Mixed Dyslipidemia, Primary Hypercholesterolemia
Conditions
Keywords
Evolocumab, Repatha, Statin, Chinese, China, Hypercholesterolemia, Mixed Dyslipidemia, High Cholesterol, Lowering cholesterol
Brief summary
This study is being done to learn more about evolocumab in Chinese people with primary hypercholesterolemia or mixed dyslipidemia. This study will see if evolocumab will reduce low density lipoprotein cholesterol (LDL-C) in Chinese people who are also taking a certain type of lipid-lowering medication (statins with or without ezetimibe) and whether it causes any side effects.
Detailed description
This is a phase 3, multicenter, double-blind, randomized, placebo-controlled study of evolocumab in Chinese participants with hypercholesterolemia and mixed dyslipidemia. Participants who have signed the informed consent form (ICF) will have fasting lipids measured and all inclusion and exclusion criteria assessed. All eligible participants must be taking a maximum appropriate dose of an approved statin, not requiring up titration. Participants should maintain their current diet and exercise regimen. Treatment and follow-up period will be 12 weeks with an additional phone call or other participant contact at week 14 for those receiving investigational product every 2 weeks (Q2W). The end of study (EOS) for participants on once monthly (QM) investigational product is at the week 12 visit, which must be at least 30 days post last dose of investigational product. Evolocumab or placebo will be administered by self-injection under the skin at the study site or in an appropriate non-clinic setting (e.g., at home) by spring based prefilled auto injector/pen (AI/Pen). Participants must tolerate an injection of placebo with a prefilled auto injector/pen device to be used during the study prior to randomization. Participants will be randomly added to 1 of 4 groups using a 2:2:1:1 ratio: evolocumab 140 mg Q2W (86 participants total) evolocumab 420 mg QM (86 participants total) placebo Q2W (44 participants total) placebo QM (43 participants total). The dose frequencies of Q2W and QM will not be blinded but the identity of investigational product evolocumab or placebo will be blinded.
Interventions
DRUGevolocumab
Evolocumab will be administered per pre-filled auto-injector pen (AI/Pen). Participants will receive evolocumab (AMG 145) every 2 weeks or monthly subcutaneously.
DRUGplacebo
Placebo will be administered per pre-filled auto-injector pen (AI/Pen). Participants will receive placebo every 2 weeks or monthly subcutaneously.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The dose frequencies of Q2W and QM will not be blinded but the identity of investigational product (evolocumab or matching SC placebo) will be blinded. In order to protect the blinding of the double-blind treatment period the following labs will be blinded post-investigational product treatment until unblinding of the clinical database and not reported to sites as noted below: • Blinded to the Amgen study team and site staff: lipid panel, Apolipoprotein A1 (ApoA1), Apolipoprotein B (ApoB), lipoprotein(a), high-sensitivity C-reactive protein (hs-CRP), and Proprotein convertase subtilisin/kexin type 9 (PCSK9).
Intervention model description
Participants will be screened for this study and if found eligible as described by the study protocol may be randomized into 1 of 4 groups. Randomized means that you are put into a group by chance. It is like drawing numbers out of a hat. Randomization will be done using a 2:2:1:1 ratio. This means for every 6 participants randomized: * 2 participants will be randomized to evolocumab 140 mg every 2 weeks * 2 participants will be randomized to evolocumab 420 mg once a month * 1 participant will be randomized to placebo every 2 weeks * 1 participant will be randomized to placebo once a month.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Male or female ≥ 18 years of age at signing of informed consent form * On an approved statin, with or without ezetimibe, at optimal stable daily dose(s) for at least 4 weeks before LDL-C screening and, in the opinion of the investigator, not requiring uptitration * Fasting LDL-C as determined by central laboratory at screening ≥ 80 mg/dL * Subject meets at least 1 of the following criteria for high/very high cardiovascular (CV) risk： * history of coronary artery disease * history of ischemic stroke * diagnosis of peripheral artery disease * an estimated glomerular filtration rate (eGFR) as determined by central laboratory at screening of ≥ 30 but \< 60 ml/min/1.73m\^2 * diagnosis of diabetes mellitus type 2 * presence of ≥ 3 of the following risk factors: ≥ 45 years of age if male; ≥ 55 years of age if female; hypertension; smoking; family history of premature cardiovascular disease (CVD; 1st degree of relative: male \< 55 yr, female \< 65 yr); high-density lipoprotein (HDL) cholesterol \< 40 mg/dL; obesity (body mass index ≥ 28 kg/m\^2) OR Subject does not meet high/very high CV risk criteria but fasting LDL-C as determined by central laboratory at screening ≥ 130 mg/dl * Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L) by determined by central laboratory at screening * Subject tolerates a screening placebo injection.
