Dyslipidemias, High Cholesterol, Hypercholesterolemia
Conditions
Keywords
obicetrapib, statin, LDL-C, cholesterol, atherosclerosis
Brief summary
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.
Detailed description
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.
Interventions
Sponsors
NewAmsterdam Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
placebo tablet made to resemble active
Intervention model description
Placebo-Controlled, Double-Blind, Randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Understanding of the study procedures, willingness to adhere to the study schedules and diet, and agreement to participate in the study by giving written informed consent prior to Screening procedures * Men or women 18 to 70 years of age, inclusive * Women may be enrolled if all 3 of the following criteria are met: * They are not pregnant; * They are not breastfeeding; and * They do not plan on becoming pregnant during the study * Women of childbearing potential must have a negative urine pregnancy test at the Screening Visit. * Women of childbearing potential must agree to use an effective method of avoiding pregnancy from the Screening Visit to 90 days after the last visit. Men whose partners are of childbearing potential must agree to use an effective method of avoiding pregnancy from the Screening Visit to 90 days after the last visit. * Fasting LDL-C levels \>2.5 mmol/L (\>100 mg/dL) and \<4.5 mmol/L (\<175 mg/dL) and TG levels \<4.5 mmol/L (\<400 mg/dL) (Visit 1) and * Willingness to maintain a stable diet and physical activity level throughout the study
Exclusion criteria
* Body mass index \>= 40 kg/m2 * Participation in another clinical study involving an investigational or marketed drug within 30 days prior to the Screening Visit * Currently taking any lipid-altering therapy * Any clinical manifestation of atherosclerotic CVD or any evidence of ischemic coronary disease present on the 12-lead ECG at the Screening Visit * Diagnosis of type 1 or type 2 diabetes mellitus; or HbA1c \>= 6.5% at the Screening visit if no prior diagnosis of diabetes mellitus * Uncontrolled hypertension ie, sitting systolic blood pressure \>160 mmHg and/or sitting diastolic blood pressure \>90 mmHg taken as the average of triplicate measurements. One retest will be allowed, at which point if the retest result is no longer exclusionary, the participant may be randomized * Active muscle disease or persistent creatine kinase concentration \>3 x the upper limit of normal (ULN). One retest will be allowed after 1 week to verify the result, at which point if the retest result is no longer exclusionary, the participant may be randomized * History of torsades de pointes * Estimated glomerular filtration rate \<60 mL/min calculated using the Chronic Kidney Disease Epidemiology Collaboration equation * Hepatic dysfunction as evidenced by any laboratory abnormality as follows: gamma- glutamyl transferase, alanine aminotransferase, or aspartate aminotransferase \>2 x ULN, or total bilirubin \>1.5 x ULN * Anemia, defined as hemoglobin concentration \<11 g/dL for males and hemoglobin concentration \<9 g/dL for females * History of malignancy within the past 5 years, with the exception of non-melanoma skin cancers * Evidence of any other clinically significant non-cardiac disease or condition that, in the opinion of the Investigator, would preclude participation in the study * Known ezetimibe or CETP inhibitor allergy or intolerance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald] | 8 weeks | Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula |
| Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald] | 8 weeks | Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula |
| 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] | 8 weeks | LS Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula |
| Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC] | 8 weeks | Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) |
| Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC] | 8 weeks | Median percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) |
| 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] | 8 weeks | LS Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo | 8 weeks | Mean percent change in ApoB from baseline to Day 57 |
| Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo | 8 weeks | Median percent change in ApoB from baseline to Day 57 |
| LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo | 8 weeks | LS Mean percent change in ApoB from baseline to Day 57 |
| Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo | 8 weeks | Mean percent change in Apo-B from baseline to Day 57 |
| Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo | 8 weeks | Median percent change in Apo-B from baseline to Day 57 |
| LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo | 8 weeks | LS Mean percent change in Apo-B from baseline to Day 57 |
| 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] | 8 weeks | Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula |
| 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] | 8 weeks | Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula |
| 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] | 8 weeks | LS Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula |
| Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald] | 8 weeks | Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula |
| Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald] | 8 weeks | Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula |
| LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald] | 8 weeks | LS Mean percent change in LDL-C from baseline to Day 57; LDL-C calculated using the Friedewald formula |
| Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald] | 8 weeks | Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula |
| Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald] | 8 weeks | Median percent change in LDL-C from baseline to Day 57; LDL-C calculated using the Friedewald formula |
| LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald] | 8 weeks | LS Mean percent change in LDL-C from baseline to Day 57; LDL-C calculated using the Friedewald formula |
| Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC] | 8 weeks | Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) |
| Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC] | 8 weeks | Median percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) |
| LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC] | 8 weeks | LS Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) |
| Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy | 8 weeks | Mean percent change in ApoB from baseline to Day 57 |
| Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy | 8 weeks | Median percent change in ApoB from baseline to Day 57 |
| LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy | 8 weeks | LS Mean Percent change in ApoB from baseline to Day 57 |
| Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald] | 8 weeks | Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula |
| Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald] | 8 weeks | Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula |
| LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald] | 8 weeks | LS Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula |
| Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC] | 8 weeks | Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) |
| Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC] | 8 weeks | Median percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) |
| LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC] | 8 weeks | LS Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC) |
Countries
Netherlands, United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| Placebo placebo obicetrapib + placebo ezetimibe; once daily
Placebo: tablet | 28 |
| Combination Therapy 5 mg obicetrapib + 10 mg ezetimibe; once daily
Obicetrapib 5mg: tablet
Ezetimibe 10mg: tablet | 27 |
| Obicetrapib Monotherapy 5 mg obicetrapib + placebo ezetimibe; once daily
Obicetrapib 5mg: tablet | 28 |
| Ezetimibe Monotherapy placebo obicetrapib + 10 mg ezetimibe; once daily
Ezetimibe 10mg: tablet | 28 |
| Total | 111 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 | 0 | 1 |
| Overall Study | Failed attempt to draw blood | 1 | 0 | 0 | 0 |
| Overall Study | Left the country | 0 | 0 | 1 | 2 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 |
| Overall Study | Moved away from study site | 0 | 1 | 0 | 0 |
| Overall Study | Randomized in error and did not receive study drug | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Combination Therapy | Obicetrapib Monotherapy | Ezetimibe Monotherapy | Total |
|---|---|---|---|---|---|
| Age, Continuous | 54.5 years STANDARD_DEVIATION 9.81 | 53.5 years STANDARD_DEVIATION 11.43 | 59.1 years STANDARD_DEVIATION 7.5 | 54.4 years STANDARD_DEVIATION 9.55 | 55.4 years STANDARD_DEVIATION 9.78 |
| Baseline Low-Density Lipoprotein Cholesterol (LDL-C) Values | 136.8 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 19.86 | 132.2 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 27.48 | 127.5 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 20.87 | 128.0 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 22.33 | 131.13 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 22.64 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 26 Participants | 27 Participants | 25 Participants | 104 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 4 Participants | 4 Participants | 16 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 22 Participants | 23 Participants | 24 Participants | 93 Participants |
| Sex: Female, Male Female | 16 Participants | 16 Participants | 14 Participants | 14 Participants | 60 Participants |
| Sex: Female, Male Male | 12 Participants | 11 Participants | 14 Participants | 14 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 27 | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 6 / 28 | 9 / 27 | 4 / 28 | 8 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 27 | 0 / 28 | 2 / 28 |
Outcome results
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
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy | 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] | -43.55 percent change from baseline | Standard Error 3.746 |
| Placebo | 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] | 1.37 percent change from baseline | Standard Error 3.604 |
p-value: <0.000195% CI: [-55.2, -34.63]Mixed Models Analysis
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)
Time frame: 8 weeks
Population: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy | 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] | -44.10 percent change from baseline | Standard Error 3.813 |
| Placebo | 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] | -0.78 percent change from baseline | Standard Error 4.012 |
p-value: <0.000195% CI: [-54.29, -32.36]ANCOVA
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
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald] | -45.63 percent change from baseline | Standard Deviation 21.677 |
| Placebo | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald] | -0.17 percent change from baseline | Standard Deviation 12.682 |
p-value: <0.000195% CI: [-55.2, -34.63]Mixed Models Analysis
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)
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC] | -44.38 percent change from baseline | Standard Deviation 20.731 |
| Placebo | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC] | -1.53 percent change from baseline | Standard Deviation 15.105 |
