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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Dyslipidemia

Intervention / Treatment
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* Drug: JTT-302
* Drug: JTT-302
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>JTT-302, 200 mg | Drug: JTT-302<br>* JTT-302, 100 mg tablets, 200 mg dose, oral, 30 minutes after the start of the morning meal<br>|
| Experimental: 2<br>JTT-302, 400 mg | Drug: JTT-302<br>* JTT-302, 100 mg tablets, 400 mg dose, oral, 30 minutes after the start of the morning meal<br>|
| Placebo Comparator: 3<br>Matching placebo tablets | Drug: Placebo<br>* Matching placebo tablets, oral, 30 minutes after the start of the morning meal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from baseline in HDL-C at Week 4 |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change and change from baseline at week 4 in lipid parameters |  | 4 weeks | 
| Evaluate the safety profile of JTT-302 when administered for 4 weeks |  | 4 weeks |