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    Clinical Trial Results:
    Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies (BROOKLYN): A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With a History of HeFH and LDL-C ≥70 mg/dL Who are Not Adequately Controlled by Their Lipid-Modifying Therapies

    Summary
    EudraCT number
    		 2021-005064-22
    Trial protocol
    		 ES   NL   CZ   PL  
    Global end of trial date
    28 May 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jun 2025
    First version publication date
    12 Jun 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    TA-8995-301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05425745
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    NewAmsterdam Pharma BV
    Sponsor organisation address
    Gooimeer 2-35, DC Naarden, Netherlands, 1411
    Public contact
    Study Director, NewAmsterdam Pharma B.V., +31 35 2062971 , study.director@newamsterdampharma.com
    Scientific contact
    Study Director, NewAmsterdam Pharma B.V., +31 35 2062971 , study.director@newamsterdampharma.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Dec 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 May 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    28 May 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the effect of obicetrapib on low-density lipoprotein cholesterol (LDL-C) levels at Day 84.
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki and with all applicable laws and regulations of the locale and country where the study was conducted, and in compliance with Good Clinical Practice Guidelines
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Jul 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 9
    Country: Number of subjects enrolled
    Norway: 9
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    Spain: 50
    Country: Number of subjects enrolled
    Czechia: 45
    Country: Number of subjects enrolled
    United States: 57
    Country: Number of subjects enrolled
    South Africa: 58
    Country: Number of subjects enrolled
    Georgia: 88
    Country: Number of subjects enrolled
    Canada: 32
    Country: Number of subjects enrolled
    United Kingdom: 5
    Worldwide total number of subjects
    354
    EEA total number of subjects
    114
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    254
    From 65 to 84 years
    99
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 513 patients were screened: out of 513, 354 participants were randomized: 236 participants to the obicetrapib 10 mg group and 118 participants to the placebo group

    Pre-assignment
    Screening details
    		 513 patients were screened

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 one placebo tablet once daily; Placebo: placebo tablet made to resemble active
    Arm type
    		 Placebo

    Investigational medicinal product name
    Matching placebo tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily matching placebo tablet

    Arm title
    		 Obicetrapib 10 mg
    Arm description
    		 one 10 mg obicetrapib tablet once daily; Obicetrapib: 10 mg obicetrapib tablet
    Arm type
    		 Experimental

    Investigational medicinal product name
    Obicetrapib 10 mg tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    once daily 10 mg obicetrapib tablet

    Number of subjects in period 1
    		Placebo Obicetrapib 10 mg
    Started
    118
    236
    Completed
    110
    226
    Not completed
    8
    10
         Consent withdrawn by subject
    3
    3
         End of study visit completed by phone
    1
    -
         Subject decision
    1
    -
         Adverse event, non-fatal
    -
    1
         Death
    2
    3
         Lost to follow-up
    1
    2
         Did not return for end of study visit
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 one placebo tablet once daily; Placebo: placebo tablet made to resemble active

    Reporting group title
    Obicetrapib 10 mg
    Reporting group description
    		 one 10 mg obicetrapib tablet once daily; Obicetrapib: 10 mg obicetrapib tablet

    Reporting group values
    		 Placebo Obicetrapib 10 mg Total
    Number of subjects
    		 118 236 354
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 89 165 254
        From 65-84 years
    		 28 71 99
        85 years and over
    		 1 0 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.6 ( 11.06 ) 57 ( 12.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 65 125 190
        Male
    		 53 111 164
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 2 8 10
        Not Hispanic or Latino
    		 114 226 340
        Unknown or Not Reported
    		 2 2 4
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 1 6 7
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 3 3 6
        White
    		 110 219 329
        More than one race
    		 3 4 7
        Unknown or Not Reported
    		 1 4 5
    Baseline Low-Density Lipoprotein Cholesterol (LDL-C)
    Measure Description: Baseline LDL-C is defined as the last measurement prior to the first dose of study drug. LDL-C was measured by Preparative Ultracentrifugation (PUC). Measure Analysis Population Description: 4 participants were missing baseline LDL-C (measured by PUC). 2 pts baseline LDL-C results were not available due to low volume or hemolysis. 2 pts were randomized but did not receive study drug. Therefore, baseline values (baseline defined as the last measurement prior to the first dose of study drug) were not available.
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 119.9 ( 54.47 ) 123.4 ( 49.23 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 one placebo tablet once daily; Placebo: placebo tablet made to resemble active

