Atherosclerotic Cardiovascular Disease
Conditions
Brief summary
This study looks at how well a new medicine, NNC0385-0434, works to lower blood cholesterol levels. Participants will either get NNC0385-0434 as a tablet (a potential new medicine), or placebo as a tablet (a dummy medicine that looks like NNC0385-0434 but has no effect on the body), or evolocumab as an injection (a medicine that doctors can already prescribe). Which treatment participants get is decided by chance. If participants get NNC0385-0434 or placebo participants will need to take 1 tablet every morning. If participants get evolocumab participants will need to take 1 injection every 2 weeks. The study will last for about 22 weeks. About 255 people will participate in the study. Participants will have 9 visits to the clinic and 2 phone calls with the study doctor. Some people will be invited to participate in a sub-study and will have 4 extra visits (13 visits in total). Participants will have blood samples taken at all visits to the clinic (except visit 0). At 4 clinic visits, participants will have an electrocardiogram (ECG). This is a test to check your heart. Women can only take part in the study if they are not able to become pregnant.
Interventions
DRUGNNC0385-0434 A 15 mg
15 mg administered as one oral tablet once daily in the morning in a fasting state. The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day. The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces).
DRUGNNC0385-0434 A 40 mg
40 mg administered as one oral tablet once daily in the morning in a fasting state. The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day. The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces).
OTHERPlacebo I A (for NNC0385-0434 A 15 mg)
Placebo administered as 1 tablet once daily in the morning in a fasting state. The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day. The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces). placebo tablets are sized match to the active arm within dose level
100 mg administered as one oral tablet once daily in the morning in a fasting state. The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day. The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces).
OTHERPlacebo I A (for NNC0385-0434 A 40 mg)
Placebo administered as one tablet once daily in the morning in a fasting state. The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day. The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces). placebo tablets are sized match to the active arm within dose level
OTHERPlacebo II A (for NNC0385-0434 A 100 mg)
Placebo administered as one tablet once daily in the morning in a fasting state. The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day. The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces). placebo tablets are sized match to the active arm within dose level
DRUGEvolocumab 140 mg/mL, Repatha®
Every 2 weeks subcutaneous (s.c.) injection of 140 mg into areas of the abdomen, thigh, or upper arm that are not tender, bruised, red, or indurated. Administered using a pre-filled SureClick® autoinjector (single-use). Dose volume: 1 mL
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
The trial will be double-blinded within dose level of oral NNC0385-0434 and size-matched placebo arm. The subcutaneous (s.c.) evolocumab arm will be open label.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or females of non-childbearing potential. * Established atherosclerotic cardiovascular disease (ASCVD) (criteria a) or ASCVD risk (criteria b): 1. Age 40 years or older at the time of signing informed consent and history of ASCVD 2. Age above 50 years at the time of signing informed consent and with ASCVD risk * Serum LDL-C above or equal to 1.8 mmol/L (above or equal to 70 mg/dL) as measured by the central laboratory at screening. * Japanese participants: Serum LDL-C above or equal to 2.6 mmol/L (above or equal to 100 mg/dL) for participants of 40 years of age or older and with a history of coronary heart disease, and serum LDL-C above or equal to 3.1 mmol/L (above or equal to 120 mg/dL) for all other Japanese participants * Participants must be on maximally tolerated dose of statins. * Participants not receiving statin must have documented evidence of intolerance to all doses of at least two different statins.
