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 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy.
Detailed description
This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy. The screening period for this study will take up to 2-weeks. Afterwards patients will be randomized to placebo, 5 mg obicetrapib or 10 mg obicetrapib for an 8-week treatment period. After the treatment period, patients will continue for a 4-week safety follow-up and a 15-week PK follow-up.
Interventions
DRUGObicetrapib
tablets
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 75 Years
Healthy volunteers
No
Inclusion criteria
* LDL-C \> 70 mg/dL and TG \< 400 mg/dL, * Treated with a high-intensity statin therapy
Exclusion criteria
* BMI \> 40 kg/m * Significant cardiovascular disease * HbA1c \> 10% * Uncontrolled hypertension * Active muscle disease * GFR \< 60 ml/min * Hepatic dysfunction * Anemia * History of malignancy * Alcohol abuse * Treatment with investigational product * Treatment with PCSK9 * Clinically significant condition * Known CETP inhibitor allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | 8-weeks | Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group.LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC), |
| Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | 8-Weeks | Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. \[Friedewald\] LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC), |
| LS Mean Percent Change Iin Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | 8-Weeks | LS mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. \[Friedewald\] LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC), |
| Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | 8-Weeks | Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC). |
| Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | 8-Weeks | Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC). |
| LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | 8-Weeks | LS Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured directly by preparative ultracentrifugation (PUC). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | 8-weeks | Mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group. |
| Mean Percent Change in Apolipoprotein B (ApoB) | 8-Weeks | Mean percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group. |
| LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | 8-Weeks | LS mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group. |
| Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | 8-Weeks | Median percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group. |
| Median Percent Change in Apolipoprotein B (ApoB) | 8-Week | Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group. |
| LS Mean Percent Change in Apolipoprotein B (ApoB) | 8-Weeks | Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group. |
| Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | 8-weeks | Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group |
| Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | 8-Weeks | Median percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group |
| LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | 8-Weeks | LS Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group |
Countries
United States
Participant flow
Recruitment details
195 participants were screened; out of 195, 120 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Placebo once-daily placebo
Obicetrapib: tablets | 40 |
| Obicetrapib 5 mg once-daily obicetrapib
Obicetrapib: tablets | 40 |
| Obicetrapib 10 mg once-daily obicetrapib
Obicetrapib: tablets | 40 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Obicetrapib 5 mg | Obicetrapib 10 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 61.3 years STANDARD_DEVIATION 8.77 | 61.1 years STANDARD_DEVIATION 8.13 | 62.9 years STANDARD_DEVIATION 8.48 | 61.8 years STANDARD_DEVIATION 8.43 |
| Baseline Low-Density Lipoprotein Cholesterol (LDL-C) Values | 98.6 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 31.09 | 99.2 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 30.95 | 94.2 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 31.14 | 97.33 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 31.06 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 6 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 35 Participants | 34 Participants | 106 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 10 Participants | 5 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 32 Participants | 30 Participants | 30 Participants | 92 Participants |
| Sex: Female, Male Female | 21 Participants | 17 Participants | 15 Participants | 53 Participants |
| Sex: Female, Male Male | 19 Participants | 23 Participants | 25 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 17 / 40 | 15 / 40 | 8 / 40 |
| serious Total, serious adverse events | 2 / 40 | 0 / 40 | 0 / 40 |
Outcome results
Primary
LS Mean Percent Change Iin Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
LS mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. \[Friedewald\] LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC),
Time frame: 8-Weeks
Population: 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 |
|---|---|---|---|
| Placebo | LS Mean Percent Change Iin Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | -5.00 percent change from baseline | Standard Error 3.502 |
| Obicetrapib 5 mg | LS Mean Percent Change Iin Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | -37.97 percent change from baseline | Standard Error 3.491 |
| Obicetrapib 10 mg | LS Mean Percent Change Iin Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | -44.18 percent change from baseline | Standard Error 3.461 |
p-value: <0.000195% CI: [-44.03, -21.9]Mixed Models Analysis
p-value: <0.000195% CI: [-50.21, -28.15]Mixed Models Analysis
Primary
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
LS Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured directly by preparative ultracentrifugation (PUC).
