Back to resultsA Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis
Primary Purpose
Non-Alcoholic Steatohepatitis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
EDP-305 Dose 1
EDP-305 Dose 2
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non-Alcoholic Steatohepatitis focused on measuring NASH, Non-Alcoholic Steatohepatitis (NASH)
Eligibility 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
Sites / Locations
- Radiant Research Incorporated
- Central Arizona Medical Associates
- Mayo Clinic Specialty Building
- Anaheim Clinical Trials
- estudy site - Chula Vista
- Southern California Research Center
- Fresno Clinical Research Center (FCRC)
- UCSD Altman Clinical and Translational Research Institute
- Clinical Trials Research
- Cedars-Sinai Medical Center
- National Research Institute
- Catalina Research Institute, LLC
- Inland Empire Liver Foundation
- Southern California Transplantation Institute Research Foundation
- Precision Research Institute
- Peak Gastroenterology Associates
- Clinical Research Advantage, Inc. / Colorado Springs Family Practice
- South Denver Gastroenterology,P.C.
- Avail Clinical Research, LLC
- Fleming Island Center for Clinical Research
- Westside Center for Clinical Research
- Jacksonville Center for Clinical Research
- Jacksonville Center for Endoscopy - Southside ; Borland Groover Clinic
- Precision Clinical Research, LLC.
- Ocean Blue Medical Research Center, Inc
- Homestead Medical Research
- Research Associates of South Florida, LLC
- Florida Advanced Medical Research, Inc.
- Clinical Neuroscience Solutions Inc.
- Advanced Gastroenterology Associates, LLC
- Piedmont Atlanta Hospital
- Gastrointestinal Specialists Of Georgia
- Feinberg School of Medicine Northwestern University
- Midwest Institute For Clinical Research
- WestGlen Gastrointestinal Consultants, PA
- Oshsner Clinic Foundation
- Mercy Medical Center
- Digestive Disease Associates, PA
- University of Michigan Health System
- Kansas City Research Institute
- Saint Louis University
- AGA Clinical Research Associates, LLC
- Northwell Health Inc.
- NYU Langone Medical Center - The Center for Musculoskeletal Care (CMC)
- Weill Cornell Medical College
- Carolinas Medical Center Transplant Center/Center for Liver Disease
- Duke University Medical Center
- Carolinas Center for Liver Disease / Carolinas Health Care System
- Sterling Research Group, Ltd.
- Cleveland Clinic
- University of Pittsburgh Medical Center - Center for Liver Diseases
- University Of Tennessee Health Science Center
- Quality Medical Research, PLLC
- Texas Clinical Research Institute
- Texas Diabetes & Endocrinology
- Dallas Diabetes Research Center
- DHAT Research Institute
- Baylor College of Medicine - Advanced Liver Therapies
- Texas Liver Institute
- Clinical Trials of Texas, Inc.
- Radiant Research, Inc.
- Wasatch Peak Family Practice/Radiant Research, Inc
- Radiant Research, Inc.
- Gastroenterology Associates, PC
- Bon Secours St. Mary's Hospital of Richmond, Inc
- The Gastroenterology Group, PC
- Virginia Mason Medical Center
- Swedish Medical Center-Swedish Organ Transplant and Liver Center
- University of Washington / Harborview Medical Center
- Mayo Clinic Health System - Franciscan Healthcare
- Aggarwal and Associates Limited
- Toronto Liver Centre
- Clinique de recherche Medpharmgene
- Chronic Viral Illness Service McGill University Health Center/Royal Victoria
- Hopital Pitie Salpetriere
- CHU de Bordeaux - GH Sud - Hoital Haut Leveque
- CHU de Strasbourg - Nouvel Hôspital Civil
- Auckland Clinical Studies Limited
- Latin Clinical Trial Center
- Addenbrookes Hospital (AH)-Cambridge University Hospitals NHS Foundation Trust
- King's College Hospital NHS Foundation
- Nottingham University Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
EDP-305 Dose 1
EDP-305 Dose 2
Placebo
Arm Description
Subjects will take 2 tablets once a day orally for 12 weeks
Subjects will take 2 tablets once a day orally for 12 weeks
Subjects will take 2 tablets once a day orally for 12 weeks
Outcomes
Primary Outcome Measures
Mean Change From Baseline (Average) in Alanine Aminotransferase (ALT) at Week 12
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the ALT level. Baseline refers to the average of the screening and the Day 1 values; if either the screening or Day 1 values were missing, the non-missing value was used. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Secondary Outcome Measures
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
The liver fat percentage was assessed by MRI-PDFF, which is an established method that enables the quantification of fat content in the liver; the value of liver fat is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Mean Change From Baseline in Aspartate Aminotransferase to Platelet Ratio Index (APRI) at Week 12
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the aspartate aminotransferase (AST) level and platelet count. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. The APRI score (AST to platelet ratio index) is an index comprised of biochemical values and is used to determine the degree of hepatic fibrosis. APRI is calculated from the level of AST measured in a blood test (international units per liter [IU/L]) and platelet count (10^9/L) according to the following formula:
APRI = ([AST value in IU/L / upper limit of the normal range of AST] / [platelet count in 10^9/L]) × 100.