Exclusion criteria
* Treatment with PCSK9i therapy (alirocumab or evolocumab within 90 days prior to screening) or PCSK9 siRNA therapy (inclisiran within 12 months prior to screening). * Fasting triglyceride above 4.52 mmol/L (above 400 mg/dL) as measured by the central laboratory at screening. * Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening. * Renal impairment with eGFR less than 30 ml/min/1.73 m2 as measured by the central laboratory at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Low-density Lipoprotein (LDL)-Cholesterol | Baseline (week 0), week 12 | Percentage change in LDL-cholesterol (LDL-C) (measured in milligrams per deciliter \[mg/dL\]) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. The in-trial period is defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in High Density Lipoprotein (HDL)-Cholesterol | Baseline (week 0), week 12 | Percentage change in HDL-cholesterol (measured in mg/dL) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. |
| Percentage Change in Very Low Density Lipoprotein (VLDL)-Cholesterol | Baseline (week 0), week 12 | Percentage change in VLDL-cholesterol (measured in mmol/L) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. |
| Percentage Change in Triglycerides | Baseline (week 0), week 12 | Percentage change in triglycerides (measured in mg/dL) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. |
| Percentage Change in Total Cholesterol | Baseline (week 0), week 12 | Percentage change in total cholesterol (measured in millimoles per iliter \[mmol/L\]) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. |
| Percentage Change in Total Apolipoprotein CIII (Apo CIII) | Baseline (week 0), week 12 | Percentage change in Apo CIII (measured in mg/dL) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. |
| Change in Total Lipoprotein(a) (Lp[a]): Ratio to Baseline | Baseline (week 0), week 12 | Change in total Lp(a) (measured in mg/dL) at week 12 is presented as ratio to baseline. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. |
| Number of Treatment-emergent Adverse Events (TEAEs) | From baseline (week 0) to 138 days | An adverse events (AE) is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an investigational medicinal product (IMP), whether or not considered related to the IMP. All presented AEs are TEAEs. TEAEs was the number of AEs recorded during the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. |
| Percentage Change in Total Apolipoprotein B (Apo B) | Baseline (week 0), week 12 | Percentage change in Apo B (measured in mg/dL) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. |
Countries
Belgium, Germany, Greece, Japan, Netherlands, Poland, United States
Participant flow
Recruitment details
The trial was conducted in 7 countries as follows (number of sites that screened participants/ number of sites that randomized participants): Belgium (5/5), Germany (4/4), Greece (6/6), Japan (4/4), Netherlands (6/6), Poland (5/5)and United States (12/12).
Participants by arm
| Arm | Count |
|---|---|
| NNC0385-0434 15 mg Participants received 15 milligrams (mg) NNC0385-0434 (co-formulated with 500 mg salcaprozate sodium \[SNAC\]) tablet orally once daily for 12 weeks. | 53 |
| NNC0385-0434 40 mg Participants received 40 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks. | 53 |
| NNC0385-0434 100 mg Participants received 100 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks. | 53 |
| Placebo Participants received placebo matched to NNC0385-0434 (without SNAC) tablet orally once daily for 12 weeks. | 54 |
| Evolocumab 140 mg Participants received 140 mg evolocumab subcutaneously (s.c.) every 2 weeks for 12 weeks. | 54 |
| Total | 267 |
Baseline characteristics
| Characteristic | NNC0385-0434 15 mg | NNC0385-0434 40 mg | NNC0385-0434 100 mg | Placebo | Evolocumab 140 mg | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 64.1 Years STANDARD_DEVIATION 9.3 | 64.6 Years STANDARD_DEVIATION 8.6 | 65.2 Years STANDARD_DEVIATION 9.2 | 63.1 Years STANDARD_DEVIATION 8.6 | 64.5 Years STANDARD_DEVIATION 9.6 | 64.3 Years STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants | 53 Participants | 53 Participants | 52 Participants | 53 Participants | 264 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 7 Participants | 5 Participants | 5 Participants | 7 Participants | 6 Participants | 30 Participants |
| Race/Ethnicity, Customized Race Black or African American | 0 Participants | 4 Participants | 4 Participants | 1 Participants | 2 Participants | 11 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race White | 46 Participants | 44 Participants | 44 Participants | 46 Participants | 46 Participants | 226 Participants |
| Sex: Female, Male Female | 17 Participants | 17 Participants | 14 Participants | 17 Participants | 17 Participants | 82 Participants |
| Sex: Female, Male Male | 36 Participants | 36 Participants | 39 Participants | 37 Participants | 37 Participants | 185 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 53 | 0 / 53 | 0 / 54 | 0 / 54 |
| other Total, other adverse events | 16 / 53 | 14 / 53 | 19 / 53 | 14 / 54 | 17 / 54 |
| serious Total, serious adverse events | 1 / 53 | 3 / 53 | 1 / 53 | 5 / 54 | 3 / 54 |
Outcome results
Primary
Percentage Change in Low-density Lipoprotein (LDL)-Cholesterol
Percentage change in LDL-cholesterol (LDL-C) (measured in milligrams per deciliter \[mg/dL\]) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. The in-trial period is defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Time frame: Baseline (week 0), week 12
Population: FAS included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NNC0385-0434 15 mg | Percentage Change in Low-density Lipoprotein (LDL)-Cholesterol | -27 Percentage change of LDL cholesterol | Standard Deviation 19 |
| NNC0385-0434 40 mg | Percentage Change in Low-density Lipoprotein (LDL)-Cholesterol | -41 Percentage change of LDL cholesterol | Standard Deviation 37 |
| NNC0385-0434 100 mg | Percentage Change in Low-density Lipoprotein (LDL)-Cholesterol | -55 Percentage change of LDL cholesterol | Standard Deviation 20 |
| Placebo | Percentage Change in Low-density Lipoprotein (LDL)-Cholesterol | 6 Percentage change of LDL cholesterol | Standard Deviation 41 |
| Evolocumab 140 mg | Percentage Change in Low-density Lipoprotein (LDL)-Cholesterol | -59 Percentage change of LDL cholesterol | Standard Deviation 22 |
Comparison: LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.p-value: <0.000195% CI: [-43.02, -20.87]ANCOVA
Comparison: LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.p-value: <0.000195% CI: [-56.04, -33.79]ANCOVA
Comparison: LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.p-value: <0.000195% CI: [-72.94, -50.72]ANCOVA
Comparison: LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.95% CI: [22.16, 44.47]
Comparison: LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.95% CI: [9.21, 31.48]
Comparison: LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.95% CI: [-7.81, 14.68]
Secondary
Change in Total Lipoprotein(a) (Lp[a]): Ratio to Baseline
Change in total Lp(a) (measured in mg/dL) at week 12 is presented as ratio to baseline. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period.
