Autopsy report · NCT02704403

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

“Study did not meet the predefined primary surrogate efficacy endpoint, no safety issues identified”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 4 years 7 months before it stopped.
• 2,157 participants enrolled.
• Results were posted on the registry 1 year 5 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Genfit

Sponsor type

Industry

Conditions

Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Interventions

Elafibranor; Placebo

Participants

2,157

Sites

326

Countries

Argentina, Australia, Belgium, Canada, Chile, Colombia, Czechia, Denmark, Finland, France, Germany, Italy and more

Trials that died the same way

• Study to Assess the Efficacy and Safety of LX201 for Prevention of Corneal Allograft Rejection Episodes and Graft Failure in Subjects at Increased Immunological Risk
  “The primary efficacy endpoint was not met” (64% match in meaning)
• Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection
  “Study met predefined futility criteria for efficacy endpoints.” (62% match in meaning)
• A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer
  “early efficacy review by the Independent Data Monitoring Committee indicated it was unlikely to meet its primary efficacy endpoints” (60% match in meaning)
• A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participants With Moderate to Severe Atopic Dermatitis
  “Sponsor decision to early terminate the study based on the pre-defined futility criterion for efficacy. No safety concerns were identified.” (60% match in meaning)
• Study of Tesomet With Open-label Extension in Subjects With Prader-Willi Syndrome
  “Due to financial considerations Sponsor is unable to complete the trial and assess the planned objectives/endpoints. No subjects have been randomized to treatment in the clinical trial and the decision therefore has no safety concern for patients” (59% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.