NCT02634151

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

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: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: NeuroBo Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypercholesteremia

Interventions

Type	Name	Description
DRUG	Gemcabene	Two 300 mg tablets and 1 placebo tablet administered orally, once daily for 12 weeks.
DRUG	Placebo	Three placebo tablets administered orally once daily for 12 weeks.

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-06-01
• Completion: 2017-08-01
• First posted: 2015-12-17
• Last updated: 2020-06-25
• Results posted: 2020-06-25

Locations

24 sites across 1 country: United States