In general, APRI scores range from 0 to >2.0, where scores <0.5 indicate no significant fibrosis, scores >1.5 indicate significant fibrosis, and scores >2.0 have been shown to be best correlated with the presence of cirrhosis. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Mean Change From Baseline in Triglycerides (TG) at Week 12
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the TG level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Mean Change From Baseline in Total Cholesterol at Week 12
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the total cholesterol level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Mean Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the HDL-C level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Mean Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the LDL-C level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Mean Change From Baseline in Adiponectin at Week 12
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the adiponectin level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Mean Change From Baseline in Apolipoproteins A1 (ApoA-1) at Week 12
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the ApoA-1 level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Mean Change From Baseline in Apolipoproteins B (ApoB) at Week 12
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the ApoB level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Mean Change From Baseline in Apolipoproteins C3 (ApoC3) at Week 12
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the ApoC3 level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Mean Change From Baseline in Fasting Blood Glucose at Week 12
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the fasting glucose level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Mean Change From Baseline in Fasting Insulin at Week 12
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the fasting insulin (in micro International units per milliliter [μIU/mL]). Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Mean Change From Baseline in Homeostasis Model Assessment (HOMA) Index for Nondiabetic Participants at Week 12
Blood samples were collected at specific timepoints for the laboratory evaluation; from the results of fasting glucose and insulin, an insulin resistance (IR) was estimated for the nondiabetic participants using the HOMA-IR computer algorithm. A higher HOMA-IR indicates a higher degree of insulin resistance. Participants who were not considered as having type 2 diabetes mellitus (T2DM) were identified as nondiabetic. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Mean Change From Baseline in HOMA Index for Diabetic Participants at Week 12
Blood samples were collected at specific timepoints for the laboratory evaluation; from the results of fasting glucose and insulin, an insulin resistance (IR) was estimated for the nondiabetic participants using the HOMA-IR computer algorithm. A higher HOMA-IR indicates a higher degree of insulin resistance. Participants who were considered as having T2DM were identified as diabetic. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Mean Change From Baseline in Glycated Hemoglobin (HbA1c) in Participants With T2DM at Week 12
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the HbA1c. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Maximum Plasma Concentration (Cmax) of EDP-305 on Day 1 and Week 12
The Cmax is the maximum observed plasma concentration, which was measured for EDP-305 on Day 1 and Week 12 for the samples collected according to the intensive sampling scheme for the participants in the Pharmacokinetic (PK) Population.
Time to Reach Maximum Plasma Concentration (Tmax) of EDP-305 on Day 1 and at Week 12
The Tmax was measured for EDP-305 on Day 1 and at Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.
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
AUC(last) is defined as the area under the plasma concentration-time curve from time zero to time the last quantifiable concentration, computed using the linear up/log down trapezoidal rule. AUC(last) was computed for EDP-305 on Day 1 and Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.
Cmax of EP-022571 on Day 1 and at Week 12
The Cmax is the maximum observed plasma concentration, which was measured for EP-022571 (a metabolite of EDP-305) on Day 1 and Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.
