Clinical Trial Details

Trial ID: L0182
Source ID: NCT03421431
Associated Drug: EDP-305
Title: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis
Acronym: --
Status: Completed
Study Results: Has Results
Results: https://ClinicalTrials.gov/show/NCT03421431/results
Conditions: Non-Alcoholic Steatohepatitis
Interventions: Drug: EDP-305 Dose 1|Drug: EDP-305 Dose 2|Drug: Placebo
Outcome Measures: Mean Change From Baseline (Average) in Alanine Aminotransferase (ALT) at Week 12|Mean Change From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 12|Mean Change From Baseline in Aspartate Aminotransferase to Platelet Ratio Index (APRI) at Week 12|Mean Change From Baseline in Triglycerides (TG) at Week 12|Mean Change From Baseline in Total Cholesterol at Week 12|Mean Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12|Mean Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12|Mean Change From Baseline in Adiponectin at Week 12|Mean Change From Baseline in Apolipoproteins A1 (ApoA-1) at Week 12|Mean Change From Baseline in Apolipoproteins B (ApoB) at Week 12|Mean Change From Baseline in Apolipoproteins C3 (ApoC3) at Week 12|Mean Change From Baseline in Fasting Blood Glucose at Week 12|Mean Change From Baseline in Fasting Insulin at Week 12|Mean Change From Baseline in Homeostasis Model Assessment (HOMA) Index for Nondiabetic Participants at Week 12|Mean Change From Baseline in HOMA Index for Diabetic Participants at Week 12|Mean Change From Baseline in Glycated Hemoglobin (HbA1c) in Participants With T2DM at Week 12|Maximum Plasma Concentration (Cmax) of EDP-305 on Day 1 and Week 12|Time to Reach Maximum Plasma Concentration (Tmax) of EDP-305 on Day 1 and at Week 12|Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC[Last]) of EDP-305 on Day 1 and at Week 12|Cmax of EP-022571 on Day 1 and at Week 12|Tmax of EP-022571 on Day 1 and at Week 12|AUC(Last) of EP-022571 on Day 1 and at Week 12|Cmax of EP-022572 on Day 1 and at Week 12|Tmax of EP-022572 on Day 1 and at Week 12|AUC(Last) of EP-022572 on Day 1 and at Week 12|Cmax of EP-022679 on Day 1 and at Week 12|Tmax of EP-022679 on Day 1 and at Week 12|AUC(Last) of EP-022679 on Day 1 and at Week 12|Mean Change From Baseline in Body Weight at Week 12|Mean Change From Baseline in Waist to Hip (WTH) Ratio at Week 12|Mean Change From Baseline in Fibroblast Growth Factor 19 (FGF19) by Nominal Timepoint (Intensive Pharmacodynamic [PD] Samples) at Week 12|Mean Change From Baseline in FGF19 by Bin Timepoint (Sparse PD Samples) at Week 12|Mean Change From Baseline in 7a-Hydroxy-4-Cholestene-3-One (C4) by Nominal Timepoint (Intensive PD Samples) at Week 12|Mean Change From Baseline in C4 by Bin Timepoint (Sparse PD Samples) at Week 12|Mean Change From Baseline in Bile Acid (BA) by Nominal Timepoint (Intensive PD Samples) at Week 12|Mean Change From Baseline in BA by Bin Timepoint (Sparse PD Samples) at Week 12
Sponsor/Collaborators: Enanta Pharmaceuticals|ICON Clinical Research|Triangle Biostatistics
Gender: All
Age: 18 Years to 75 Years ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 134
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
Start Date: April 25, 2018
Completion Date: July 10, 2019
Results First Posted: September 16, 2021
Last Update Posted: September 16, 2021
Locations: 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|Ocean Blue Medical Research Center, Inc, Miami Springs, 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|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, Saint Louis, Missouri, United States|AGA Clinical Research Associates, LLC, Egg Harbor Township, 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 H??spital 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
URL: https://ClinicalTrials.gov/show/NCT03421431

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D117 EDP-305 Chemical drug -- FXR agonist Enhance lipid metabolism Under clinical trials Details
D010 Amoxicillin Chemical drug DB01060 -- -- Under clinical trials Details
D094 Cysteamine Chemical drug DB00847 GSS stimulant Renal drug Under clinical trials Details
D095 Cysteamine bitartrate Chemical drug DB00847 -- -- Under clinical trials Details
D182 Insulin Biological drug DB00030 INSR agonist; CPE modulator&product of -- Under clinical trials Details
D199 L-alanine Chemical drug DB00160 KYNU -- Failed in clinical trials Details
D223 Metabolic Cofactor Supplementation Supplement -- -- -- Under clinical trials Details
D316 S-adenosyl-L-methionine Chemical drug DB00118 GNMT cofactor Antiviral Under clinical trials Details