This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study in Japanese patients to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to stable statin therapy.
This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to stable statin therapy in Japanese patients. The screening period for this study will take up to 2-weeks. Afterwards, patients will be randomized to placebo, 2.5 mg obicetrapib, 5 mg obicetrapib or 10 mg obicetrapib for an 8-week treatment period. After the treatment period, patients will continue for a 4-week safety follow-up visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
102
tablet
No active ingredient
Nippon Kokan Fukuyama Hospital
Fukuyama, Japan
Nakamura Cardiology and Cardiovascular Surgery Clinic
Itoshima, Japan
Kishiwada Tokushu-Kai Hospital
Osaka, Japan
Kyosokai AMC NISHI-UMEDA Clinic
Osaka, Japan
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C was calculated using the Friedewald equation unless TG≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).
Time frame: 8 Weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
Median percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C was calculated using the Friedewald equation unless TG≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).
Time frame: 8 Weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
LS Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C was calculated using the Friedewald equation unless TG≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).
Time frame: 8 Weeks
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Time frame: 8 Weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC)
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Sakurabashi Watanabe Hospital
Osaka, Japan
Uji Tokushu-Kai Hospital
Osaka, Japan
Sanai Hospital
Saitama, Japan
Shinden Higashi Clinic
Sendai, Japan
Soka-Sugiura Clinic
Sōka, Japan
Sugiura Clinic
Tokyo, Japan
Time frame: 8 Weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Time frame: 8 Weeks
Mean Percent Change in Apolipoprotein B (ApoB)
Mean percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.
Time frame: 8 Weeks
Median Percent Change in Apolipoprotein B (ApoB)
Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.
Time frame: 8 Weeks
LS Mean Percent Change in Apolipoprotein B (ApoB)
Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.
Time frame: 8 Weeks
Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group
Time frame: 8 weeks
Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Median percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group
Time frame: 8 Weeks
LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
LS Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group
Time frame: 8 Weeks
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)
Mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group
Time frame: 8 weeks
Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C)
Median percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group
Time frame: 8 Weeks
LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)
LS Mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group.
Time frame: 8 Weeks