Time frame: Baseline (week 0), week 12
Population: FAS included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| NNC0385-0434 15 mg | Change in Total Lipoprotein(a) (Lp[a]): Ratio to Baseline | 0.79 Ratio of Lipoprotein (a) | Geometric Coefficient of Variation 34.2 |
| NNC0385-0434 40 mg | Change in Total Lipoprotein(a) (Lp[a]): Ratio to Baseline | 0.70 Ratio of Lipoprotein (a) | Geometric Coefficient of Variation 37.6 |
| NNC0385-0434 100 mg | Change in Total Lipoprotein(a) (Lp[a]): Ratio to Baseline | 0.66 Ratio of Lipoprotein (a) | Geometric Coefficient of Variation 40 |
| Placebo | Change in Total Lipoprotein(a) (Lp[a]): Ratio to Baseline | 0.99 Ratio of Lipoprotein (a) | Geometric Coefficient of Variation 31.5 |
| Evolocumab 140 mg | Change in Total Lipoprotein(a) (Lp[a]): Ratio to Baseline | 0.59 Ratio of Lipoprotein (a) | Geometric Coefficient of Variation 43.4 |
Secondary
Number of Treatment-emergent Adverse Events (TEAEs)
An adverse events (AE) is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an investigational medicinal product (IMP), whether or not considered related to the IMP. All presented AEs are TEAEs. TEAEs was the number of AEs recorded during the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period.
Time frame: From baseline (week 0) to 138 days
Population: Safety analysis set (SAS) included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NNC0385-0434 15 mg | Number of Treatment-emergent Adverse Events (TEAEs) | 82 Events |
| NNC0385-0434 40 mg | Number of Treatment-emergent Adverse Events (TEAEs) | 60 Events |
| NNC0385-0434 100 mg | Number of Treatment-emergent Adverse Events (TEAEs) | 65 Events |
| Placebo | Number of Treatment-emergent Adverse Events (TEAEs) | 56 Events |
| Evolocumab 140 mg | Number of Treatment-emergent Adverse Events (TEAEs) | 81 Events |
Secondary
Percentage Change in High Density Lipoprotein (HDL)-Cholesterol
Percentage change in HDL-cholesterol (measured in mg/dL) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period.
Time frame: Baseline (week 0), week 12
Population: FAS included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NNC0385-0434 15 mg | Percentage Change in High Density Lipoprotein (HDL)-Cholesterol | 4 Percentage change of HDL cholesterol | Standard Deviation 13 |
| NNC0385-0434 40 mg | Percentage Change in High Density Lipoprotein (HDL)-Cholesterol | 5 Percentage change of HDL cholesterol | Standard Deviation 16 |
| NNC0385-0434 100 mg | Percentage Change in High Density Lipoprotein (HDL)-Cholesterol | 7 Percentage change of HDL cholesterol | Standard Deviation 16 |
| Placebo | Percentage Change in High Density Lipoprotein (HDL)-Cholesterol | 1 Percentage change of HDL cholesterol | Standard Deviation 14 |
| Evolocumab 140 mg | Percentage Change in High Density Lipoprotein (HDL)-Cholesterol | 5 Percentage change of HDL cholesterol | Standard Deviation 14 |
Secondary
Percentage Change in Total Apolipoprotein B (Apo B)
Percentage change in Apo B (measured in mg/dL) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period.