Tmax of EP-022571 on Day 1 and at Week 12
The Tmax was measured for EP-022571 (a metabolite of EDP-305) on Day 1 and at Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.
AUC(Last) of EP-022571 on Day 1 and at Week 12
AUC(last) is defined as the area under the plasma concentration-time curve from time zero to time the last quantifiable concentration, computed using the linear up/log down trapezoidal rule. AUC(last) was computed for EP-022571 (a metabolite of EDP-305) on Day 1 and Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.
Cmax of EP-022572 on Day 1 and at Week 12
The Cmax is the maximum observed plasma concentration, which was measured for EP-022572 (a metabolite of EDP-305) on Day 1 and Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.
Tmax of EP-022572 on Day 1 and at Week 12
The Tmax was measured for EP-022572 (a metabolite of EDP-305) on Day 1 and at Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.
AUC(Last) of EP-022572 on Day 1 and at Week 12
AUC(last) is defined as the area under the plasma concentration-time curve from time zero to time the last quantifiable concentration, computed using the linear up/log down trapezoidal rule. AUC(last) was computed for EP-022572 (a metabolite of EDP-305) on Day 1 and Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.
Cmax of EP-022679 on Day 1 and at Week 12
The Cmax is the maximum observed plasma concentration, which was measured for EP-022679 (a metabolite of EDP-305) on Day 1 and Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.
Tmax of EP-022679 on Day 1 and at Week 12
The Tmax was measured for EP-022679 (a metabolite of EDP-305) on Day 1 and at Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.
AUC(Last) of EP-022679 on Day 1 and at Week 12
AUC(last) is defined as the area under the plasma concentration-time curve from time zero to time the last quantifiable concentration, computed using the linear up/log down trapezoidal rule. AUC(last) was computed for EP-022679 (a metabolite of EDP-305) on Day 1 and Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.
Mean Change From Baseline in Body Weight at Week 12
Body weight was measured at specific timepoints for the participants. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Mean Change From Baseline in Waist to Hip (WTH) Ratio at Week 12
The WTH ratio is calculated as the ratio of waist to hip circumference, which was measured at specific timepoints. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Mean Change From Baseline in Fibroblast Growth Factor 19 (FGF19) by Nominal Timepoint (Intensive Pharmacodynamic [PD] Samples) at Week 12
Blood samples were collected according to the intensive sampling scheme at specific timepoints to assess the PD marker: FGF19. Baseline refers to the last non-missing predose value collected prior to the most recent dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Mean Change From Baseline in FGF19 by Bin Timepoint (Sparse PD Samples) at Week 12
Blood samples were collected according to the sparse sampling scheme at specific timepoints to assess the PD marker: FGF19. Baseline refers to the last non-missing predose value collected prior to the most recent dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Mean Change From Baseline in 7a-Hydroxy-4-Cholestene-3-One (C4) by Nominal Timepoint (Intensive PD Samples) at Week 12
Blood samples were collected according to the intensive sampling scheme at specific timepoints to assess the PD marker: C4. Baseline refers to the last non-missing predose value collected prior to the most recent dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Mean Change From Baseline in C4 by Bin Timepoint (Sparse PD Samples) at Week 12
Blood samples were collected according to the sparse sampling scheme at specific timepoints to assess the PD marker: C4. Baseline refers to the last non-missing predose value collected prior to the most recent dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Mean Change From Baseline in Bile Acid (BA) by Nominal Timepoint (Intensive PD Samples) at Week 12
Blood samples were collected according to the intensive sampling scheme at specific timepoints to assess the PD marker: BA. Baseline refers to the last non-missing predose value collected prior to the most recent dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Mean Change From Baseline in BA by Bin Timepoint (Sparse PD Samples) at Week 12
Blood samples were collected according to the sparse sampling scheme at specific timepoints to assess the PD marker: BA. Baseline refers to the last non-missing predose value collected prior to the most recent dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Full Information
NCT ID
NCT03421431
First Posted
January 29, 2018
Last Updated
August 19, 2021
Sponsor
Enanta Pharmaceuticals, Inc
Collaborators
ICON Clinical Research, Triangle Biostatistics
1. Study Identification
Unique Protocol Identification Number
NCT03421431
Brief Title
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
June 14, 2019 (Actual)
Study Completion Date
July 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enanta Pharmaceuticals, Inc
Collaborators
ICON Clinical Research, Triangle Biostatistics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with Non-Alcoholic Steatohepatitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Steatohepatitis
Keywords
NASH, Non-Alcoholic Steatohepatitis (NASH)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EDP-305 Dose 1
Arm Type
Experimental
Arm Description
Subjects will take 2 tablets once a day orally for 12 weeks
Arm Title
EDP-305 Dose 2
Arm Type
Experimental
Arm Description
Subjects will take 2 tablets once a day orally for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will take 2 tablets once a day orally for 12 weeks
Intervention Type
Drug
Intervention Name(s)
EDP-305 Dose 1
Intervention Description
Two tablets daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
EDP-305 Dose 2
Intervention Description
