| Primary | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Level From Baseline to Week 12 | Percent change was calculated as (Week 12 LDL-C - Baseline LDL-C) / Baseline LDL-C * 100. Negative values indicate reduction in LDL-C. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded. | Full Analysis Set: all randomized participants who received at least one dose of study treatment. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change (%) | | From first day of treatment up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | AZD0780 1 mg | Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG001 | AZD0780 3 mg | Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG002 | AZD0780 10 mg | Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG003 | AZD0780 30 mg | Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG004 | Placebo | Participants received placebo administered orally once daily for up to 12 weeks |
| | Units | Counts |
|---|
| Participants | - OG00086
- OG00185
- OG00284
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-31.19(-37.06 to -25.32)
- OG001-33.83(-39.78 to -27.88)
- OG002-41.09(-46.92 to -35.25)
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| MMRM with fixed effects for baseline LDL-C, treatment, visit, treatment-by-visit; random intercept for participants. Missing Week 12 LDL-C values handled by the MMRM under MAR. Hierarchical testing (in the order of decreasing dose of study treatment) controls two-sided alpha = 0.05. | Mixed Models Analysis | | < 0.001 | | Mean Difference (Net) | -35.27 | | | 2-Sided | 95 | -43.61 | -26.93 | | | Difference = AZD0780 - Placebo; negative values favor AZD0780. | | Superiority | | |
|
| Secondary | Percent Change From Baseline of Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Percent change was calculated as (Week 12 LDL-C - Baseline LDL-C) / Baseline LDL-C * 100. Negative values indicate reduction in LDL-C. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained. | Full Analysis Set: all randomized participants who received at least one dose of study treatment. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change (%) | | From first day of treatment up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | AZD0780 1 mg | Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG001 | AZD0780 3 mg | Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG002 | AZD0780 10 mg | Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG003 | AZD0780 30 mg | |
|
| Secondary | Percent Change From Baseline of Total Cholesterol at Week 12 | Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded. | Full Analysis Set: all randomized participants who received at least one dose of study treatment. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change (%) | | From first day of treatment up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | AZD0780 1 mg | Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG001 | AZD0780 3 mg | Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG002 | AZD0780 10 mg | Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG003 | AZD0780 30 mg | |
|
| Secondary | Percent Change From Baseline of High-Density Lipoprotein Cholesterol (HDL-C) at Week 12 | Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded. | Full Analysis Set: all randomized participants who received at least one dose of study treatment. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change (%) | | From first day of treatment up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | AZD0780 1 mg | Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG001 | AZD0780 3 mg | Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG002 | AZD0780 10 mg | Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG003 | AZD0780 30 mg |
|
| Secondary | Percent Change From Baseline of Triglycerides at Week 12 | Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded. | Full Analysis Set: all randomized participants who received at least one dose of study treatment. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change (%) | | From first day of treatment up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | AZD0780 1 mg | Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG001 | AZD0780 3 mg | Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG002 | AZD0780 10 mg | Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG003 | AZD0780 30 mg | |
|
| Secondary | Percent Change From Baseline of Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded. | Full Analysis Set: all randomized participants who received at least one dose of study treatment. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change (%) | | From first day of treatment up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | AZD0780 1 mg | Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG001 | AZD0780 3 mg | Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG002 | AZD0780 10 mg | Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG003 | AZD0780 30 mg |
|
| Secondary | Percent Change From Baseline of Very-Low-Density Lipoprotein Cholesterol (VLDL-C) at Week 12 | Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded. | Full Analysis Set: all randomized participants who received at least one dose of study treatment. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change (%) | | From first day of treatment up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | AZD0780 1 mg | Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG001 | AZD0780 3 mg | Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG002 | AZD0780 10 mg | Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG003 | AZD0780 30 mg |
|
| Secondary | Percent Change From Baseline of Apolipoprotein A1 at Week 12 | Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded. | Full Analysis Set: all randomized participants who received at least one dose of study treatment. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change (%) | | From first day of treatment up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | AZD0780 1 mg | Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG001 | AZD0780 3 mg | Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG002 | AZD0780 10 mg | Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG003 | AZD0780 30 mg | |
|
| Secondary | Percent Change From Baseline of Apolipoprotein B at Week 12 | Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Hypothetical estimand: data collected after intercurrent events (ICEs) defined in the CSP excluded. | Full Analysis Set: all randomized participants who received at least one dose of study treatment. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change (%) | | From first day of treatment up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | AZD0780 1 mg | Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG001 | AZD0780 3 mg | Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG002 | AZD0780 10 mg | Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG003 | AZD0780 30 mg | |
|
| Secondary | Percent Change From Baseline of Total Cholesterol at Week 12 | Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained. | Full Analysis Set: all randomized participants who received at least one dose of study treatment. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change (%) | | From first day of treatment up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | AZD0780 1 mg | Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG001 | AZD0780 3 mg | Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG002 | AZD0780 10 mg | Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG003 | AZD0780 30 mg | |
