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

NeuroBo Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia

Treatments: Drug: Placebo; Drug: Gemcabene

Study type: Interventional

Funder types: Industry

Identifiers

NCT02571257

1027-018

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo treatment on stable background statin therapy

Treatment:

Drug: Placebo

Gemcabene 300 mg QD

Experimental group

Description:

Gemcabene (also known as CI-1027) treatment on stable background statin therapy

Treatment:

Drug: Gemcabene

Drug: Gemcabene

Gemcabene 900 mg QD

Experimental group

Description:

Gemcabene (also known as CI-1027) treatment on stable background statin therapy

Treatment:

Drug: Gemcabene

Drug: Gemcabene