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

Study Overview
=================
Brief 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

Official Title
-----------------
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

Conditions
-----------------
Hypercholesterolemia, Hypertriglyceridemia

Intervention / Treatment
-----------------
* Drug: Gemcabene 150 mg
* Drug: Gemcabene 300 mg
* Drug: Gemcabene 600 mg
* Drug: Gemcabene 900 mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or naturally postmenopausal or surgically menopausal women 18 to 80 years of age Baseline HDL-C <35 mg/dL (0.9 mmol/L) Exclusion Criteria: Creatine phosphokinase (CPK) >3 × the upper limit of normal (ULN) Body Mass Index (BMI) >35 kg/m2 Uncontrolled Hypertension >95 mm Hg 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) Uncontrolled hypothyroidism (TSH >1.5 × 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 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcabene 150 mg<br>Gemcabene 150 mg once daily (QD) | Drug: Gemcabene 150 mg<br>* Blinded capsules and tablets, 150 mg, once daily, 84 days<br>|
| Experimental: Gemcabene 300 mg<br>Gemcabene 300 mg once daily (QD) | Drug: Gemcabene 300 mg<br>* Blinded capsules and tablets, 300 mg, once daily, 84 days<br>|
| Experimental: Gemcabene 600 mg<br>Gemcabene 600 mg once daily (QD) | Drug: Gemcabene 600 mg<br>* Blinded capsules and tablets, 600 mg, once daily, 84 days<br>|
| Experimental: Gemcabene 900 mg<br>Gemcabene 900 mg once daily (QD) | Drug: Gemcabene 900 mg<br>* Blinded capsules and tablets, 900 mg, once daily, 84 days<br>|
| Placebo Comparator: Placebo<br>Placebo once daily (QD) | Drug: Placebo<br>* Blinded capsule and tablets, once daily, 84 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDL-C - percent change from baseline |  | 84 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma lipids (eg, LDL-C, VLDL-C, TG)- percent change from baseline |  | 84 days | 
| Adverse Events |  | 84 days | 
| Clinical Laboratory - hematology, chemistry, urinalysis | Clinical Laboratory Abnormalities | 84 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lipid Regulator, TG