    Reporting group title
    Obicetrapib 10 mg
    Reporting group description
    		 one 10 mg obicetrapib tablet once daily; Obicetrapib: 10 mg obicetrapib tablet

    Primary: 1. Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC]

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    End point title
    		 1. Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC]
    End point description
    LS mean percent change from baseline to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group [PUC]. LDL-C level was measured by preparative ultracentrifugation (PUC).
    End point type
    Primary
    End point timeframe
    84 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    118
    232
    Units: Percent Change from Baseline
        least squares mean (standard error)
    0.25 ( 2.480 )
    -36.05 ( 1.769 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Obicetrapib 10 mg v Placebo
    Number of subjects included in analysis
    350
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -36.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -42.22
         upper limit
    		 -30.39
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.019

    Secondary: 2. Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins]

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    End point title
    		 2. Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins]
    End point description
    LS mean percent change from baseline to Day 180 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group [Martin/Hopkins]. LDL-C value was calculated using the Martin/Hopkins equation unless TG >= 400 mg/dL or LDL-C <= 50 mg/dL; where, LDL-C value was measured directly by preparative ultracentrifugation (PUC).
    End point type
    Secondary
    End point timeframe
    180 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    118
    234
    Units: Percent Change from Baseline
        least squares mean (standard error)
    5.98 ( 2.925 )
    -31.80 ( 2.054 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib 10 mg
    Number of subjects included in analysis
    352
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -37.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -44.79
         upper limit
    		 -30.78
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.572

    Secondary: 3. Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC]

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    End point title
    		 3. Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC]
    End point description
    LS mean percent change from baseline to Day 365 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group [PUC]. LDL-C level was measured by preparative ultracentrifugation (PUC).
    End point type
    Secondary
    End point timeframe
    365 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    118
    232
    Units: Percent Change from Baseline
        least squares mean (standard error)
    10.30 ( 4.222 )
    -31.14 ( 2.544 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib 10 mg
    Number of subjects included in analysis
    350
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [1]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -41.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -51.14
         upper limit
    		 -31.76
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.938
    Notes
    [1] - The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value<0.05

    Secondary: 4. Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84

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    End point title
    		 4. Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84
    End point description
    LS mean percent change from baseline to Day 84 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group.
    End point type
    Secondary
    End point timeframe
    84 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    118
    234
    Units: Percent Change from Baseline
        least squares mean (standard error)
    2.93 ( 1.758 )
    -21.45 ( 1.219 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib 10 mg
    Number of subjects included in analysis
    352
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [2]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -24.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.58
         upper limit
    		 -20.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.136
    Notes
    [2] - The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value<0.05

    Secondary: 5. Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180

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    End point title
    		 5. Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180
    End point description
    LS mean percent change from baseline to Day 180 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group
    End point type
    Secondary
    End point timeframe
    180 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    118
    234
    Units: Percent Change from Baseline
        least squares mean (standard error)
    6.02 ( 2.127 )
    -18.30 ( 1.472 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib 10 mg
    Number of subjects included in analysis
    352
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [3]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -24.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.38
         upper limit
    		 -19.25
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.583
    Notes
    [3] - The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value<0.05

    Secondary: 6. Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 365

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    End point title
    		 6. Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 365
    End point description
    LS mean percent change from baseline to Day 365 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group
    End point type
    Secondary
    End point timeframe
    365 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    118
    234
    Units: Percent Change from Baseline
        least squares mean (standard error)
    8.15 ( 2.633 )
    -17.62 ( 1.663 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib 10 mg
    Number of subjects included in analysis
    352
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [4]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -25.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -31.88
         upper limit
    		 -19.67
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.114
    Notes
    [4] - The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value<0.05