Two tablets daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Two tablets daily for 12 weeks
Primary Outcome Measure Information:
Title
Mean Change From Baseline (Average) in Alanine Aminotransferase (ALT) at Week 12
Description
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the ALT level. Baseline refers to the average of the screening and the Day 1 values; if either the screening or Day 1 values were missing, the non-missing value was used. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
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
Description
The liver fat percentage was assessed by MRI-PDFF, which is an established method that enables the quantification of fat content in the liver; the value of liver fat is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Time Frame
Baseline and Week 12
Title
Mean Change From Baseline in Aspartate Aminotransferase to Platelet Ratio Index (APRI) at Week 12
Description
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the aspartate aminotransferase (AST) level and platelet count. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. The APRI score (AST to platelet ratio index) is an index comprised of biochemical values and is used to determine the degree of hepatic fibrosis. APRI is calculated from the level of AST measured in a blood test (international units per liter [IU/L]) and platelet count (10^9/L) according to the following formula:
APRI = ([AST value in IU/L / upper limit of the normal range of AST] / [platelet count in 10^9/L]) × 100.
In general, APRI scores range from 0 to >2.0, where scores <0.5 indicate no significant fibrosis, scores >1.5 indicate significant fibrosis, and scores >2.0 have been shown to be best correlated with the presence of cirrhosis. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Time Frame
Baseline and Week 12
Title
Mean Change From Baseline in Triglycerides (TG) at Week 12
Description
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the TG level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Time Frame
Baseline and Week 12
Title
Mean Change From Baseline in Total Cholesterol at Week 12
Description
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the total cholesterol level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Time Frame
Baseline and Week 12
Title
Mean Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12
Description
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the HDL-C level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Time Frame
Baseline and Week 12
Title
Mean Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Description
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the LDL-C level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Time Frame
Baseline and Week 12
Title
Mean Change From Baseline in Adiponectin at Week 12
Description
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the adiponectin level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Time Frame
Baseline and Week 12
Title
Mean Change From Baseline in Apolipoproteins A1 (ApoA-1) at Week 12
Description
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the ApoA-1 level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Time Frame
Baseline and Week 12
Title
Mean Change From Baseline in Apolipoproteins B (ApoB) at Week 12
Description
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the ApoB level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Time Frame
Baseline and Week 12
Title
Mean Change From Baseline in Apolipoproteins C3 (ApoC3) at Week 12
Description
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the ApoC3 level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Time Frame
Baseline and Week 12
Title
Mean Change From Baseline in Fasting Blood Glucose at Week 12
Description
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the fasting glucose level. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Time Frame
Baseline and Week 12
Title
Mean Change From Baseline in Fasting Insulin at Week 12
Description
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the fasting insulin (in micro International units per milliliter [μIU/mL]). Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Time Frame
Baseline and Week 12
Title
Mean Change From Baseline in Homeostasis Model Assessment (HOMA) Index for Nondiabetic Participants at Week 12
Description
Blood samples were collected at specific timepoints for the laboratory evaluation; from the results of fasting glucose and insulin, an insulin resistance (IR) was estimated for the nondiabetic participants using the HOMA-IR computer algorithm. A higher HOMA-IR indicates a higher degree of insulin resistance. Participants who were not considered as having type 2 diabetes mellitus (T2DM) were identified as nondiabetic. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Time Frame
Baseline and Week 12
Title
Mean Change From Baseline in HOMA Index for Diabetic Participants at Week 12
Description
Blood samples were collected at specific timepoints for the laboratory evaluation; from the results of fasting glucose and insulin, an insulin resistance (IR) was estimated for the nondiabetic participants using the HOMA-IR computer algorithm. A higher HOMA-IR indicates a higher degree of insulin resistance. Participants who were considered as having T2DM were identified as diabetic. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Time Frame
Baseline and Week 12
Title
Mean Change From Baseline in Glycated Hemoglobin (HbA1c) in Participants With T2DM at Week 12
Description
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the HbA1c. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Time Frame
Baseline and Week 12
Title
Maximum Plasma Concentration (Cmax) of EDP-305 on Day 1 and Week 12
Description
The Cmax is the maximum observed plasma concentration, which was measured for EDP-305 on Day 1 and Week 12 for the samples collected according to the intensive sampling scheme for the participants in the Pharmacokinetic (PK) Population.
