drugset / Trial / NCT02634151

A 12-Week, Phase 2 Study of Gemcabene in Hypercholesterolemia Patients on Stable Moderate and High-Intensity Statins

NCT02634151

Phase 2 Completed 105 enrolled NeuroBo Pharmaceuticals Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study was to assess the efficacy, safety, and tolerability of multiple doses of gemcabene 600 mg QD compared to placebo in patients with hypercholesterolemia not adequately controlled on high-intensity or moderate-intensity stable statin therapy. Patients with HeFH, ASCVD, or otherwise uncontrolled, may be included with baseline LDL-C value ≥ 100 mg/dL. Subjects were randomized 1:1 to gemcabene 600 mg once daily (QD) or placebo.

Timeline

Start
2016-11
Primary completion
2017-06
Completion
2017-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcabene Small molecule 600 mg Oral

Indications