Efficacy and Safety Study of JTT-302 in Subjects With Low HDL-C Levels

A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group Study Evaluating the Efficacy and Safety of JTT-302 Administered Daily for Four Weeks in Subjects With Low HDL-C Levels

The purpose of this study is to determine the effect of JTT-302 on the increase of High Density Lipoprotein-Cholesterol (HDL-C) levels when administered daily for four weeks in subjects with low HDL-C levels.

Inclusion Criteria:

• Subjects with a Body Mass Index (BMI)≤ 35 kg/m2
• Subjects with the following lipid parameters at Visit 1 (screening visit) and Visit 3 (diet stabilization period):
• HDL-C ≤ 40 mg/dL (Men) and ≤ 50 mg/dL (Women)
• TG ≤ 500 mg/dL
• LDL-C ≤ 190 mg/dL
• Subjects who are generally healthy as determined by pre-study medical history, physical examination, vital signs and 12-lead ECG

Exclusion Criteria:

• Females who are pregnant or breast-feeding
• AST, ALT or total bilirubin ≥ 2.0 x ULN at Visit 1 (screening visit) or Visit 3 (diet stabilization period)
• Serum thyroid stimulating hormone (TSH) and levothyroxine (T4) outside of the central laboratory reference range at the screening visit
• Medical history of diabetes mellitus or two fasting serum glucose measurements > 126 mg/dL at the screening visit
• Subjects with hypertension, or two blood pressure measurements ≥ 140 mm Hg systolic or ≥ 90 mm Hg diastolic at the screening visit
• History of drug or alcohol abuse within 12 months of the screening visit
• Use of medications defined in the protocol within six-weeks prior to the screening visit and throughout the study
• Use of Cytochrome P450 3A4 inducers or inhibitors, as defined in the protocol within four weeks of the screening visit and throughout the study