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

NCT03421431 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: EDP 305-101
• Study Type: interventional
• Target: 134
• Locations: 6 countries
• Sites: 82

Brief Summary

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

Conditions

Non-Alcoholic Steatohepatitis

Keywords

NASH; Non-Alcoholic Steatohepatitis (NASH)

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 12

Secondary Outcomes (35)

• 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

  Baseline and Week 12

• Mean Change From Baseline in Aspartate Aminotransferase to Platelet Ratio Index (APRI) at Week 12

  Baseline and Week 12

• Mean Change From Baseline in Triglycerides (TG) at Week 12

  Baseline and Week 12

• Mean Change From Baseline in Total Cholesterol at Week 12

  Baseline and Week 12

• Mean Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12

  Baseline and Week 12

Study Arms (3)

EDP-305 Dose 1

EXPERIMENTAL

Subjects will take 2 tablets once a day orally for 12 weeks

Drug: EDP-305 Dose 1

EDP-305 Dose 2

EXPERIMENTAL

Subjects will take 2 tablets once a day orally for 12 weeks

Drug: EDP-305 Dose 2

Placebo

PLACEBO COMPARATOR

Subjects will take 2 tablets once a day orally for 12 weeks

Drug: Placebo

Interventions

EDP-305 Dose 1 DRUG

Two tablets daily for 12 weeks

EDP-305 Dose 1

EDP-305 Dose 2 DRUG

Two tablets daily for 12 weeks

EDP-305 Dose 2

Placebo DRUG

Two tablets daily for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead
• ICON Clinical Research: collaborator
• Triangle Biostatistics, LLC: collaborator

Study Sites (82)

Radiant Research Incorporated

Chandler, Arizona, 85224, United States

Location

Central Arizona Medical Associates

Mesa, Arizona, 58206, United States

Location

Mayo Clinic Specialty Building

Phoenix, Arizona, 85054, United States

Location

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

estudy site - Chula Vista

Chula Vista, California, 91911, United States

Location

Southern California Research Center

Coronado, California, 92118, United States

Location

Fresno Clinical Research Center (FCRC)

Fresno, California, 93720, United States

Location

UCSD Altman Clinical and Translational Research Institute

La Jolla, California, 92037, United States

Location

Clinical Trials Research

Lincoln, California, 95648, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

National Research Institute

Los Angeles, California, 90057, United States

Location

Catalina Research Institute, LLC

Montclair, California, 91763, United States

Location

Inland Empire Liver Foundation

Rialto, California, 92377, United States

Location

Southern California Transplantation Institute Research Foundation

San Clemente, California, 92673, United States

Location

Precision Research Institute

San Diego, California, 92114, United States

Location

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907, United States

Location

Clinical Research Advantage, Inc. / Colorado Springs Family Practice

Colorado Springs, Colorado, 80909, United States

Location

South Denver Gastroenterology,P.C.

Englewood, Colorado, 80113, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

Fleming Island Center for Clinical Research

Fleming Island, Florida, 32003, United States

Location

Westside Center for Clinical Research

Jacksonville, Florida, 32205, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Jacksonville Center for Endoscopy - Southside ; Borland Groover Clinic

Jacksonville, Florida, 32226, United States

Location

Precision Clinical Research, LLC.

Lauderdale Lakes, Florida, 33319, United States

Location

Homestead Medical Research

Miami, Florida, 33030, United States

Location

Research Associates of South Florida, LLC

Miami, Florida, 33134, United States

Location

Florida Advanced Medical Research, Inc.

Miami, Florida, 33144, United States

Location

Ocean Blue Medical Research Center, Inc

Miami Springs, Florida, 33166, United States

Location

Clinical Neuroscience Solutions Inc.