Time Frame
Predose and 2, 6, and 8 hours postdose on Day 1 and on Day 84 (Week 12)
Title
Time to Reach Maximum Plasma Concentration (Tmax) of EDP-305 on Day 1 and at Week 12
Description
The Tmax was measured for EDP-305 on Day 1 and at Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.
Time Frame
Predose and 2, 6, and 8 hours postdose on Day 1 and on Day 84 (Week 12)
Title
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
Description
AUC(last) is defined as the area under the plasma concentration-time curve from time zero to time the last quantifiable concentration, computed using the linear up/log down trapezoidal rule. AUC(last) was computed for EDP-305 on Day 1 and Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.
Time Frame
Predose and 2, 6, and 8 hours postdose on Day 1 and on Day 84 (Week 12)
Title
Cmax of EP-022571 on Day 1 and at Week 12
Description
The Cmax is the maximum observed plasma concentration, which was measured for EP-022571 (a metabolite of EDP-305) on Day 1 and Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.
Time Frame
Predose and 2, 6, and 8 hours postdose on Day 1 and on Day 84 (Week 12)
Title
Tmax of EP-022571 on Day 1 and at Week 12
Description
The Tmax was measured for EP-022571 (a metabolite of EDP-305) on Day 1 and at Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.
Time Frame
Predose and 2, 6, and 8 hours postdose on Day 1 and on Day 84 (Week 12)
Title
AUC(Last) of EP-022571 on Day 1 and at Week 12
Description
AUC(last) is defined as the area under the plasma concentration-time curve from time zero to time the last quantifiable concentration, computed using the linear up/log down trapezoidal rule. AUC(last) was computed for EP-022571 (a metabolite of EDP-305) on Day 1 and Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.
Time Frame
Predose and 2, 6, and 8 hours postdose on Day 1 and on Day 84 (Week 12)
Title
Cmax of EP-022572 on Day 1 and at Week 12
Description
The Cmax is the maximum observed plasma concentration, which was measured for EP-022572 (a metabolite of EDP-305) on Day 1 and Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.
Time Frame
Predose and 2, 6, and 8 hours postdose on Day 1 and on Day 84 (Week 12)
Title
Tmax of EP-022572 on Day 1 and at Week 12
Description
The Tmax was measured for EP-022572 (a metabolite of EDP-305) on Day 1 and at Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.
Time Frame
Predose and 2, 6, and 8 hours postdose on Day 1 and on Day 84 (Week 12)
Title
AUC(Last) of EP-022572 on Day 1 and at Week 12
Description
AUC(last) is defined as the area under the plasma concentration-time curve from time zero to time the last quantifiable concentration, computed using the linear up/log down trapezoidal rule. AUC(last) was computed for EP-022572 (a metabolite of EDP-305) on Day 1 and Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.
Time Frame
Predose and 2, 6, and 8 hours postdose on Day 1 and on Day 84 (Week 12)
Title
Cmax of EP-022679 on Day 1 and at Week 12
Description
The Cmax is the maximum observed plasma concentration, which was measured for EP-022679 (a metabolite of EDP-305) on Day 1 and Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.
