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An Investigator-Initiated Open-Label, Randomized Study of Gemcabene in Adults With Familial Partial Lipodystrophy Disease (FPLD)

Trial Profile

An Investigator-Initiated Open-Label, Randomized Study of Gemcabene in Adults With Familial Partial Lipodystrophy Disease (FPLD)

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 03 Dec 2018

At a glance

  • Drugs Gemcabene (Primary)
  • Indications Lipodystrophy; Non-alcoholic fatty liver disease; Non-alcoholic steatohepatitis
  • Focus Proof of concept; Therapeutic Use
  • Acronyms AZURE-1
  • Most Recent Events

    • 03 Dec 2018 Status changed from recruiting to active, no longer recruiting, according to a Gemphire Therapeutics media release.
    • 08 Nov 2018 According to a Gemphire Therapeutics media release, following the DSMB interim review, additional patients have been enrolled and top-line data, including MRI-PDFF, is expected in Q2 2019.
    • 13 Aug 2018 According to a Gemphire Therapeutics media release, the initial safety review of the first three patients, on a dose of 300 mg/day has not uncovered any safety or tolerability concerns nor was there a change in biomarkers that would indicate concerns about liver function. The principal investigator in the trial intends to closely monitor these patients while waiting for MRI-PDFF scans to be reviewed at an interim time point in the near future before dosing additional patients.
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