    Secondary: 7. Percent Change in Non-HDL-C From Baseline to Day 84

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    End point title
    		 7. Percent Change in Non-HDL-C From Baseline to Day 84
    End point description
    LS mean percent change from baseline to Day 84 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) in obicetrapib group compared to the placebo group
    End point type
    Secondary
    End point timeframe
    84 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    118
    234
    Units: Percent Change from Baseline
        least squares mean (standard error)
    2.83 ( 2.188 )
    -31.62 ( 1.520 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Obicetrapib 10 mg v Placebo
    Number of subjects included in analysis
    352
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [5]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -34.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -39.67
         upper limit
    		 -29.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.661
    Notes
    [5] - The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value<0.05

    Secondary: 8. Percent Change in Non-HDL-C From Baseline to Day 180

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    End point title
    		 8. Percent Change in Non-HDL-C From Baseline to Day 180
    End point description
    LS mean percent change from baseline to Day 180 in Non-high-density Lipoprotein Cholesterol (non-HDL-C) in obicetrapib group compared to the placebo group
    End point type
    Secondary
    End point timeframe
    180 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    118
    234
    Units: Percent Change from Baseline
        least squares mean (standard error)
    5.92 ( 2.658 )
    -27.08 ( 1.855 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Obicetrapib 10 mg v Placebo
    Number of subjects included in analysis
    352
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [6]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -39.36
         upper limit
    		 -26.65
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.241
    Notes
    [6] - The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value<0.05

    Secondary: 9. Percent Change in Non-HDL-C From Baseline to Day 365

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    End point title
    		 9. Percent Change in Non-HDL-C From Baseline to Day 365
    End point description
    LS mean percent change from baseline to Day 365 in Non-high-density Lipoprotein Cholesterol (non-HDL-C) in obicetrapib group compared to the placebo group
    End point type
    Secondary
    End point timeframe
    365 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    118
    234
    Units: Percent Change from Baseline
        least squares mean (standard error)
    11.64 ( 3.905 )
    -25.84 ( 2.305 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib 10 mg
    Number of subjects included in analysis
    352
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [7]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -37.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -46.38
         upper limit
    		 -28.58
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.535
    Notes
    [7] - The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value <0.05

    Secondary: 10. Percent Change in HDL-C From Baseline to Day 84

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    End point title
    		 10. Percent Change in HDL-C From Baseline to Day 84
    End point description
    LS mean percent change from baseline to Day 84 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group
    End point type
    Secondary
    End point timeframe
    84 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    118
    234
    Units: Percent Change from Baseline
        least squares mean (standard error)
    1.26 ( 5.078 )
    139.92 ( 3.614 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Obicetrapib 10 mg v Placebo
    Number of subjects included in analysis
    352
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [8]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    138.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 126.42
         upper limit
    		 150.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.244
    Notes
    [8] - The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value <0.05

    Secondary: 11. Percent Change in HDL-C From Baseline to Day 180

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    End point title
    		 11. Percent Change in HDL-C From Baseline to Day 180
    End point description
    LS mean percent change from baseline to Day 180 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group
    End point type
    Secondary
    End point timeframe
    180 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    118
    234
    Units: Percent Change from Baseline
        least squares mean (standard error)
    2.63 ( 5.484 )
    133.83 ( 3.730 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib 10 mg
    Number of subjects included in analysis
    352
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [9]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    131.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 118.27
         upper limit
    		 144.13
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.595
    Notes
    [9] - The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value <0.05

    Secondary: 12. Percent Change in HDL-C From Baseline to Day 365

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    End point title
    		 12. Percent Change in HDL-C From Baseline to Day 365
    End point description
    LS mean percent change from baseline to Day 365 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group
    End point type
    Secondary
    End point timeframe
    365 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    118
    234
    Units: Percent Change from Baseline
        least squares mean (standard error)
    6.28 ( 5.994 )
    127.67 ( 4.222 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib 10 mg
    Number of subjects included in analysis
    352
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [10]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    121.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 107.02
         upper limit
    		 135.76
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.333
    Notes
    [10] - The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value <0.05