p-value: <0.000195% CI: [-54.29, -32.36]ANCOVA
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
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Combination Therapy | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald] | -51.95 percent change from baseline |
| Placebo | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald] | -1.40 percent change from baseline |
p-value: <0.000195% CI: [-55.2, -34.63]Mixed Models Analysis
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)
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Combination Therapy | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC] | -51.40 percent change from baseline |
| Placebo | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC] | -2.00 percent change from baseline |
p-value: <0.000195% CI: [-54.29, -32.36]ANCOVA
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
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy | LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy | -29.73 percent change from baseline | Standard Error 2.73 |
| Placebo | LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy | -8.92 percent change from baseline | Standard Error 2.675 |
p-value: <0.000195% CI: [-28.39, -13.22]Mixed Models Analysis
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
Time frame: 8 weeks
Population: 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy | LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo | -29.73 percent change from baseline | Standard Error 2.73 |
| Placebo | LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo | -0.11 percent change from baseline | Standard Error 2.626 |
p-value: <0.000195% CI: [-37.12, -22.12]Mixed Models Analysis
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
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy | LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo | -22.46 percent change from baseline | Standard Error 2.675 |
| Placebo | LS Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo | -0.11 percent change from baseline | Standard Error 2.626 |
p-value: <0.000195% CI: [-29.83, -14.88]Mixed Models Analysis
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
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald] | -13.42 percent change from baseline | Standard Error 3.675 |
| Placebo | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald] | 1.37 percent change from baseline | Standard Error 3.604 |
p-value: 0.005195% CI: [-25.03, -4.54]Mixed Models Analysis
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)
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC] | -13.55 percent change from baseline | Standard Error 3.891 |
| Placebo | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC] | -0.78 percent change from baseline | Standard Error 4.012 |
p-value: 0.024595% CI: [-23.86, -1.68]ANCOVA
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
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy | 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] | -43.55 percent change from baseline | Standard Error 3.746 |
| Placebo | 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] | -13.42 percent change from baseline | Standard Error 3.675 |
p-value: <0.000195% CI: [-40.55, -19.71]Mixed Models Analysis
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
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald] | -31.99 percent change from baseline | Standard Error 3.686 |
| Placebo | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald] | -13.42 percent change from baseline | Standard Error 3.675 |
p-value: 0.000595% CI: [-28.88, -8.27]Mixed Models Analysis
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
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald] | -31.99 percent change from baseline | Standard Error 3.686 |
| Placebo | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald] | 1.37 percent change from baseline | Standard Error 3.604 |
p-value: <0.000195% CI: [-43.63, -23.09]Mixed Models Analysis
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)
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC] | -28.98 percent change from baseline | Standard Error 3.802 |
| Placebo | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC] | -0.78 percent change from baseline | Standard Error 4.012 |
p-value: <0.000195% CI: [-39.32, -17.08]ANCOVA
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
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy | Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy | -31.62 percent change from baseline | Standard Deviation 15.521 |
| Placebo | Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy | -8.78 percent change from baseline | Standard Deviation 14.445 |
p-value: <0.000195% CI: [-28.39, -13.22]Mixed Models Analysis
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
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy | Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo | -31.62 percent change from baseline | Standard Deviation 15.521 |
| Placebo | Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo | -1.17 percent change from baseline | Standard Deviation 11.692 |
p-value: <0.000195% CI: [-37.12, -22.12]Mixed Models Analysis
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
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy | Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo | -22.15 percent change from baseline | Standard Deviation 13.356 |
| Placebo | Mean Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo | -1.17 percent change from baseline | Standard Deviation 11.692 |
p-value: <0.000195% CI: [-29.83, -14.88]Mixed Models Analysis
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
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald] | -12.69 percent change from baseline | Standard Deviation 21.316 |