Time frame: Baseline (week 0), week 12
Population: FAS included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NNC0385-0434 15 mg | Percentage Change in Total Apolipoprotein B (Apo B) | -20 Percentage change of Apo B | Standard Deviation 15 |
| NNC0385-0434 40 mg | Percentage Change in Total Apolipoprotein B (Apo B) | -34 Percentage change of Apo B | Standard Deviation 28 |
| NNC0385-0434 100 mg | Percentage Change in Total Apolipoprotein B (Apo B) | -48 Percentage change of Apo B | Standard Deviation 12 |
| Placebo | Percentage Change in Total Apolipoprotein B (Apo B) | 6 Percentage change of Apo B | Standard Deviation 31 |
| Evolocumab 140 mg | Percentage Change in Total Apolipoprotein B (Apo B) | -52 Percentage change of Apo B | Standard Deviation 17 |
Secondary
Percentage Change in Total Apolipoprotein CIII (Apo CIII)
Percentage change in Apo CIII (measured in mg/dL) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period.
Time frame: Baseline (week 0), week 12
Population: FAS included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NNC0385-0434 15 mg | Percentage Change in Total Apolipoprotein CIII (Apo CIII) | -0 Percentage change of Apo CIII | Standard Deviation 20 |
| NNC0385-0434 40 mg | Percentage Change in Total Apolipoprotein CIII (Apo CIII) | -7 Percentage change of Apo CIII | Standard Deviation 24 |
| NNC0385-0434 100 mg | Percentage Change in Total Apolipoprotein CIII (Apo CIII) | -16 Percentage change of Apo CIII | Standard Deviation 15 |
| Placebo | Percentage Change in Total Apolipoprotein CIII (Apo CIII) | 2 Percentage change of Apo CIII | Standard Deviation 23 |
| Evolocumab 140 mg | Percentage Change in Total Apolipoprotein CIII (Apo CIII) | -15 Percentage change of Apo CIII | Standard Deviation 21 |
Secondary
Percentage Change in Total Cholesterol
Percentage change in total cholesterol (measured in millimoles per iliter \[mmol/L\]) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period.
Time frame: Baseline (week 0), week 12
Population: FAS included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NNC0385-0434 15 mg | Percentage Change in Total Cholesterol | -14 Percentage change of total cholesterol | Standard Deviation 13 |
| NNC0385-0434 40 mg | Percentage Change in Total Cholesterol | -25 Percentage change of total cholesterol | Standard Deviation 27 |
| NNC0385-0434 100 mg | Percentage Change in Total Cholesterol | -33 Percentage change of total cholesterol | Standard Deviation 11 |
| Placebo | Percentage Change in Total Cholesterol | 4 Percentage change of total cholesterol | Standard Deviation 23 |
| Evolocumab 140 mg | Percentage Change in Total Cholesterol | -38 Percentage change of total cholesterol | Standard Deviation 14 |
Secondary
Percentage Change in Triglycerides
Percentage change in triglycerides (measured in mg/dL) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period.
Time frame: Baseline (week 0), week 12
Population: FAS included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NNC0385-0434 15 mg | Percentage Change in Triglycerides | 5 Percentage change of triglycerides | Standard Deviation 27 |
| NNC0385-0434 40 mg | Percentage Change in Triglycerides | -7 Percentage change of triglycerides | Standard Deviation 31 |
| NNC0385-0434 100 mg | Percentage Change in Triglycerides | -16 Percentage change of triglycerides | Standard Deviation 27 |
| Placebo | Percentage Change in Triglycerides | 2 Percentage change of triglycerides | Standard Deviation 41 |
| Evolocumab 140 mg | Percentage Change in Triglycerides | -16 Percentage change of triglycerides | Standard Deviation 23 |
Secondary
Percentage Change in Very Low Density Lipoprotein (VLDL)-Cholesterol
Percentage change in VLDL-cholesterol (measured in mmol/L) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period.
Time frame: Baseline (week 0), week 12
Population: FAS included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NNC0385-0434 15 mg | Percentage Change in Very Low Density Lipoprotein (VLDL)-Cholesterol | 5 Percentage change of VLDL cholesterol | Standard Deviation 27 |
| NNC0385-0434 40 mg | Percentage Change in Very Low Density Lipoprotein (VLDL)-Cholesterol | -7 Percentage change of VLDL cholesterol | Standard Deviation 33 |
| NNC0385-0434 100 mg | Percentage Change in Very Low Density Lipoprotein (VLDL)-Cholesterol | -15 Percentage change of VLDL cholesterol | Standard Deviation 26 |
| Placebo | Percentage Change in Very Low Density Lipoprotein (VLDL)-Cholesterol | 3 Percentage change of VLDL cholesterol | Standard Deviation 41 |
| Evolocumab 140 mg | Percentage Change in Very Low Density Lipoprotein (VLDL)-Cholesterol | -16 Percentage change of VLDL cholesterol | Standard Deviation 24 |