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Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)

NCT02704403 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2157

Last updated 2022-03-23

Study results available
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Summary

The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis.

Conditions

  • Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Interventions

DRUG

Elafibranor

DRUG

Placebo

Sponsors & Collaborators

  • Genfit

    lead INDUSTRY

Principal Investigators

  • Carol Addy, MD MMSc · Genfit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2020-10-28
Completion
2020-10-28
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Canada
  • Chile
  • Colombia
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Italy
  • Mexico
  • Netherlands
  • Portugal
  • Puerto Rico
  • Romania
  • Russia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • 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 NCT02704403 on ClinicalTrials.gov