Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients on Stable Statin Therapy

Phase 2

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: Placebo; Drug: Gemcabene

• Registration Number: NCT02571257
• Lead Sponsor: NeuroBo Pharmaceuticals Inc.

Brief Summary

The purpose of this study is to evaluate the effect of gemcabene on LDL-C and other lipid parameters in hypercholesterolemic patients on a stable dose of a statin.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-08
• Primary Completion: 2002-04
• Study Completion: 2002-04
• Study First Submitted: 2015-10-05
• Study First Submitted QC: 2015-10-06
• Study First Posted: 2015-10-08
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-08
• Last Update Posted: 2020-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Males and Females
• 18 to 65 years of age
• Baseline LDL-C ≥ 130 mg/dL (3.4 mmol/L)

Exclusion Criteria

• If female, postmenopausal or surgically menopausal
• Triglycerides (TG) >400 mg/dL
• Creatine phosphokinase (CPK) >3 × the upper limit of normal (ULN)
• Body Mass Index (BMI) >35 kg/m2
• Uncontrolled diabetes mellitus (HbA1c >10%)
• Renal dysfunction (blood urea nitrogen [BUN] or creatinine >2 × ULN)
• Hepatic dysfunction (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >2 × ULN)
• Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or any other major cardiovascular event resulting in hospitalization in previous month

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo treatment on stable background statin therapy
Gemcabene 300 mg QD	Gemcabene	Gemcabene (also known as CI-1027) treatment on stable background statin therapy
Gemcabene 900 mg QD	Gemcabene	Gemcabene (also known as CI-1027) treatment on stable background statin therapy

Primary Outcome Measures

Name	Time	Method
LDL-C - percent change from baseline at Week 8	56 days

Secondary Outcome Measures

Name	Time	Method
Clinical Laboratory	56 days
Plasma lipid levels - percent change from baseline at Week 8	56 days	apolipoprotein B (apoB), total cholesterol (TC), C reactive protein (CRP), triglyceride (TG), very low density lipoprotein (VLDL-C), high density lipoprotein (HDL-C)
Adverse Events	56 days