| Placebo | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald] | -0.17 percent change from baseline | Standard Deviation 12.682 |
p-value: 0.005195% CI: [-25.03, -4.54]Mixed Models Analysis
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)
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC] | -13.68 percent change from baseline | Standard Deviation 19.573 |
| Placebo | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC] | -1.53 percent change from baseline | Standard Deviation 15.105 |
p-value: 0.024595% CI: [-23.86, -1.68]ANCOVA
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
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy | 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] | -45.63 percent change from baseline | Standard Deviation 21.677 |
| Placebo | 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] | -12.69 percent change from baseline | Standard Deviation 21.316 |
p-value: <0.000195% CI: [-40.55, -19.71]Mixed Models Analysis
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
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald] | -31.88 percent change from baseline | Standard Deviation 18.86 |
| Placebo | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald] | -12.69 percent change from baseline | Standard Deviation 21.316 |
p-value: 0.000595% CI: [-28.88, -8.27]Mixed Models Analysis
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
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald] | -31.88 percent change from baseline | Standard Deviation 18.86 |
| Placebo | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald] | -0.17 percent change from baseline | Standard Deviation 12.682 |
p-value: <0.000195% CI: [-43.63, -23.09]Mixed Models Analysis
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)
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combination Therapy | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC] | -27.94 percent change from baseline | Standard Deviation 18.914 |
| Placebo | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC] | -1.53 percent change from baseline | Standard Deviation 15.105 |
p-value: <0.000195% CI: [-39.32, -17.08]ANCOVA
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
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Combination Therapy | Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy | -34.75 percent change from baseline |
| Placebo | Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Ezetimibe Monotherapy | -8.90 percent change from baseline |
p-value: <0.000195% CI: [-28.39, -13.22]Mixed Models Analysis
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
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Combination Therapy | Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo | -34.75 percent change from baseline |
| Placebo | Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo | -0.90 percent change from baseline |
p-value: <0.000195% CI: [-37.12, -22.12]Mixed Models Analysis
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
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Combination Therapy | Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo | -23.50 percent change from baseline |
| Placebo | Median Percent Change in Apolipoprotein-B (ApoB) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo | -0.90 percent change from baseline |
p-value: <0.000195% CI: [-29.83, -14.88]Mixed Models Analysis
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
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Combination Therapy | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald] | -14.80 percent change from baseline |
| Placebo | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [Friedewald] | -1.40 percent change from baseline |
p-value: 0.005195% CI: [-25.03, -4.54]Mixed Models Analysis
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)
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Combination Therapy | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC] | -14.90 percent change from baseline |
| Placebo | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Ezetimibe Monotherapy Compared to Placebo [PUC] | -2.00 percent change from baseline |
p-value: 0.024595% CI: [-23.86, -1.68]ANCOVA
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
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Combination Therapy | 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] | -51.95 percent change from baseline |
| Placebo | 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] | -14.80 percent change from baseline |
p-value: <0.000195% CI: [-40.55, -19.71]Mixed Models Analysis
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
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Combination Therapy | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald] | -34.40 percent change from baseline |
| Placebo | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Ezetimibe Monotherapy [Friedewald] | -14.80 percent change from baseline |
p-value: 0.000595% CI: [-28.88, -8.27]Mixed Models Analysis
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
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Combination Therapy | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald] | -34.40 percent change from baseline |
| Placebo | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald] | -1.40 percent change from baseline |
p-value: <0.000195% CI: [-43.63, -23.09]Mixed Models Analysis
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)
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Combination Therapy | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC] | -30.10 percent change from baseline |
| Placebo | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC] | -2.00 percent change from baseline |
p-value: <0.000195% CI: [-39.32, -17.08]ANCOVA