Time frame: 8-Weeks
Population: 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 |
|---|---|---|---|
| Placebo | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | -6.70 percent change from baseline | Standard Error 3.263 |
| Obicetrapib 5 mg | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | -35.65 percent change from baseline | Standard Error 3.305 |
| Obicetrapib 10 mg | LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | -46.77 percent change from baseline | Standard Error 3.225 |
p-value: <0.000195% CI: [-38.14, -19.74]ANCOVA
p-value: <0.000195% CI: [-49.16, -30.97]ANCOVA
Primary
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group.LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC),
Time frame: 8-weeks
Population: 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 |
|---|---|---|---|
| Placebo | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | -5.48 percent change from baseline | Standard Deviation 23.357 |
| Obicetrapib 5 mg | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | -37.97 percent change from baseline | Standard Deviation 27.526 |
| Obicetrapib 10 mg | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | -43.35 percent change from baseline | Standard Deviation 19.369 |
p-value: <0.000195% CI: [-44.03, -21.9]Mixed Models Analysis
p-value: <0.000195% CI: [-50.21, -28.15]Mixed Models Analysis
Primary
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Time frame: 8-Weeks
Population: 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 |
|---|---|---|---|
| Placebo | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | -7.11 percent change from baseline | Standard Deviation 20.773 |
| Obicetrapib 5 mg | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | -35.98 percent change from baseline | Standard Deviation 25.469 |
| Obicetrapib 10 mg | Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | -46.06 percent change from baseline | Standard Deviation 19.393 |
p-value: <0.000195% CI: [-38.14, -19.74]ANCOVA
p-value: <0.000195% CI: [-49.16, -30.97]ANCOVA
Primary
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. \[Friedewald\] LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC),
Time frame: 8-Weeks
Population: 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) |
|---|---|---|
| Placebo | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | 0 percent change from baseline |
| Obicetrapib 5 mg | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | -42.90 percent change from baseline |
| Obicetrapib 10 mg | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald] | -45.65 percent change from baseline |
p-value: <0.000195% CI: [-44.03, -21.9]Mixed Models Analysis
p-value: <0.000195% CI: [-50.21, -28.15]Mixed Models Analysis
Primary
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Time frame: 8-Weeks
Population: 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) |
|---|---|---|
| Placebo | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | -6.50 percent change from baseline |
| Obicetrapib 5 mg | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | -41.45 percent change from baseline |
| Obicetrapib 10 mg | Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC] | -50.75 percent change from baseline |
p-value: <0.000195% CI: [-38.14, -19.74]ANCOVA
p-value: <0.000195% CI: [-49.16, -30.97]ANCOVA
Secondary
LS Mean Percent Change in Apolipoprotein B (ApoB)
Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.
Time frame: 8-Weeks
Population: 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 |
|---|---|---|---|
| Placebo | LS Mean Percent Change in Apolipoprotein B (ApoB) | -4.13 percent change from baseline | Standard Error 2.593 |
| Obicetrapib 5 mg | LS Mean Percent Change in Apolipoprotein B (ApoB) | -22.40 percent change from baseline | Standard Error 2.582 |
| Obicetrapib 10 mg | LS Mean Percent Change in Apolipoprotein B (ApoB) | -28.12 percent change from baseline | Standard Error 2.564 |
p-value: <0.000195% CI: [-25.51, -11.02]Mixed Models Analysis
p-value: <0.000195% CI: [-31.22, -16.76]Mixed Models Analysis
Secondary
LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)
LS mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group.
Time frame: 8-Weeks
Population: 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 |
|---|---|---|---|
| Placebo | LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | -6.98 percent change from baseline | Standard Error 6.62 |
| Obicetrapib 5 mg | LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | 122.29 percent change from baseline | Standard Error 6.585 |
| Obicetrapib 10 mg | LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | 157.35 percent change from baseline | Standard Error 6.538 |
p-value: <0.000195% CI: [110.78, 147.77]Mixed Models Analysis
p-value: <0.000195% CI: [145.9, 182.76]Mixed Models Analysis
Secondary
LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
LS Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group
Time frame: 8-Weeks
Population: 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 |
|---|---|---|---|
| Placebo | LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | -3.83 percent change from baseline | Standard Error 3.191 |
| Obicetrapib 5 mg | LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | -34.37 percent change from baseline | Standard Error 3.179 |
| Obicetrapib 10 mg | LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | -39.86 percent change from baseline | Standard Error 3.153 |
p-value: <0.000195% CI: [-39.46, -21.62]Mixed Models Analysis
p-value: <0.000195% CI: [-44.92, -27.14]Mixed Models Analysis
Secondary
Mean Percent Change in Apolipoprotein B (ApoB)
Mean percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.
