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

Akros Pharma

Status and phase: Completed; Phase 2

Conditions: Dyslipidemia

Treatments: Drug: Placebo; Drug: JTT-302

Study type: Interventional

Funder types: Industry

Identifiers

NCT00749788

AT302-U-06-003

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

JTT-302, 200 mg

Treatment:

Drug: JTT-302

Drug: JTT-302

2

Experimental group

Description:

JTT-302, 400 mg

Treatment:

Drug: JTT-302

Drug: JTT-302

3

Placebo Comparator group

Description:

Matching placebo tablets

Treatment:

Drug: Placebo