Time Frame
Predose and 2, 6, and 8 hours postdose on Day 1 and on Day 84 (Week 12)
Title
Tmax of EP-022679 on Day 1 and at Week 12
Description
The Tmax was measured for EP-022679 (a metabolite of EDP-305) on Day 1 and at Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.
Time Frame
Predose and 2, 6, and 8 hours postdose on Day 1 and on Day 84 (Week 12)
Title
AUC(Last) of EP-022679 on Day 1 and at Week 12
Description
AUC(last) is defined as the area under the plasma concentration-time curve from time zero to time the last quantifiable concentration, computed using the linear up/log down trapezoidal rule. AUC(last) was computed for EP-022679 (a metabolite of EDP-305) on Day 1 and Week 12 for the samples collected according to the intensive sampling scheme for the participants in the PK Population.
Time Frame
Predose and 2, 6, and 8 hours postdose on Day 1 and on Day 84 (Week 12)
Title
Mean Change From Baseline in Body Weight at Week 12
Description
Body weight was measured at specific timepoints for the participants. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Time Frame
Baseline and Week 12
Title
Mean Change From Baseline in Waist to Hip (WTH) Ratio at Week 12
Description
The WTH ratio is calculated as the ratio of waist to hip circumference, which was measured at specific timepoints. Baseline refers to the last non-missing value collected prior to the first dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Time Frame
Baseline and Week 12
Title
Mean Change From Baseline in Fibroblast Growth Factor 19 (FGF19) by Nominal Timepoint (Intensive Pharmacodynamic [PD] Samples) at Week 12
Description
Blood samples were collected according to the intensive sampling scheme at specific timepoints to assess the PD marker: FGF19. Baseline refers to the last non-missing predose value collected prior to the most recent dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Time Frame
Predose and 2, 6, and 8 hours postdose on Day 1 and Day 84 (Week 12)
Title
Mean Change From Baseline in FGF19 by Bin Timepoint (Sparse PD Samples) at Week 12
Description
Blood samples were collected according to the sparse sampling scheme at specific timepoints to assess the PD marker: FGF19. Baseline refers to the last non-missing predose value collected prior to the most recent dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Time Frame
Predose and two samples postdose (first sample between 1 to 3 hours postdose and second sample 1 hour later than fist sample) on Day 1 and Day 84 (Week 12)
Title
Mean Change From Baseline in 7a-Hydroxy-4-Cholestene-3-One (C4) by Nominal Timepoint (Intensive PD Samples) at Week 12
Description
Blood samples were collected according to the intensive sampling scheme at specific timepoints to assess the PD marker: C4. Baseline refers to the last non-missing predose value collected prior to the most recent dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Time Frame
Predose and 2, 6, and 8 hours postdose on Day 1 and Day 84 (Week 12)
Title
Mean Change From Baseline in C4 by Bin Timepoint (Sparse PD Samples) at Week 12
Description
Blood samples were collected according to the sparse sampling scheme at specific timepoints to assess the PD marker: C4. Baseline refers to the last non-missing predose value collected prior to the most recent dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Time Frame
Predose and two samples postdose (first sample between 1 to 3 hours postdose and second sample 1 hour later than fist sample) on Day 1 and Day 84 (Week 12)
Title
Mean Change From Baseline in Bile Acid (BA) by Nominal Timepoint (Intensive PD Samples) at Week 12
Description
Blood samples were collected according to the intensive sampling scheme at specific timepoints to assess the PD marker: BA. Baseline refers to the last non-missing predose value collected prior to the most recent dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Time Frame
Predose and 2, 6, and 8 hours postdose on Day 1 and Day 84 (Week 12)
Title
Mean Change From Baseline in BA by Bin Timepoint (Sparse PD Samples) at Week 12
Description
Blood samples were collected according to the sparse sampling scheme at specific timepoints to assess the PD marker: BA. Baseline refers to the last non-missing predose value collected prior to the most recent dose of study treatment. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Time Frame
Predose and two samples postdose (first sample between 1 to 3 hours postdose and second sample 1 hour later than fist sample) on Day 1 and Day 84 (Week 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie Adda, MD
Organizational Affiliation
Enanta Pharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Radiant Research Incorporated
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Central Arizona Medical Associates
City
Mesa
State/Province
Arizona
ZIP/Postal Code
58206
Country
United States
Facility Name
Mayo Clinic Specialty Building
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Anaheim Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
estudy site - Chula Vista
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Southern California Research Center
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Fresno Clinical Research Center (FCRC)
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
UCSD Altman Clinical and Translational Research Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Clinical Trials Research
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
National Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Catalina Research Institute, LLC
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
Inland Empire Liver Foundation
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
Southern California Transplantation Institute Research Foundation
City
San Clemente
State/Province
California
ZIP/Postal Code
92673
Country
United States
Facility Name
Precision Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
Peak Gastroenterology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Clinical Research Advantage, Inc. / Colorado Springs Family Practice
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
South Denver Gastroenterology,P.C.
