Gemphire Therapeutics enrolls first patient in ROYAL-1 trial
Gemphire Therapeutics announced enrollment of its first patients in ROYAL-1, a Phase 2b trial designed to investigate gemcabene in the treatment of patients with hypercholesterolemia not adequately controlled on high-intensity or moderate-intensity stable statin therapy. It is designed to enroll a broad patient population, including patients with heterozygous familial hypercholesterolemia and atherosclerotic cardiovascular disease, who have baseline LDL-C, or "bad cholesterol," values greater than or equal to 100 mg/dL. The randomized, placebo-controlled, double-blind Phase 2b trial, "A 12-Week, Phase 2 Study of Gemcabene in Hypercholesterolemia Patients on Stable Moderate and High-Intensity Statins," will enroll up to 104 adult patients at clinical sites in the United States. Patients meeting eligibility requirements are being randomized in a 1:1 ratio to 600mg of gemcabene or placebo. The primary endpoint is the percent change from baseline of LDL-C at 12 weeks. Secondary endpoints include the change from baseline in non-HDL-C, total cholesterol, triglycerides, ApoB, and hsCRP at the 12-week time point. Gemphire currently anticipates the 12-week study to complete enrollment and all patient follow-up visits in the second half of 2017. The company re-issued its initial press release to correct that in the original the phrase "The open-label" should have read "The randomized, placebo-controlled, double-blind".