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A Randomized, Double-blind Study to Assess the Safety and Efficacy of EDP-305 in Subjects With Liver-biopsy Proven NASH

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04378010
Recruitment Status : Recruiting
First Posted : May 7, 2020
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
Enanta Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE May 4, 2020
First Posted Date  ICMJE May 7, 2020
Last Update Posted Date August 7, 2020
Actual Study Start Date  ICMJE January 27, 2020
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
Proportion of subjects who achieve ≥1 stage improvement in fibrosis without worsening of steatohepatitis and/or resolution of steatohepatitis and no worsening of liver fibrosis as determined by liver biopsy [ Time Frame: Measurement at Week 72 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
Safety as assessed by adverse events [ Time Frame: Up to 72 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized, Double-blind Study to Assess the Safety and Efficacy of EDP-305 in Subjects With Liver-biopsy Proven NASH
Official Title  ICMJE A Phase 2b Randomized, Double Blind, Placebo-Controlled, Multicenter Study Evaluating Safety and Efficacy of EDP-305 in Subjects With Liver Biopsy Proven Non-Alcoholic Steatohepatitis (NASH) (ARGON-2)
Brief Summary A randomized, double-blind study to assess the safety and efficacy of EDP-305 in subjects with liver-biopsy proven Non-Alcoholic Steatohepatitis (NASH)
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 1.5 mg
    Tablet
  • Drug: EDP-305 2 mg
    Tablet
  • Drug: Placebo
    Tablet
Study Arms  ICMJE
  • Experimental: EDP-305 1.5 mg
    Once a day orally for 72 weeks
    Intervention: Drug: EDP-305 1.5 mg
  • Experimental: EDP-305 2 mg
    Once a day orally for 72 weeks
    Intervention: Drug: EDP-305 2 mg
  • Placebo Comparator: Placebo
    Once a day orally for 72 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 4, 2020)
336
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Informed consent documentation signed and dated by the subject.
  • Male and female subjects, of all ethnic origins, between the ages of 18 and 75 years, inclusive.
  • Subjects of all ethnic origins should have a Body Mass Index (BMI) > 25 kg/m2 and ≥45 except for Asian subjects who qualify for the study with BMI > 23kg/m2.
  • Histological evidence of definite NASH based on NASH Clinical Research Network (CRN) criteria obtained from assessment of a liver biopsy by the central histopathologist. The biopsy may be obtained either 1) during the Screening window or 2) within 6 months prior to the Screening visit.
  • NAFLD Activity Score (NAS) of 4 or greater with a score of at least 1 in each component of the NAS (steatosis scored 0-3, lobular inflammation scored 0-3, ballooning scored 0-2).
  • Fibrosis stage 2 or 3 using the NASH CRN Histologic Scoring System.
  • Subjects must have Screening laboratory values for Hepatitis B surface antigen (HBsAg), anti-HCV antibodies and HCV RNA, and Human Immunodeficiency Virus (HIV) 1 and 2 antibodies (Ab) as seronegative. [Note: subjects previously infected by chronic hepatitis C and treated with direct acting antivirals (DAAs) with sustained virologic response (SVR) for at least 3 years will be allowed.]
  • A woman of childbearing potential who is sexually active with a male must agree to use two effective methods of contraception from the date of Screening until 30 days after the last dose of study drug.
  • A male subject who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after the last dose of study drug.
  • 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 as indicated below:

    • Total white blood cells (WBC) <3000 cells/mm3
    • Absolute neutrophil count (ANC) <1500 cells/mm3
    • Platelet count <140,000/mm3
    • International Normalized Ratio, INR >1.2 (unless due to use of anticoagulants)
    • Estimated glomerular filtration rate (eGFR) < 60 mL/min according to the Modification of Diet in Renal Disease (MDRD) equation
    • AST ≥5× ULN
    • ALT ≥5× ULN
    • ALP ≥ 2x ULN
    • Total bilirubin > 1.5 times ULN during Screening. [Note: Patients with Gilbert's syndrome will be allowed following review by the Medical Monitor if they have a known history of Gilbert's syndrome with a normal direct bilirubin value and normal reticulocyte count.]
  • Pregnant or nursing females.
  • MELD: Model for End-stage Liver Disease score >12.
  • Clinical or laboratory evidence of known chronic liver disease such as alcoholic liver disease, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC).
  • History of acute liver complications due to gallstones (e.g., acute cholecystitis or acute biliary obstruction) unless the subject has had a cholecytectomy (more than 3 months prior to screening).
  • History of liver transplant, or current placement on a liver transplant list.
  • Hepatorenal syndrome (type I or II).
  • Prior variceal hemorrhage, uncontrolled encephalopathy, liver cirrhosis Child-Pugh Class A, B, and C, esophageal varices, or refractory ascites within the previous 6 months of Screening and/or histological presence of liver cirrhosis.
  • Prior or planned ileal resection, or prior or planned bariatric surgery. [Note: Subjects who have undergone gastric surgeries that do not affect drug absorption (e.g., gastric band or gastric sleeve procedures) will be allowed if they are stable for at least 1 year prior to Screening. Gastrectomy or Roux-en-Y bypass will be allowed if stable for at least 3 years prior to Screening.]
  • Subjects with clinically or otherwise documented cardiovascular or cerebrovascular disease including clinically significant anomalies of rhythm or pattern of ECG, that in the judgement of the Principal Investigator (PI) could affect the safety of the subject or their ability to comply with the study requirements.
  • HbA1c ≥ 9.5% within 60 days prior to Day 1.
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: Enanta Pharmaceuticals, Inc 617 607 0705 nadda@enanta.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04378010
Other Study ID Numbers  ICMJE EDP 305-102
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 Not Provided
Responsible Party Enanta Pharmaceuticals
Study Sponsor  ICMJE Enanta Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Enanta Pharmaceuticals, Inc Enanta Pharmaceuticals Inc.
PRS Account Enanta Pharmaceuticals
Verification Date July 2020

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