Time frame: 8-Weeks
Population: 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 |
|---|---|---|---|
| Placebo | Mean Percent Change in Apolipoprotein B (ApoB) | -4.67 percent change from baseline | Standard Deviation 17.687 |
| Obicetrapib 5 mg | Mean Percent Change in Apolipoprotein B (ApoB) | -22.62 percent change from baseline | Standard Deviation 21.882 |
| Obicetrapib 10 mg | Mean Percent Change in Apolipoprotein B (ApoB) | -27.19 percent change from baseline | Standard Deviation 15.329 |
p-value: <0.000195% CI: [-25.51, -11.02]Mixed Models Analysis
p-value: <0.000195% CI: [-31.22, -16.76]Mixed Models Analysis
Secondary
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)
Mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group.
Time frame: 8-weeks
Population: 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 |
|---|---|---|---|
| Placebo | Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | -6.62 percent change from baseline | Standard Deviation 12.436 |
| Obicetrapib 5 mg | Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | 123.92 percent change from baseline | Standard Deviation 57.671 |
| Obicetrapib 10 mg | Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | 156.41 percent change from baseline | Standard Deviation 52.165 |
p-value: <0.000195% CI: [110.78, 147.77]Mixed Models Analysis
p-value: <0.000195% CI: [145.9, 182.76]Mixed Models Analysis
Secondary
Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group
Time frame: 8-weeks
Population: 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 |
|---|---|---|---|
| Placebo | Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | -4.22 percent change from baseline | Standard Deviation 20.44 |
| Obicetrapib 5 mg | Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | -34.28 percent change from baseline | Standard Deviation 25.623 |
| Obicetrapib 10 mg | Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | -39.25 percent change from baseline | Standard Deviation 17.625 |
p-value: <0.000195% CI: [-39.46, -21.62]Mixed Models Analysis
p-value: <0.000195% CI: [-44.92, -27.14]Mixed Models Analysis
Secondary
Median Percent Change in Apolipoprotein B (ApoB)
Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.
Time frame: 8-Week
Population: 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) |
|---|---|---|
| Placebo | Median Percent Change in Apolipoprotein B (ApoB) | -2.60 percent change from baseline |
| Obicetrapib 5 mg | Median Percent Change in Apolipoprotein B (ApoB) | -24.40 percent change from baseline |
| Obicetrapib 10 mg | Median Percent Change in Apolipoprotein B (ApoB) | -29.75 percent change from baseline |
p-value: <0.000195% CI: [-25.51, -11.02]Mixed Models Analysis
p-value: <0.000195% CI: [-31.22, -16.76]Mixed Models Analysis
Secondary
Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C)
Median percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group.
Time frame: 8-Weeks
Population: 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) |
|---|---|---|
| Placebo | Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | -4.90 percent change from baseline |
| Obicetrapib 5 mg | Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | 135.40 percent change from baseline |
| Obicetrapib 10 mg | Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C) | 164.95 percent change from baseline |
p-value: <0.000195% CI: [110.78, 147.77]Mixed Models Analysis
p-value: <0.000195% CI: [145.9, 182.76]Mixed Models Analysis
Secondary
Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Median percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group
Time frame: 8-Weeks
Population: 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) |
|---|---|---|
| Placebo | Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | -3.50 percent change from baseline |
| Obicetrapib 5 mg | Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | -38.90 percent change from baseline |
| Obicetrapib 10 mg | Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | -44.40 percent change from baseline |
p-value: <0.000195% CI: [-39.46, -21.62]Mixed Models Analysis
p-value: <0.000195% CI: [-44.92, -27.14]Mixed Models Analysis