| Primary | Effect of Fixed-Dose Combination (FDC) Compared to Placebo on LDL-C | LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the placebo group. 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. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 84 Days | | | | ID | Title | Description |
|---|
| OG000 | Fixed Dose Combination | once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule Fixed Dose Combination: tablet; 10 mg obicetrapib and 10 mg ezetimibe fixed does combination Obicetrapib Placebo: tablet; no active ingredient Ezetimibe Placebo: capsule; no active ingredient | | OG001 | Placebo | once-daily placebo tablets (2), placebo capsule Combination Therapy placebo: tablet; no active ingredient Obicetrapib Placebo: tablet; no active ingredient Ezetimibe Placebo: capsule; no active ingredient |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-45.58± 3.465
- OG0013.03± 3.564
|
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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 | -48.61 | Standard Error of the Mean | 4.959 | 2-Sided | 95 | -58.33 | -38.89 | | | | | Superiority | | |
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| Primary | Effect of Fixed Dose Combination (FDC) Compared to Ezetimibe Monotherapy on LDL-C | LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the ezetimibe monotherapy 10 mg group. 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. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 84 Days | | | | ID | Title | Description |
|---|
| OG000 | Fixed Dose Combination | once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule Fixed Dose Combination: tablet; 10 mg obicetrapib and 10 mg ezetimibe fixed does combination Obicetrapib Placebo: tablet; no active ingredient Ezetimibe Placebo: capsule; no active ingredient | | OG001 | Monotherapy Ezetimibe | once-daily ezetimibe 10 mg capsule, 2 placebo tablets Monotherapy ezetimibe: capsule; 10mg ezetimibe Combination Therapy placebo: tablet; no active ingredient Obicetrapib Placebo: tablet; no active ingredient |
|
| Primary | Effect of Fixed Dose Combination (FDC) Compared to Obicetrapib Monotherapy on LDL-C | LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the obicetrapib monotherapy 10 mg group. 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. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 84 Days | | | | ID | Title | Description |
|---|
| OG000 | Fixed Dose Combination | once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule Fixed Dose Combination: tablet; 10 mg obicetrapib and 10mg ezetimibe fixed does combination Obicetrapib Placebo: tablet; no active ingredient Ezetimibe Placebo: capsule; no active ingredient | | OG001 | Monotherapy Obicetrapib | once-daily obicetrapib 10 mg, placebo tablet, placebo capsule Monotherapy obicetrapib: tablet; 10 mg obicetrapib Combination Therapy placebo: tablet; no active ingredient Ezetimibe Placebo: capsule; no active ingredient |
|
| Primary | Effect of Obicetrapib Monotherapy Compared to Placebo on LDL-C | LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg group compared to the placebo group. 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. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 84 Days | | | | ID | Title | Description |
|---|
| OG000 | Monotherapy Obicetrapib | once-daily obicetrapib 10 mg, placebo tablet, placebo capsule Monotherapy obicetrapib: tablet; 10 mg obicetrapib Combination Therapy placebo: tablet; no active ingredient Ezetimibe Placebo: capsule; no active ingredient | | OG001 | Placebo | once-daily placebo tablets (2), placebo capsule Combination Therapy placebo: tablet; no active ingredient Obicetrapib Placebo: tablet; no active ingredient Ezetimibe Placebo: capsule; no active ingredient |
| |
| Secondary | Effect of Fixed Dose Combination (FDC) Compared to Placebo on Non-HDL-C | LS mean percent change in non-high-density lipoprotein cholesterol (Non-HDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) 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. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 84 Days | | | | ID | Title | Description |
|---|
| OG000 | Fixed Dose Combination | once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule Fixed Dose Combination: tablet; 10 mg obicetrapib and 10 mg ezetimibe fixed does combination Obicetrapib Placebo: tablet; no active ingredient Ezetimibe Placebo: capsule; no active ingredient | | OG001 | Placebo | once-daily placebo tablets (2), placebo capsule Combination Therapy placebo: tablet; no active ingredient Obicetrapib Placebo: tablet; no active ingredient Ezetimibe Placebo: capsule; no active ingredient |
| |
| Secondary | Effect of Fixed Dose Combination (FDC) Compared to Placebo on Apolipoprotein B (ApoB) | LS mean percent change in apolipoprotein B (ApoB) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) 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. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 84 Days | | | | ID | Title | Description |
|---|
| OG000 | Fixed Dose Combination | once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule Fixed Dose Combination: tablet; 10 mg obicetrapib and 10 mg ezetimibe fixed does combination Obicetrapib Placebo: tablet; no active ingredient Ezetimibe Placebo: capsule; no active ingredient | | OG001 | Placebo | once-daily placebo tablets (2), placebo capsule Combination Therapy placebo: tablet; no active ingredient Obicetrapib Placebo: tablet; no active ingredient Ezetimibe Placebo: capsule; no active ingredient |
| |
