| Primary | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC] | LS mean percent change from baseline to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group [PUC]. LDL-C level was measured by preparative ultracentrifugation (PUC). | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 84. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 84 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | one placebo tablet once daily Placebo: placebo tablet made to resemble active | | OG001 | Obicetrapib 10 mg | one 10 mg Obicetrapib tablet once daily Obicetrapib: 10 mg Obicetrapib tablet |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000.25± 2.480
- OG001-36.05± 1.769
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | <.0001 | | Least Squares (LS) Means | -36.31 | Standard Error of the Mean | 3.019 | 2-Sided | 95 | -42.22 | -30.39 | | | | | Superiority | | |
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| Secondary | Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins] | LS mean percent change from baseline to Day 180 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group [Martin/Hopkins]. LDL-C value was calculated using the Martin/Hopkins equation unless TG >= 400 mg/dL or LDL-C <= 50 mg/dL; where, LDL-C value was measured directly by preparative ultracentrifugation (PUC). | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 180. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 180 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | one placebo tablet once daily Placebo: placebo tablet made to resemble active | | OG001 | Obicetrapib 10 mg | one 10 mg Obicetrapib tablet once daily Obicetrapib: 10 mg Obicetrapib tablet |
| |
| Secondary | Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC] | LS mean percent change from baseline to Day 365 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group [PUC]. LDL-C level was measured by preparative ultracentrifugation (PUC). | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 365. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 365 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | one placebo tablet once daily Placebo: placebo tablet made to resemble active | | OG001 | Obicetrapib 10 mg | one 10 mg Obicetrapib tablet once daily Obicetrapib: 10 mg Obicetrapib tablet |
| |
| Secondary | Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84 | LS mean percent change from baseline to Day 84 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group. | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 84. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 84 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | one placebo tablet once daily Placebo: placebo tablet made to resemble active | | OG001 | Obicetrapib 10 mg | one 10 mg Obicetrapib tablet once daily Obicetrapib: 10 mg Obicetrapib tablet |
| |
| Secondary | Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180 | LS mean percent change from baseline to Day 180 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 180. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 180 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | one placebo tablet once daily Placebo: placebo tablet made to resemble active | | OG001 | Obicetrapib 10 mg | one 10 mg Obicetrapib tablet once daily Obicetrapib: 10 mg Obicetrapib tablet |
| |
| Secondary | Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 365 | LS mean percent change from baseline to Day 365 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 365. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 365 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | one placebo tablet once daily Placebo: placebo tablet made to resemble active | | OG001 | Obicetrapib 10 mg | one 10 mg Obicetrapib tablet once daily Obicetrapib: 10 mg Obicetrapib tablet |
| |
| Secondary | Percent Change in Non-HDL-C From Baseline to Day 84 | LS mean percent change from baseline to Day 84 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) in obicetrapib group compared to the placebo group | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 84. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 84 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | one placebo tablet once daily Placebo: placebo tablet made to resemble active | | OG001 | Obicetrapib 10 mg | one 10 mg Obicetrapib tablet once daily Obicetrapib: 10 mg Obicetrapib tablet |
| |
| Secondary | Percent Change in Non-HDL-C From Baseline to Day 180 | LS mean percent change from baseline to Day 180 in Non-high-density Lipoprotein Cholesterol (non-HDL-C) in obicetrapib group compared to the placebo group | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 180. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 180 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | one placebo tablet once daily Placebo: placebo tablet made to resemble active | | OG001 | Obicetrapib 10 mg | one 10 mg Obicetrapib tablet once daily Obicetrapib: 10 mg Obicetrapib tablet |
| |
| Secondary | Percent Change in Non-HDL-C From Baseline to Day 365 | LS mean percent change from baseline to Day 365 in Non-high-density Lipoprotein Cholesterol (non-HDL-C) in obicetrapib group compared to the placebo group | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 365. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 365 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | one placebo tablet once daily Placebo: placebo tablet made to resemble active | | OG001 | Obicetrapib 10 mg | one 10 mg Obicetrapib tablet once daily Obicetrapib: 10 mg Obicetrapib tablet |
| |
| Secondary | Percent Change in HDL-C From Baseline to Day 84 | LS mean percent change from baseline to Day 84 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 84. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 84 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | one placebo tablet once daily Placebo: placebo tablet made to resemble active | | OG001 | Obicetrapib 10 mg | one 10 mg Obicetrapib tablet once daily Obicetrapib: 10 mg Obicetrapib tablet |
