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This study will be a placebo-controlled, double-blind, randomized, phase 2 study in participants with mild dyslipidemia to evaluate the efficacy, safety, and tolerability of obicetrapib and ezetimibe combination therapy.
This study will be a placebo-controlled, double-blind, randomized, phase 2 study in participants with mild dyslipidemia to evaluate the efficacy, safety, and tolerability of obicetrapib and ezetimibe combination therapy. The screening period for this study will take up to 2 weeks. Following the screening period, eligible patients will be randomized to placebo, 5 mg obicetrapib + 10 mg ezetimibe; 5 mg obicetrapib + placebo ezetimibe; or placebo obicetrapib + 10 mg ezetimibe for an 8 week treatment period. After the treatment period, patients will continue for a 4 week safety follow-up and a 8 week PK follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | placebo obicetrapib + placebo ezetimibe; once daily |
|
| Combination therapy | Experimental | 5 mg obicetrapib + 10 mg ezetimibe; once daily |
|
| Obicetrapib monotherapy | Experimental | 5 mg obicetrapib + placebo ezetimibe; once daily |
|
| Ezetimibe monotherapy | Experimental | placebo obicetrapib + 10 mg ezetimibe; once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obicetrapib 5mg | Drug | tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald] | Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula | 8 weeks |
| Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald] | Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula | 8 weeks |
| LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald] | LS Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula | 8 weeks |
| Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC] | Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) | 8 weeks |
| Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC] | Median percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) | 8 weeks |
| LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC] |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald] | Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula | 8 weeks |
| Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald] |
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Inclusion Criteria:
Exclusion Criteria:
One retest will be allowed, at which point if the retest result is no longer exclusionary, the participant may be randomized
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Research | Lincoln | California | 95648 | United States | ||
| Evanston Premier Healthcare Research LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41190670 | Derived | Pirillo A, Catapano AL. The two faces of cholesteryl ester transfer protein inhibitors. Curr Opin Lipidol. 2025 Dec 1;36(6):318-325. doi: 10.1097/MOL.0000000000001017. Epub 2025 Oct 13. |
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234 participants were screened; out of 234, 112 participants were randomized. One participant in the ezetimibe 10 mg group was randomized in error and did not participate in the study or receive study drug
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet |
| FG001 | Combination Therapy | 5 mg obicetrapib + 10 mg ezetimibe; once daily Obicetrapib 5mg: tablet Ezetimibe 10mg: tablet |
| FG002 | Obicetrapib Monotherapy | 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet |
| FG003 | Ezetimibe Monotherapy | placebo obicetrapib + 10 mg ezetimibe; once daily Ezetimibe 10mg: tablet |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet |
| BG001 | Combination Therapy | 5 mg obicetrapib + 10 mg ezetimibe; once daily Obicetrapib 5mg: tablet Ezetimibe 10mg: tablet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald] | Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Mean | Standard Deviation | percent change from baseline | 8 weeks |
|
From first dose of study drug through Week 16
Safety Population included all participants who received at least 1 dose of any study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | NewAmsterdam Pharma | +1(305) 627-3081 | study.director@newamsterdampharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 14, 2021 | Mar 27, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 24, 2021 | Mar 27, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D006937 | Hypercholesterolemia |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006949 | Hyperlipidemias |
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| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| D000960 | Hypolipidemic Agents |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Placebo-Controlled, Double-Blind, Randomized
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placebo tablet made to resemble active
| Ezetimibe 10mg | Drug | tablet |
|
|
| Placebo | Other | tablet |
|
LS Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) |
| 8 weeks |
Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula |
| 8 weeks |
| LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald] | LS Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula | 8 weeks |
| Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC] | Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) | 8 weeks |
| Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC] | Median percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) | 8 weeks |
| LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC] | LS Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) | 8 weeks |
| Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo | Mean percent change in ApoB from baseline to Day 57 | 8 weeks |
| Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo | Median percent change in ApoB from baseline to Day 57 | 8 weeks |
| LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo | LS Mean percent change in ApoB from baseline to Day 57 | 8 weeks |
| Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo | Mean percent change in Apo-B from baseline to Day 57 | 8 weeks |
| Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo | Median percent change in Apo-B from baseline to Day 57 | 8 weeks |
| LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo | LS Mean percent change in Apo-B from baseline to Day 57 | 8 weeks |
| Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy [Friedewald] | Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula | 8 weeks |
| Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy [Friedewald] | Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula | 8 weeks |
| LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy [Friedewald] | LS Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula | 8 weeks |
| Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald] | Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula | 8 weeks |
| Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald] | Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula | 8 weeks |
| LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald] | LS Mean percent change in LDL-C from baseline to Day 57; LDL-C calculated using the Friedewald formula | 8 weeks |
| Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald] | Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula | 8 weeks |
| Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald] | Median percent change in LDL-C from baseline to Day 57; LDL-C calculated using the Friedewald formula | 8 weeks |
| LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald] | LS Mean percent change in LDL-C from baseline to Day 57; LDL-C calculated using the Friedewald formula | 8 weeks |
| Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC] | Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) | 8 weeks |
| Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC] | Median percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) | 8 weeks |
| LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC] | LS Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) | 8 weeks |
| Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy | Mean percent change in ApoB from baseline to Day 57 | 8 weeks |
| Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy | Median percent change in ApoB from baseline to Day 57 | 8 weeks |
| LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy | LS Mean Percent change in ApoB from baseline to Day 57 | 8 weeks |
| Evanston |
| Illinois |
| 60201 |
| United States |
| Juno Research, LLC - Medical Center Office | Houston | Texas | 77054 | United States |
| Huisartsen Praktijk A.M.N. Zijtregto | Rotterdam | 3037 AN | Netherlands |
| Huisartsen Praktijk van Soerland | Rotterdam | 3067 GJ | Netherlands |
| Medisch Centrum Thomsonplein | The Hague | 2565 KN | Netherlands |
| Huisartsen Praktijk Rambharose | The Hague | 2572 GM | Netherlands |
| Huisartsen Praktijk Broekman | Zwijndrecht | 3333 GZ | Netherlands |
| Dokters van Nederhoven | Zwijndrecht | 3334 SB | Netherlands |
| Withdrawal by Subject |
|
| Failed attempt to draw blood |
|
| Left the country |
|
| Randomized in error and did not receive study drug |
|
| Lost to Follow-up |
|
| Moved away from study site |
|
| BG002 | Obicetrapib Monotherapy | 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet |
| BG003 | Ezetimibe Monotherapy | placebo obicetrapib + 10 mg ezetimibe; once daily Ezetimibe 10mg: tablet |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Baseline Low-Density Lipoprotein Cholesterol (LDL-C) Values | Baseline LDL-C is defined as the last measurement prior to the first dose of study drug. LDL-C was calculated using the Friedewald Formula. | Mean | Standard Deviation | milligrams per deciliter (mg/dL) |
|
| Placebo |
placebo obicetrapib + placebo ezetimibe; once daily Placebo: tablet |
|
|
|
| Primary | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald] | Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Median | Full Range | percent change from baseline | 8 weeks |
|
|
|
|
| Primary | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald] | LS Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Least Squares Mean | Standard Error | percent change from baseline | 8 weeks |
|
|
|
|
| Primary | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC] | Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Mean | Standard Deviation | percent change from baseline | 8 weeks |
|
|
|
|
| Primary | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC] | Median percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Median | Full Range | percent change from baseline | 8 weeks |
|
|
|
|
| Primary | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC] | LS Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment | Posted | Least Squares Mean | Standard Error | percent change from baseline | 8 weeks |
|
|
|
|
| Secondary | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald] | Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Mean | Standard Deviation | percent change from baseline | 8 weeks |
|
|
|
|
| Secondary | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald] | Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Median | Full Range | percent change from baseline | 8 weeks |
|
|
|
|
| Secondary | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald] | LS Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Least Squares Mean | Standard Error | percent change from baseline | 8 weeks |
|
|
|
|
| Secondary | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC] | Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Mean | Standard Deviation | percent change from baseline | 8 weeks |
|
|
|
|
| Secondary | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC] | Median percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Median | Full Range | percent change from baseline | 8 weeks |
|
|
|
|
| Secondary | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC] | LS Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Least Squares Mean | Standard Error | percent change from baseline | 8 weeks |
|
|
|
|
| Secondary | Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo | Mean percent change in ApoB from baseline to Day 57 | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Mean | Standard Deviation | percent change from baseline | 8 weeks |
|
|
|
|
| Secondary | Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo | Median percent change in ApoB from baseline to Day 57 | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Median | Full Range | percent change from baseline | 8 weeks |
|
|
|
|
| Secondary | LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo | LS Mean percent change in ApoB from baseline to Day 57 | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment | Posted | Least Squares Mean | Standard Error | percent change from baseline | 8 weeks |
|
|
|
|
| Secondary | Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo | Mean percent change in Apo-B from baseline to Day 57 | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Mean | Standard Deviation | percent change from baseline | 8 weeks |