| Secondary | Effect of Obicetrapib Monotherapy Compared to Placebo on Non-HDL-C | LS mean percent change in non-high-density lipoprotein cholesterol (Non-HDL-C) from baseline to Day 84 in the obicetrapib monotherapy 10 mg 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. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 84 Days | | | | ID | Title | Description |
|---|
| OG000 | Monotherapy Obicetrapib | once-daily obicetrapib 10 mg, placebo tablet, placebo capsule Monotherapy obicetrapib: tablet; 10 mg obicetrapib Combination Therapy placebo: tablet; no active ingredient Ezetimibe Placebo: capsule; no active ingredient | | OG001 | Placebo | once-daily placebo tablets (2), placebo capsule Combination Therapy placebo: tablet; no active ingredient Obicetrapib Placebo: tablet; no active ingredient Ezetimibe Placebo: capsule; no active ingredient |
| |
| Secondary | Effect of Obicetrapib Monotherapy Compared to Placebo on Apolipoprotein B (ApoB) | LS mean percent change in apolipoprotein B (ApoB) from baseline to Day 84 in the obicetrapib monotherapy 10 mg 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. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 84 Days | | | | ID | Title | Description |
|---|
| OG000 | Monotherapy Obicetrapib | once-daily obicetrapib 10 mg, placebo tablet, placebo capsule Monotherapy obicetrapib: tablet; 10 mg obicetrapib Combination Therapy placebo: tablet; no active ingredient Ezetimibe Placebo: capsule; no active ingredient | | OG001 | Placebo | once-daily placebo tablets (2), placebo capsule Combination Therapy placebo: tablet; no active ingredient Obicetrapib Placebo: tablet; no active ingredient Ezetimibe Placebo: capsule; no active ingredient |
| |
| Secondary | Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Non-HDL-C | LS mean percent change in non-high-density lipoprotein cholesterol (Non-HDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the ezetimibe monotherapy 10 mg 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. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 84 Days | | | | ID | Title | Description |
|---|
| OG000 | Fixed Dose Combination | once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule Fixed Dose Combination: tablet; 10 mg obicetrapib and 10 mg ezetimibe fixed does combination Obicetrapib Placebo: tablet; no active ingredient Ezetimibe Placebo: capsule; no active ingredient | | OG001 | Monotherapy Ezetimibe | once-daily ezetimibe 10 mg capsule, 2 placebo tablets Monotherapy ezetimibe: capsule; 10 mg ezetimibe Combination Therapy placebo: tablet; no active ingredient Obicetrapib Placebo: tablet; no active ingredient |
|
| Secondary | Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Apolipoprotein B (ApoB) | LS mean percent change in apolipoprotein B (ApoB) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the ezetimibe monotherapy 10 mg 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. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 84 Days | | | | ID | Title | Description |
|---|
| OG000 | Fixed Dose Combination | once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule Fixed Dose Combination: tablet; 10 mg obicetrapib and 10 mg ezetimibe fixed does combination Obicetrapib Placebo: tablet; no active ingredient Ezetimibe Placebo: capsule; no active ingredient | | OG001 | Monotherapy Ezetimibe | once-daily ezetimibe 10 mg capsule, 2 placebo tablets Monotherapy ezetimibe: capsule; 10 mg ezetimibe Combination Therapy placebo: tablet; no active ingredient Obicetrapib Placebo: tablet; no active ingredient |
|
| Secondary | Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Non-HDL-C | LS mean percent change in non-high-density lipoprotein cholesterol (Non-HDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the obicetrapib monotherapy 10mg 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. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 84 Days | | | | ID | Title | Description |
|---|
| OG000 | Fixed Dose Combination | once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule Fixed Dose Combination: tablet; 10 mg obicetrapib and 10 mg ezetimibe fixed does combination Obicetrapib Placebo: tablet; no active ingredient Ezetimibe Placebo: capsule; no active ingredient | | OG001 | Monotherapy Obicetrapib | once-daily obicetrapib 10 mg, placebo tablet, placebo capsule Monotherapy obicetrapib: tablet; 10 mg obicetrapib Combination Therapy placebo: tablet; no active ingredient Ezetimibe Placebo: capsule; no active ingredient |
|
| Secondary | Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Apolipoprotein B (ApoB) | LS mean percent change in Apolipoprotein B (ApoB) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the obicetrapib monotherapy 10 mg 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. Missing values were imputed using a multiple imputation model assuming the data were missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group. | Posted | | Least Squares Mean | Standard Error | percent change from baseline | | 84 Days | | | | ID | Title | Description |
|---|
| OG000 | Fixed Dose Combination | once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule Fixed Dose Combination: tablet; 10 mg obicetrapib and 10 mg ezetimibe fixed does combination Obicetrapib Placebo: tablet; no active ingredient Ezetimibe Placebo: capsule; no active ingredient | | OG001 | Monotherapy Obicetrapib | once-daily obicetrapib 10 mg, placebo tablet, placebo capsule Monotherapy obicetrapib: tablet; 10 mg obicetrapib Combination Therapy placebo: tablet; no active ingredient Ezetimibe Placebo: capsule; no active ingredient |
|