    Secondary: 13. Percent Change in Lp(a) From Baseline to Day 84

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    End point title
    		 13. Percent Change in Lp(a) From Baseline to Day 84
    End point description
    LS mean percent change from baseline to Day 84 in Lipoprotein (a) [Lp(a)] in obicetrapib group compared to the placebo group
    End point type
    Secondary
    End point timeframe
    84 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    118
    234
    Units: Percent Change from Baseline
        least squares mean (standard error)
    10.52 ( 9.413 )
    -35.42 ( 4.527 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib 10 mg
    Number of subjects included in analysis
    352
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [11]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -45.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -65.88
         upper limit
    		 -26
    Variability estimate
    Standard error of the mean
    Dispersion value
    10.14
    Notes
    [11] - The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value<0.05

    Secondary: 14. Percent Change in Lp(a) From Baseline to Day 365

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    End point title
    		 14. Percent Change in Lp(a) From Baseline to Day 365
    End point description
    LS mean percent change from baseline to Day 365 in Lipoprotein (a) [Lp(a)] in obicetrapib group compared to the placebo group
    End point type
    Secondary
    End point timeframe
    365 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    118
    234
    Units: Percent Change from Baseline
        least squares mean (standard error)
    24.37 ( 37.111 )
    -29.93 ( 11.224 )
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo v Obicetrapib 10 mg
    Number of subjects included in analysis
    352
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1648 [12]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean
    Point estimate
    -54.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -131.13
         upper limit
    		 22.53
    Variability estimate
    Standard error of the mean
    Dispersion value
    38.924
    Notes
    [12] - The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value<0.05; therefore hierarchical testing was stopped for subsequent secondary endpoints

    Secondary: 15. Percent Change in Total Cholesterol From Baseline to Day 84

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    End point title
    		 15. Percent Change in Total Cholesterol From Baseline to Day 84
    End point description
    LS mean percent change from baseline to Day 84 in Total Cholesterol (TC) in obicetrapib group compared to the placebo group
    End point type
    Secondary
    End point timeframe
    84 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    118
    234
    Units: Percent Change from Baseline
        least squares mean (standard error)
    2.34 ( 1.796 )
    12.09 ( 1.268 )
    No statistical analyses for this end point

    Secondary: 16. Percent Change in Total Cholesterol From Baseline to Day 180

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    End point title
    		 16. Percent Change in Total Cholesterol From Baseline to Day 180
    End point description
    LS mean percent change from baseline to Day 180 in Total Cholesterol in obicetrapib group compared to the placebo group
    End point type
    Secondary
    End point timeframe
    180 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    118
    234
    Units: Percent Change from Baseline
        least squares mean (standard error)
    4.44 ( 2.043 )
    14.43 ( 1.438 )
    No statistical analyses for this end point

    Secondary: 17. Percent Change in Total Cholesterol From Baseline to Day 365

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    End point title
    		 17. Percent Change in Total Cholesterol From Baseline to Day 365
    End point description
    LS mean percent change from baseline to Day 365 in Total Cholesterol in obicetrapib group compared to the placebo group
    End point type
    Secondary
    End point timeframe
    365 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    118
    234
    Units: Percent Change from Baseline
        least squares mean (standard error)
    9.32 ( 2.801 )
    13.92 ( 1.684 )
    No statistical analyses for this end point

    Secondary: 18. Percent Change in Triglycerides From Baseline to Day 84

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    End point title
    		 18. Percent Change in Triglycerides From Baseline to Day 84
    End point description
    LS mean percent change from baseline to Day 84 in Triglycerides in obicetrapib group compared to the placebo group
    End point type
    Secondary
    End point timeframe
    84 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    118
    234
    Units: Percent Change from Baseline
        least squares mean (standard error)
    10.16 ( 4.207 )
    -1.57 ( 2.580 )
    No statistical analyses for this end point

    Secondary: 19. Percent Change in Triglycerides From Baseline to Day 180

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    End point title
    		 19. Percent Change in Triglycerides From Baseline to Day 180
    End point description
    LS mean percent change from baseline to Day 180 in Triglycerides in obicetrapib group compared to the placebo group
    End point type
    Secondary
    End point timeframe
    180 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    118
    234
    Units: Percent Change from Baseline
        least squares mean (standard error)
    12.43 ( 4.178 )
    4.49 ( 2.885 )
    No statistical analyses for this end point