| |
| Secondary | Percent Change in HDL-C From Baseline to Day 180 | LS mean percent change from baseline to Day 180 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 180. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 180 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | one placebo tablet once daily Placebo: placebo tablet made to resemble active | | OG001 | Obicetrapib 10 mg | one 10 mg Obicetrapib tablet once daily Obicetrapib: 10 mg Obicetrapib tablet |
| |
| Secondary | Percent Change in HDL-C From Baseline to Day 365 | LS mean percent change from baseline to Day 365 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 365. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 365 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | one placebo tablet once daily Placebo: placebo tablet made to resemble active | | OG001 | Obicetrapib 10 mg | one 10 mg Obicetrapib tablet once daily Obicetrapib: 10 mg Obicetrapib tablet |
| |
| Secondary | Percent Change in Lp(a) From Baseline to Day 84 | LS mean percent change from baseline to Day 84 in Lipoprotein (a) [Lp(a)] in obicetrapib group compared to the placebo group | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 84. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 84 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | one placebo tablet once daily Placebo: placebo tablet made to resemble active | | OG001 | Obicetrapib 10 mg | one 10 mg Obicetrapib tablet once daily Obicetrapib: 10 mg Obicetrapib tablet |
| |
| Secondary | Percent Change in Lp(a) From Baseline to Day 365 | LS mean percent change from baseline to Day 365 in Lipoprotein (a) [Lp(a)] in obicetrapib group compared to the placebo group | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 365. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 365 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | one placebo tablet once daily Placebo: placebo tablet made to resemble active | | OG001 | Obicetrapib 10 mg | one 10 mg Obicetrapib tablet once daily Obicetrapib: 10 mg Obicetrapib tablet |
| |
| Secondary | Percent Change in Total Cholesterol From Baseline to Day 84 | LS mean percent change from baseline to Day 84 in Total Cholesterol (TC) in obicetrapib group compared to the placebo group | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 84. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 84 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | one placebo tablet once daily Placebo: placebo tablet made to resemble active | | OG001 | Obicetrapib 10 mg | one 10 mg Obicetrapib tablet once daily Obicetrapib: 10 mg Obicetrapib tablet |
| |
| Secondary | Percent Change in Total Cholesterol From Baseline to Day 180 | LS mean percent change from baseline to Day 180 in Total Cholesterol in obicetrapib group compared to the placebo group | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 180. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 180 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | one placebo tablet once daily Placebo: placebo tablet made to resemble active | | OG001 | Obicetrapib 10 mg | one 10 mg Obicetrapib tablet once daily Obicetrapib: 10 mg Obicetrapib tablet |
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| Secondary | Percent Change in Total Cholesterol From Baseline to Day 365 | LS mean percent change from baseline to Day 365 in Total Cholesterol in obicetrapib group compared to the placebo group | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 365. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 365 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | one placebo tablet once daily Placebo: placebo tablet made to resemble active | | OG001 | Obicetrapib 10 mg | one 10 mg Obicetrapib tablet once daily Obicetrapib: 10 mg Obicetrapib tablet |
| |
| Secondary | Percent Change in Triglycerides From Baseline to Day 84 | LS mean percent change from baseline to Day 84 in Triglycerides in obicetrapib group compared to the placebo group | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 84. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 84 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | one placebo tablet once daily Placebo: placebo tablet made to resemble active | | OG001 | Obicetrapib 10 mg | one 10 mg Obicetrapib tablet once daily Obicetrapib: 10 mg Obicetrapib tablet |
| |
| Secondary | Percent Change in Triglycerides From Baseline to Day 180 | LS mean percent change from baseline to Day 180 in Triglycerides in obicetrapib group compared to the placebo group | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 180. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 180 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | one placebo tablet once daily Placebo: placebo tablet made to resemble active | | OG001 | Obicetrapib 10 mg | one 10 mg Obicetrapib tablet once daily Obicetrapib: 10 mg Obicetrapib tablet |
| |
| Secondary | Precent Change in Triglycerides From Baseline to Day 365 | LS mean percent change from baseline to Day 365 in Triglycerides in obicetrapib group compared to the placebo group | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. 2 participants in the obi arm were randomized but did not receive study drug, therefore the "n" for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 365. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 365 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | one placebo tablet once daily Placebo: placebo tablet made to resemble active | | OG001 | Obicetrapib 10 mg | one 10 mg Obicetrapib tablet once daily Obicetrapib: 10 mg Obicetrapib tablet |
| |