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A Phase 2 Open-Label, Dose-Finding Study to Assess the Efficacy, Safety, and Tolerability of Gemcabene in Patients With Homozygous Familial Hypercholesterolemia on Stable, Lipid Lowering Therapy (COBALT-1)

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Trial Profile

A Phase 2 Open-Label, Dose-Finding Study to Assess the Efficacy, Safety, and Tolerability of Gemcabene in Patients With Homozygous Familial Hypercholesterolemia on Stable, Lipid Lowering Therapy (COBALT-1)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Gemcabene (Primary)
  • Indications Hypercholesterolaemia
  • Focus Therapeutic Use
  • Acronyms COBALT-1
  • Sponsors Gemphire Therapeutics

    • Most Recent Events

    • 26 Sep 2019 Results evaluating the safety and efficacy of gemcabene as an add on therapy to current lipid lowering regimens in patients with Homozygous Familial Hypercholesterolemia published in the American Journal of Cardiology
    • 25 Sep 2017 The complete data from this study will also be submitted for publication in a peer reviewed journal, according to a Gemphire Therapeutics media release
    • 25 Sep 2017 According to a Gemphire Therapeutics media release, the company is planning to share data from this study with the FDA and EMA in end of Phase 2 meetings.

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