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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00749788

Enrollment

150

Registered

2008-09-09

Start date

2006-12-31

Completion date

2008-02-29

Last updated

2013-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

Brief summary

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.

Interventions

DRUGJTT-302

JTT-302, 100 mg tablets, 200 mg dose, oral, 30 minutes after the start of the morning meal

DRUGPlacebo

Matching placebo tablets, oral, 30 minutes after the start of the morning meal

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Percent change from baseline in HDL-C at Week 4	4 weeks

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026