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

Conditions

• Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Elafibranor — DRUG
• Placebo — DRUG

Study Details

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.

Key Dates

Start date

Mar 31, 2016

Status verified

Feb 2022

Primary completion

Oct 28, 2020

Completion

Oct 28, 2020

Study Design

Enrollment

2,157 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 120 mg Elafibranor
  Coated tablets dosed at 120mg Elafibranor; oral administration; one tablet per day before breakfast with a glass of water
• Placebo Comparator: Placebo
  Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water

Primary Outcome Measure

Number of Elafibranor-treated Participants Relative to Placebo Achieving Resolution of Nonalcoholic Steatohepatitis Without Worsening of Fibrosis [ Time Frame: Measurement at 72 weeks ]

Locations (153)

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