Clinical trial NCT02591836 (phase 2, status: completed)
Conditions: hypercholesterolemia
ICD codes: E78.01, E78.00, Z83.42
Drugs: gemcabene, atorvastatin, placebo
SMILES: CC(C)(CCCCOCCCCC(C)(C)C(O)=O)C(O)=O, CC(C)C1=C(C(=O)NC2=CC=CC=C2)C(=C(N1CC[C@@H](O)C[C@@H](O)CC(O)=O)C1=CC=C(F)C=C1)C1=CC=CC=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Males and Females

          -  18-70 years old

          -  Received a statin as monotherapy while having a LDL-C >100 mg d/L at initial clinical
             washout visit OR

          -  Received no lipid-altering drugs since the initial clinic washout visit and had a mean
             LDL-C as follows at 2 qualifying visits:

          -  ≥ 130 mg/dL if National Cholesterol Education Program (NCEP) Adult Treatment Panel III
             (ATP III) Coronary Heard Disease (CHD) risk ≥ 10%; OR

          -  ≥ 160 mg/dL if NCEP ATP III CHD risk < 10%

          -  Had variability of 2 qualifying LDL-C <20% (i.e. lowest value/highest value >0.8). An
             additional qualifying visit may have been completed by patients who were washing off
             lipid medication in order to reassess LDL-C variability; and

          -  Had a mean LDL-C < 250 mg/dL at 2 qualifying visits

        Exclusion Criteria:

          -  Women of childbearing potential, pregnant or lactating;

          -  Body Mass Index (BMI) >38kg/m²;

          -  TG >400 mg/dL at Visit B2 or B3

          -  Unexplained creatinine phosphokinase (CPK) > 3 x Upper Limit of Normal (ULN) or those
             with a history of unexplained myopathy (including rhabdomyolysis);

          -  Documented cardiac history of: Myocardial infarction*, severe or unstable angina
             pectoris, coronary angioplasty, coronary artery bypass graft, symptomatic carotid
             artery disease or peripheral artery disease, ventricular arrhythmias, recurrent
             supraventricular tachycardia, abnormal QTC interval (QT corrected > 0.44 sec), heart
             failure or any other major cardiovascular event resulting in hospitalization

          -  Uncontrolled hypertension*

          -  Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (HbA1c >8%) or any
             diabetic patient who takes insulin and/or thiazolidinediones

          -  Renal dysfunction including chronic renal failure or insufficiency, or creatinine >2.0
             mg/dL;

          -  Hepatic dysfunction

          -  Uncontrolled hypothyroidism

          -  Abnormal urinalysis

          -  Currently taking any of the following medications:

          -  Potent CYP3A4 inhibitors including indinavir, nelfinavir, ritonavir, saquinavir,
             amiodarone, cimetidine, clarithromycin, erythromycin, erythromycin, fluoxetine,
             itraconazole, ketoconazole, nefazodone and troleandomycin as well as grapefruit juice;

          -  Thiazolidinediones (Avandia, Actos);

          -  Immunosuppressive agents;

          -  St. John's wort

          -  Taking any of the following lipid-altering medications within 5 weeks prior to
             randomization:

          -  Lipid-regulating drugs: Niacin (crystalline >500mg/day, slow release or time release),
             psyllium preparation such as Metamucil (>2 tablespoons/day), fibrates and derivatives,
             bile cholesterol absorption inhibitors including ezetimibe;

          -  Any supplement containing plan sterols/stanols (i.e. Benecol, beta-sitosterol,
             Cholestatin, Phytoquest, Take Control) or cholestin (i.e. Chinese red yeast, fermented
             on rice; Hong Qu, Hong Chu, Herbvalin, Ruby Monascus, Monascus purpureus rice);

          -  Neomycin (oral);

          -  Adrenocortical steroids*

          -  Sibutramine (Meridia);

          -  Insulin;

          -  Orlistat (Xenical);

          -  Isotretinoin