|
| Secondary | Percent Change From Baseline of High-Density Lipoprotein Cholesterol (HDL-C) at Week 12 | Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained. | Full Analysis Set: all randomized participants who received at least one dose of study treatment. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change (%) | | From first day of treatment up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | AZD0780 1 mg | Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG001 | AZD0780 3 mg | Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG002 | AZD0780 10 mg | Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG003 | AZD0780 30 mg | |
|
| Secondary | Percent Change From Baseline of Triglycerides at Week 12 | Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained. | Full Analysis Set: all randomized participants who received at least one dose of study treatment. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change (%) | | From first day of treatment up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | AZD0780 1 mg | Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG001 | AZD0780 3 mg | Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG002 | AZD0780 10 mg | Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG003 | AZD0780 30 mg | |
|
| Secondary | Percent Change From Baseline of Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained. | Full Analysis Set: all randomized participants who received at least one dose of study treatment. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change (%) | | From first day of treatment up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | AZD0780 1 mg | Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG001 | AZD0780 3 mg | Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG002 | AZD0780 10 mg | Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG003 | AZD0780 30 mg |
|
| Secondary | Percent Change From Baseline of Very-Low-Density Lipoprotein Cholesterol (VLDL-C) at Week 12 | Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained. | Full Analysis Set: all randomized participants who received at least one dose of study treatment. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change (%) | | From first day of treatment up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | AZD0780 1 mg | Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG001 | AZD0780 3 mg | Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG002 | AZD0780 10 mg | Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG003 | AZD0780 30 mg |
|
| Secondary | Percent Change From Baseline of Apolipoprotein A1 at Week 12 | Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained. | Full Analysis Set: all randomized participants who received at least one dose of study treatment. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change (%) | | From first day of treatment up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | AZD0780 1 mg | Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG001 | AZD0780 3 mg | Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG002 | AZD0780 10 mg | Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG003 | AZD0780 30 mg | |
|
| Secondary | Percent Change From Baseline of Apolipoprotein B at Week 12 | Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Treatment policy estimand: data collected after ICEs defined in the CSP retained. | Full Analysis Set: all randomized participants who received at least one dose of study treatment. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent Change (%) | | From first day of treatment up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | AZD0780 1 mg | Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG001 | AZD0780 3 mg | Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG002 | AZD0780 10 mg | Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG003 | AZD0780 30 mg | |
|
| Secondary | Percent Change From Baseline of Lipoprotein-a at Week 12 | Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Descriptive statistics only. | Full Analysis Set: all randomized participants who received at least one dose of study treatment. For this outcome, only participants with both baseline and week 12 values were included in the analysis. | Posted | | Median | Full Range | Percent Change (%) | | From first day of treatment up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | AZD0780 1 mg | Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG001 | AZD0780 3 mg | Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG002 | AZD0780 10 mg | Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG003 | AZD0780 30 mg | |
|
| Secondary | Percent Change From Baseline of Remnant Cholesterol at Week 12 | Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Descriptive statistics only. | Full Analysis Set: all randomized participants who received at least one dose of study treatment. For this outcome, only participants with both baseline and week 12 values were included in the analysis. | Posted | | Median | Full Range | Percent Change (%) | | From first day of treatment up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | AZD0780 1 mg | Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG001 | AZD0780 3 mg | Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG002 | AZD0780 10 mg | Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG003 | AZD0780 30 mg | |
|
| Secondary | Percent Change From Baseline of High Sensitivity C-reactive Protein (hsCRP) at Week 12 | Percent change was calculated as (Week 12 value - Baseline value) / Baseline value * 100. Negative values indicate reduction in lipid parameter. Baseline is the last non-missing value prior to first administration of study treatment. Descriptive statistics only. | Full Analysis Set: all randomized participants who received at least one dose of study treatment. For this outcome, only participants with both baseline and week 12 values were included in the analysis. | Posted | | Median | Full Range | Percent Change (%) | | From first day of treatment up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | AZD0780 1 mg | Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG001 | AZD0780 3 mg | Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG002 | AZD0780 10 mg | Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG003 | AZD0780 30 mg |
|
| Secondary | AZD0780 Plasma Concentrations Summarized by Sampling Timepoint | Geometric mean plasma concentration; LLOQ = 0.01 umol/L; BLQ values are handled as Not Quantified (NQ) | PK Analysis Set: all participants who received at least one dose of study treatment and who had evaluable PK data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | umol/L | | From week 1 up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | AZD0780 1 mg | Participants received 1 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG001 | AZD0780 3 mg | Participants received 3 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG002 | AZD0780 10 mg | Participants received 10 mg of AZD0780 administered orally once daily for up to 12 weeks | | OG003 | AZD0780 30 mg | Participants received 30 mg of AZD0780 administered orally once daily for up to 12 weeks |
| |