Orlando, Florida, 32801, United States

Location

Advanced Gastroenterology Associates, LLC

Palm Harbor, Florida, 34684, United States

Location

Piedmont Atlanta Hospital

Atlanta, Georgia, 30309, United States

Location

Gastrointestinal Specialists Of Georgia

Marietta, Georgia, 30060, United States

Location

Feinberg School of Medicine Northwestern University

Chicago, Illinois, 60611, United States

Location

Midwest Institute For Clinical Research

Indianapolis, Indiana, 46260, United States

Location

WestGlen Gastrointestinal Consultants, PA

Shawnee Mission, Kansas, 66217, United States

Location

Oshsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Digestive Disease Associates, PA

Catonsville, Maryland, 21228, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Kansas City Research Institute

Kansas City, Missouri, 64131, United States

Location

Saint Louis University

St Louis, Missouri, 63104, United States

Location

AGA Clinical Research Associates, LLC

Egg Harbor, New Jersey, 08234, United States

Location

Northwell Health Inc.

Manhasset, New York, 11030, United States

Location

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

New York, New York, 10016, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Carolinas Medical Center Transplant Center/Center for Liver Disease

Charlotte, North Carolina, 28204, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Carolinas Center for Liver Disease / Carolinas Health Care System

Huntersville, North Carolina, 28078, United States

Location

Sterling Research Group, Ltd.

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pittsburgh Medical Center - Center for Liver Diseases

Pittsburgh, Pennsylvania, 15213, United States

Location

University Of Tennessee Health Science Center

Memphis, Tennessee, 38104, United States

Location

Quality Medical Research, PLLC

Nashville, Tennessee, 37211, United States

Location

Texas Clinical Research Institute

Arlington, Texas, 76012, United States

Location

Texas Diabetes & Endocrinology

Austin, Texas, 78749, United States

Location

Dallas Diabetes Research Center

Dallas, Texas, 75230, United States

Location

DHAT Research Institute

Garland, Texas, 75044, United States

Location

Baylor College of Medicine - Advanced Liver Therapies

Houston, Texas, 77030, United States

Location

Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Radiant Research, Inc.

San Antonio, Texas, 78229, United States

Location

Wasatch Peak Family Practice/Radiant Research, Inc

Layton, Utah, 84041, United States

Location

Radiant Research, Inc.

Murray, Utah, 84123, United States

Location

Gastroenterology Associates, PC

Gainesville, Virginia, 20155, United States

Location

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

Newport News, Virginia, 23602, United States

Location

The Gastroenterology Group, PC

Reston, Virginia, 20191, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Swedish Medical Center-Swedish Organ Transplant and Liver Center

Seattle, Washington, 98104, United States

Location

University of Washington / Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Mayo Clinic Health System - Franciscan Healthcare

La Crosse, Wisconsin, 54601, United States

Location

Aggarwal and Associates Limited

Brampton, Ontario, L6T OG1, Canada

Location

Toronto Liver Centre

Toronto, Ontario, M6H3M1, Canada

Location

Clinique de recherche Medpharmgene

Montreal, Quebec, H2K 1H2, Canada

Location

Chronic Viral Illness Service McGill University Health Center/Royal Victoria

Montreal, Quebec, H4A 3JI, Canada

Location

Hopital Pitie Salpetriere

Paris, Cedex 13, France

Location

CHU de Bordeaux - GH Sud - Hoital Haut Leveque

Pessac, 33604, France

Location

CHU de Strasbourg - Nouvel Hôspital Civil

Strasbourg, 67000, France

Location

Auckland Clinical Studies Limited

Auckland, 1010, New Zealand

Location

Latin Clinical Trial Center

San Juan, PR 00909, Puerto Rico

Location

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

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

King's College Hospital NHS Foundation

London, Greater London, SE5 9RS, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34740705 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Kristin Sanderson
• Organization: Enanta Pharmaceuticals

ksanderson@enanta.com

617-607-0775

Study Officials

• Nathalie Adda, MD

  Enanta Pharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 5, 2018
• Study Start: April 25, 2018
• Primary Completion: June 14, 2019
• Study Completion: July 10, 2019
• Last Updated: September 16, 2021
• Results First Posted: September 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); GB (3); FR (3); NZ (1); US (70); CA (4)