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A 12-Week, Phase 2 Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy, Safety and Tolerability of Gemcabene in Subjects With Hypercholesterolemia Not Adequately Controlled on High-Intensity or Moderate-Intensity Stable Statin Therapy

Trial Profile

A 12-Week, Phase 2 Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy, Safety and Tolerability of Gemcabene in Subjects With Hypercholesterolemia Not Adequately Controlled on High-Intensity or Moderate-Intensity Stable Statin Therapy

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 ROYAL-1
  • Sponsors Gemphire Therapeutics

Most Recent Events

  • 13 Nov 2017 According to a Gemphire Therapeutics media release, company presented the data at the American Heart Associations (AHA) Scientific Sessions in Anaheim, California on November 2017 showing that gemcabene significantly reduces atherogenic remnant lipoprotein and LDL-C as add-on to statins in a cardiometabolic population.
  • 13 Nov 2017 Results published in the Gemphire Therapeutics Media Release.
  • 11 Nov 2017 Trial design and other study details presented at the 90th Annual Scientific Sessions of the American Heart Association.

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