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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03421431
Recruitment Status : Completed
First Posted : February 5, 2018
Last Update Posted : October 10, 2019
Sponsor:
Collaborators:
ICON Clinical Research
Triangle Biostatistics
Information provided by (Responsible Party):
Enanta Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 29, 2018
First Posted Date  ICMJE February 5, 2018
Last Update Posted Date October 10, 2019
Actual Study Start Date  ICMJE April 25, 2018
Actual Primary Completion Date June 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2018)
  • Change from baseline in ALT levels at Week 12 [ Time Frame: Measurement at Week 12 ]
  • Safety as measured by frequency of adverse events (AEs), serious AEs, and AEs leading to discontinuation through Week 12 [ Time Frame: Up to 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03421431 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis
Official Title  ICMJE 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)
Brief Summary A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with Non-Alcoholic Steatohepatitis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Non-Alcoholic Steatohepatitis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: EDP-305 Dose 1
    Subjects will take 2 tablets once a day orally for 12 weeks
    Intervention: Drug: EDP-305 Dose 1
  • Experimental: EDP-305 Dose 2
    Subjects will take 2 tablets once a day orally for 12 weeks
    Intervention: Drug: EDP-305 Dose 2
  • Placebo Comparator: Placebo
    Subjects will take 2 tablets once a day orally for 12 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2019)
134
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2018)
125
Actual Study Completion Date  ICMJE July 10, 2019
Actual Primary Completion Date June 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   New Zealand,   Puerto Rico,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03421431
Other Study ID Numbers  ICMJE EDP 305-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Enanta Pharmaceuticals
Study Sponsor  ICMJE Enanta Pharmaceuticals
Collaborators  ICMJE
  • ICON Clinical Research
  • Triangle Biostatistics
Investigators  ICMJE
Study Director: Nathalie Adda, MD Enanta Pharmaceuticals Inc.
PRS Account Enanta Pharmaceuticals
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP