

54601

Mayo Clinic Health System - Franciscan Healthcare, La Crosse

58206

Central Arizona Medical Associates, Mesa

60611

Feinberg School of Medicine Northwestern University, Chicago

63104

Saint Louis University, St Louis

64131

Kansas City Research Institute, Kansas City

66217

WestGlen Gastrointestinal Consultants, PA, Shawnee Mission

67000

CHU de Strasbourg - Nouvel Hôspital Civil, Strasbourg

70121

Oshsner Clinic Foundation, New Orleans

75044

DHAT Research Institute, Garland

75230

Dallas Diabetes Research Center, Dallas

76012

Texas Clinical Research Institute, Arlington

77030

Baylor College of Medicine - Advanced Liver Therapies, Houston

78215

Texas Liver Institute, San Antonio

78229

Clinical Trials of Texas, Inc., San Antonio

Radiant Research, Inc., San Antonio

78749

Texas Diabetes & Endocrinology, Austin

80113

South Denver Gastroenterology,P.C., Englewood

80907

Peak Gastroenterology Associates, Colorado Springs

80909

Clinical Research Advantage, Inc. / Colorado Springs Family Practice, Colorado Springs

84041

Wasatch Peak Family Practice/Radiant Research, Inc, Layton

84123

Radiant Research, Inc., Murray

85054

Mayo Clinic Specialty Building, Phoenix

85224

Radiant Research Incorporated, Chandler

90048

Cedars-Sinai Medical Center, Los Angeles

90057

National Research Institute, Los Angeles

91763

Catalina Research Institute, LLC, Montclair

91911

estudy site - Chula Vista, Chula Vista

92037

UCSD Altman Clinical and Translational Research Institute, La Jolla

92114

Precision Research Institute, San Diego

92118

Southern California Research Center, Coronado

92377

Inland Empire Liver Foundation, Rialto

92673

Southern California Transplantation Institute Research Foundation, San Clemente

92801

Anaheim Clinical Trials, Anaheim

93720

Fresno Clinical Research Center (FCRC), Fresno

95648

Clinical Trials Research, Lincoln

98101

Virginia Mason Medical Center, Seattle

98104

Swedish Medical Center-Swedish Organ Transplant and Liver Center, Seattle

University of Washington / Harborview Medical Center, Seattle

08234

AGA Clinical Research Associates, LLC, Egg Harbor

L6T OG1

Aggarwal and Associates Limited, Brampton

M6H3M1

Toronto Liver Centre, Toronto

H2K 1H2

Clinique de recherche Medpharmgene, Montreal

H4A 3JI

Chronic Viral Illness Service McGill University Health Center/Royal Victoria, Montreal

Cedex 13

Hopital Pitie Salpetriere, Paris

PR 00909

Latin Clinical Trial Center, San Juan

CB2 0QQ

Addenbrookes Hospital (AH)-Cambridge University Hospitals NHS Foundation Trust, Cambridge

SE5 9RS

King's College Hospital NHS Foundation, London

NG7 2UH

Nottingham University Hospitals NHS Trust, Nottingham

Sponsors
All Listed Sponsors
collaborator

ICON Clinical Research

INDUSTRY

collaborator

Triangle Biostatistics, LLC

INDUSTRY

lead

Enanta Pharmaceuticals, Inc

INDUSTRY