    Secondary: 20. Percent Change in Triglycerides From Baseline to Day 365

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    End point title
    		 20. Percent Change in Triglycerides From Baseline to Day 365
    End point description
    LS mean percent change from baseline to Day 365 in Triglycerides in obicetrapib group compared to the placebo group
    End point type
    Secondary
    End point timeframe
    365 Days
    End point values
    		 Placebo Obicetrapib 10 mg
    Number of subjects analysed
    118
    234
    Units: Percent Change from Baseline
        least squares mean (standard error)
    7.39 ( 5.642 )
    2.27 ( 3.219 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug up to Week 54
    Adverse event reporting additional description
    Safety Population included all participants who received at least 1 dose of any study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 one placebo tablet once daily; Placebo: placebo tablet made to resemble active

    Reporting group title
    Obicetrapib 10 mg
    Reporting group description
    		 one 10 mg Obicetrapib tablet once daily; Obicetrapib: 10 mg Obicetrapib tablet

    Serious adverse events
    		 Placebo Obicetrapib 10 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 118 (6.78%)
    13 / 234 (5.56%)
         number of deaths (all causes)
    2
    3
         number of deaths resulting from adverse events
    2
    3
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 118 (0.00%)
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland adenoma
         subjects affected / exposed
    0 / 118 (0.00%)
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accident
         subjects affected / exposed
    0 / 118 (0.00%)
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Rib fracture
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 234 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Angiopathy
         subjects affected / exposed
    0 / 118 (0.00%)
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Deep vein thrombosis
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 234 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 118 (0.85%)
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    2 / 118 (1.69%)
    0 / 234 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 118 (0.00%)
    2 / 234 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 118 (0.00%)
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 234 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 118 (0.00%)
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 118 (0.00%)
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
    Additional description: From natural causes
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 234 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    0 / 118 (0.00%)
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 234 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal fistula
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 234 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 234 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 118 (0.00%)
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 118 (0.00%)
    2 / 234 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumothorax
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 234 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 118 (0.00%)
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal stenosis
         subjects affected / exposed
    0 / 118 (0.00%)
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Diabetic gangrene
         subjects affected / exposed
    1 / 118 (0.85%)
    0 / 234 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 118 (0.00%)
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 118 (0.00%)
    1 / 234 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo Obicetrapib 10 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    52 / 118 (44.07%)
    95 / 234 (40.60%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    5 / 118 (4.24%)
    3 / 234 (1.28%)
         occurrences all number
    6
    4
    Vascular disorders
    Hypertension
         subjects affected / exposed
    8 / 118 (6.78%)
    14 / 234 (5.98%)
         occurrences all number
    10
    14
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 118 (5.08%)
    7 / 234 (2.99%)
         occurrences all number
    8
    9
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    7 / 118 (5.93%)
    2 / 234 (0.85%)
         occurrences all number
    7
    2
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    8 / 118 (6.78%)
    9 / 234 (3.85%)
         occurrences all number
    9
    10
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 118 (2.54%)
    5 / 234 (2.14%)
         occurrences all number
    3
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 118 (2.54%)
    9 / 234 (3.85%)
         occurrences all number
    4
    9
    Back pain
         subjects affected / exposed
    6 / 118 (5.08%)
    7 / 234 (2.99%)
         occurrences all number
    6
    7
    Myalgia
         subjects affected / exposed
    1 / 118 (0.85%)
    10 / 234 (4.27%)
         occurrences all number
    1
    10
    Pain in extremity
         subjects affected / exposed
    4 / 118 (3.39%)
    6 / 234 (2.56%)
         occurrences all number
    4
    8
    Infections and infestations
    COVID-19
         subjects affected / exposed
    8 / 118 (6.78%)
    15 / 234 (6.41%)
         occurrences all number
    8
    16
    Influenza
         subjects affected / exposed
    7 / 118 (5.93%)
    21 / 234 (8.97%)
         occurrences all number
    7
    22
    Nasopharyngitis
         subjects affected / exposed
    5 / 118 (4.24%)
    15 / 234 (6.41%)
         occurrences all number
    5
    17
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 118 (3.39%)
    12 / 234 (5.13%)
         occurrences all number
    4
    15
    Urinary tract infection
         subjects affected / exposed
    5 / 118 (4.24%)
    7 / 234 (2.99%)
         occurrences all number
    5
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/38705341
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