NCT02585869

Efficacy and Safety of Gemcabene in Patients With Low HDL-C and Either Normal or Elevated Triglycerides

A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Determine the Efficacy and Safety of CI-1027 in Patients With Low HDL-C and Either Normal or Elevated Triglycerides

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: NeuroBo Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of gemcabene on HDL-C, LDL-C, TG, and other lipid levels in patients with low HDL-C

Conditions

• Hypercholesterolemia
• Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	Gemcabene 150 mg	Blinded capsules and tablets, 150 mg, once daily, 84 days
DRUG	Gemcabene 300 mg	Blinded capsules and tablets, 300 mg, once daily, 84 days
DRUG	Gemcabene 600 mg	Blinded capsules and tablets, 600 mg, once daily, 84 days
DRUG	Gemcabene 900 mg	Blinded capsules and tablets, 900 mg, once daily, 84 days
DRUG	Placebo	Blinded capsule and tablets, once daily, 84 days

Timeline

• Start date: 1999-12-01
• Primary completion: 2001-06-01
• Completion: 2001-06-01
• First posted: 2015-10-23
• Last updated: 2020-04-09