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Gemcabene for the Treatment of Pediatric NAFLD: A Phase 2a Study

Trial Profile

Gemcabene for the Treatment of Pediatric NAFLD: A Phase 2a Study

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Gemcabene (Primary)
  • Indications Non-alcoholic fatty liver disease
  • Focus Proof of concept; Therapeutic Use
  • Most Recent Events

    • 15 Mar 2019 According to Gemphire Therapeutics media release, The study enrolled 6 patients and in August 2018, the DSMB halted the trial early due to unanticipated problems in the first three patients and patients will continue to be monitored for 12 months post-final dose.
    • 13 Aug 2018 According to Gemphire Therapeutics media release, this trial was terminated due to unexpected liver problems observed in the patients that underwent 12-week MRI-PDFF imaging scans.
    • 10 Aug 2018 According to Gemphire Therapeutics media release, the Data and Safety Monitoring Board (DSMB) at Emory University School of Medicine overseeing this trial has recommended that the trial be terminated due to unanticipated problems.
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