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Fleming Island Center for Clinical Research
City
Fleming Island
State/Province
Florida
ZIP/Postal Code
32003
Country
United States
Facility Name
Westside Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Jacksonville Center for Endoscopy - Southside ; Borland Groover Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32226
Country
United States
Facility Name
Precision Clinical Research, LLC.
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Ocean Blue Medical Research Center, Inc
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Homestead Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
Research Associates of South Florida, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Florida Advanced Medical Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Clinical Neuroscience Solutions Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Advanced Gastroenterology Associates, LLC
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Piedmont Atlanta Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Gastrointestinal Specialists Of Georgia
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Feinberg School of Medicine Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Midwest Institute For Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
WestGlen Gastrointestinal Consultants, PA
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66217
Country
United States
Facility Name
Oshsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Digestive Disease Associates, PA
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Kansas City Research Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
AGA Clinical Research Associates, LLC
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
Northwell Health Inc.
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
NYU Langone Medical Center - The Center for Musculoskeletal Care (CMC)
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Carolinas Medical Center Transplant Center/Center for Liver Disease
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Carolinas Center for Liver Disease / Carolinas Health Care System
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Sterling Research Group, Ltd.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pittsburgh Medical Center - Center for Liver Diseases
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University Of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Quality Medical Research, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Texas Clinical Research Institute
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Texas Diabetes & Endocrinology
City
Austin
State/Province
Texas
ZIP/Postal Code
78749
Country
United States
Facility Name
Dallas Diabetes Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
DHAT Research Institute
City
Garland
State/Province
Texas
ZIP/Postal Code
75044
Country
United States
Facility Name
Baylor College of Medicine - Advanced Liver Therapies
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Radiant Research, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Wasatch Peak Family Practice/Radiant Research, Inc
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Radiant Research, Inc.
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Gastroenterology Associates, PC
City
Gainesville
State/Province
Virginia
ZIP/Postal Code
20155
Country
United States
Facility Name
Bon Secours St. Mary's Hospital of Richmond, Inc
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23602
Country
United States
Facility Name
The Gastroenterology Group, PC
City
Reston
State/Province
Virginia
ZIP/Postal Code
20191
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Swedish Medical Center-Swedish Organ Transplant and Liver Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of Washington / Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Mayo Clinic Health System - Franciscan Healthcare
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Aggarwal and Associates Limited
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T OG1
Country
Canada
Facility Name
Toronto Liver Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H3M1
Country
Canada
Facility Name
Clinique de recherche Medpharmgene
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 1H2
Country
Canada
Facility Name
Chronic Viral Illness Service McGill University Health Center/Royal Victoria
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3JI
Country
Canada
Facility Name
Hopital Pitie Salpetriere
City
Paris
ZIP/Postal Code
Cedex 13
Country
France
Facility Name
CHU de Bordeaux - GH Sud - Hoital Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
CHU de Strasbourg - Nouvel Hôspital Civil
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Auckland Clinical Studies Limited
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
Latin Clinical Trial Center
City
San Juan
ZIP/Postal Code
PR 00909
Country
Puerto Rico
Facility Name
Addenbrookes Hospital (AH)-Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation
City
London
State/Province
Greater London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34740705
Citation
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.
Results Reference
derived
Learn more about this trial
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis
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