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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

NCT04378010 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2023-05-19

Study results available
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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)

Conditions

  • Non-Alcoholic Steatohepatitis

Interventions

DRUG

EDP-305 1.5 mg

Tablet

DRUG

EDP-305 2 mg

Tablet

DRUG

Placebo

Tablet

Sponsors & Collaborators

  • Enanta Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Enanta Pharmaceuticals, Inc · Enanta Pharmaceuticals, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-27
Primary Completion
2021-10-04
Completion
2021-11-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Canada
  • Germany
  • Puerto Rico
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04378010 on ClinicalTrials.gov