|
|
|
|
| Secondary | Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo | Median percent change in Apo-B from baseline to Day 57 | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baselinevalue for LDL-C assessment. | Posted | Median | Full Range | percent change from baseline | 8 weeks |
|
|
|
|
| Secondary | LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo | LS Mean percent change in Apo-B from baseline to Day 57 | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Least Squares Mean | Standard Error | percent change from baseline | 8 weeks |
|
|
|
|
| Secondary | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy [Friedewald] | Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Mean | Standard Deviation | percent change from baseline | 8 weeks |
|
|
|
|
| Secondary | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy [Friedewald] | Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Median | Full Range | percent change from baseline | 8 weeks |
|
|
|
|
| Secondary | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy [Friedewald] | LS Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Least Squares Mean | Standard Error | percent change from baseline | 8 weeks |
|
|
|
|
| Secondary | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald] | Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Mean | Standard Deviation | percent change from baseline | 8 weeks |
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|
|
| Secondary | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald] | Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Median | Full Range | percent change from baseline | 8 weeks |
|
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|
|
| Secondary | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald] | LS Mean percent change in LDL-C from baseline to Day 57; LDL-C calculated using the Friedewald formula | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Least Squares Mean | Standard Error | percent change from baseline | 8 weeks |
|
|
|
|
| Secondary | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald] | Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Mean | Standard Deviation | percent change from baseline | 8 weeks |
|
|
|
|
| Secondary | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald] | Median percent change in LDL-C from baseline to Day 57; LDL-C calculated using the Friedewald formula | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Median | Full Range | percent change from baseline | 8 weeks |
|
|
|
|
| Secondary | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald] | LS Mean percent change in LDL-C from baseline to Day 57; LDL-C calculated using the Friedewald formula | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Least Squares Mean | Standard Error | percent change from baseline | 8 weeks |
|
|
|
|
| Secondary | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC] | Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Mean | Standard Deviation | percent change from baseline | 8 weeks |
|
|
|
|
| Secondary | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC] | Median percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Median | Full Range | percent change from baseline | 8 weeks |
|
|
|
|
| Secondary | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC] | LS Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Least Squares Mean | Standard Error | percent change from baseline | 8 weeks |
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|
|
| Secondary | Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy | Mean percent change in ApoB from baseline to Day 57 | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Mean | Standard Deviation | percent change from baseline | 8 weeks |
|
|
|
|
| Secondary | Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy | Median percent change in ApoB from baseline to Day 57 | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Median | Full Range | percent change from baseline | 8 weeks |
|
|
|
|
| Secondary | LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy | LS Mean Percent change in ApoB from baseline to Day 57 | The study was revised from a 12-week treatment period to an 8-week treatment period in response to the global COVID-19 pandemic. Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment. | Posted | Least Squares Mean | Standard Error | percent change from baseline | 8 weeks |
|
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 6 |
| 28 |
| EG001 | Combination Therapy | 5 mg obicetrapib + 10 mg ezetimibe; once daily Obicetrapib 5mg: tablet Ezetimibe 10mg: tablet | 0 | 27 | 0 | 27 | 9 | 27 |
| EG002 | Obicetrapib Monotherapy | 5 mg obicetrapib + placebo ezetimibe; once daily Obicetrapib 5mg: tablet | 0 | 28 | 0 | 28 | 4 | 28 |
| EG003 | Ezetimibe Monotherapy | placebo obicetrapib + 10 mg ezetimibe; once daily Ezetimibe 10mg: tablet | 0 | 28 | 2 | 28 | 8 | 28 |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA v23.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA v23.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
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| Onychomycosis | Infections and infestations | MedDRA v23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA v23.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
|
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA v23.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA v23.0 | Systematic Assessment |
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| SARS-CoV-2 test positive | Investigations | MedDRA v23.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA v23.0 | Systematic Assessment |
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| Nail fold inflammation | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA v23.0 | Systematic Assessment |
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After the multicenter publication or 12 months after completion of the study, whichever occurs first, Institution may publish the results of its study data. Institution and PI shall provide sponsor with an advance copy of any proposed communications at least 60 days prior and Sponsor shall have 60 days to review. Sponsor may request (a) the deletion of any Confidential Information, (b) reasonable changes, or (c) a delay for an additional period, not to exceed 90 days.
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000963 |
| Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |