Hypercholesterolemia
Conditions
Keywords
LDL-C, Lipid Regulator
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.
Interventions
DRUGGemcabene
1-300 mg tablet, QD, 56 days
DRUGPlacebo
Sponsors
NeuroBo Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL-C - percent change from baseline at Week 8 | 56 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Clinical Laboratory | 56 days | — |
Outcome results
None listed