Exclusion criteria
* Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization * Planned coronary or other revascularization within 20 weeks of screening * New York Heart Association (NYHA) III or IV heart failure, or last known left ventricular ejection fraction \< 30 * Uncontrolled serious cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, in the past 3 months prior to randomization * Type 1 diabetes, new-onset (hemoglobin \[Hb\]A1c ≥ 6.5% or fasting plasma glucose (FPG) ≥ 126 mg/dL at screening without known diagnosis) or poorly controlled (HbA1c ≥ 8.5%) type 2 diabetes, as determined by central laboratory at screening * Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) \> 180 mmHg or diastolic blood pressure (DBP) \> 110 mmHg * Subject has taken a cholesterylester transfer protein (CETP) inhibitor in the 12 months prior to randomization * Subject has taken in the 6 weeks prior to LDL-C screening: red yeast rice, \> 200 mg/day niacin, \> 1000 mg/day omega-3 fatty acids (eg, dihydroxyacetone docosahexaenoic acid and eicosapentaenoic acid), stanols or prescription lipid-regulating drugs (eg, bile-acid sequestering resins, fibrates and derivatives) or other cholesterol lowering drugs or lipid-lowering dietary supplements or food additives other than statins and ezetimibe * Treatment 3 months prior to LDL-C screening with any of the following drugs: systemic cyclosporine, systemic steroids, (intravenous \[IV\], intramuscular \[IM\], or by-mouth \[PO\]) (Note: hormone replacement therapy is permitted), vitamin A derivatives and retinol derivatives for the treatment of dermatologic conditions (eg, Accutane) (Note: vitamin A in a multivitamin preparation is permitted) * Uncontrolled hypothyroidism or hyperthyroidism as defined by thyroid stimulating hormone (TSH) \< 1.0 time the lower limit of normal (LLN) or \> 1.5 times the upper limit of normal (ULN), respectively, at screening * Severe renal dysfunction, defined as an eGFR \< 30 ml/min/1.73m\^2 at screening as estimated by Cockcroft-Gault method * Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times the ULN as determined by central laboratory analysis at screening * Creatinine kinase (CK) \> 5 times the ULN at screening * Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) within the last 5 years prior to randomization * Subject has previously received evolocumab or any other therapy to inhibit PCSK9 * Subject has known sensitivity to any of the active substances or their excipients to be administered during dosing, eg, carboxymethylcellulose * Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge. * History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. * Currently receiving treatment in another investigational device or drug study, or less than 30 days before randomization since ending treatment on another investigational device or drug study(s) or planning to receive other investigational procedures while participating in this study * Female subject of childbearing potential not willing to use an acceptable method(s) of effective birth control during treatment with investigational product and for an additional 15 weeks after the end of treatment with investigational product. Female subjects of non-childbearing potential who are not required to use contraception during the study and include those who have had a: * hysterectomy * bilateral salpingectomy * bilateral oophorectomy or * who are postmenopausal i. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. \[A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. ii. Females on HRT and whose menopausal status is in doubt will be required to use one of the non-hormonal highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment. Acceptable methods of effective birth control include: * sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments; the reliability of sexual abstinence must be evaluated in relation to the duration of the trial and the preferred and usual lifestyle of the subject. \[Periodic abstinence (eg., calendar, ovulation, symptothermal, postovulation methods), declaration of abstinence for the duration of a study, and withdrawal are not acceptable methods of contraception\]) * bilateral tubal ligation/occlusion * vasectomized partner (provided that partner is the sole sexual partner of the female subject of childbearing potential and that the vasectomized partner has received medical assessment of the surgical success) * use of hormonal birth control methods (oral, intravaginal (eg. vaginal ring(s), transdermal, injectable, or implantable) * intrauterine devices (IUDs) * intrauterine hormonal releasing system (IUS) * 2 barrier methods (each partner must use 1 barrier method) the male uses a condom and the female must choose either a diaphragm, OR cervical cap, OR contraceptive sponge with spermicide. If spermicide is not commercially available in the country or region, the 2 barrier method without spermicide is acceptable. (A female condom is not an option due to the risk of tearing when both partners use a condom.) * Female subject is pregnant or breast feeding (nursing), planning to become pregnant or planning to breastfeed (nurse) during treatment with investigational product and/or within 15 weeks after the end of treatment with investigational product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Co-Primary Endpoint: Percent Change From Baseline in LDL-C: Mean of Weeks 10 and 12 | Baseline, Weeks 10 and 12 | Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates. |
| Co-Primary Endpoint: Percent Change From Baseline in LDL-C at Week 12 | Baseline, Week 12 | Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in LDL-C: Mean of Weeks 10 and 12 | Baseline, Weeks 10 and 12 | Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates. |
| Percent Change From Baseline in Non-HDL-C at Week 12 | Baseline, Week 12 | Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates. |
| Percent Change From Baseline in Apolipoprotein B (ApoB): Mean of Weeks 10 and 12 | Baseline, Weeks 10 and 12 | Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates. |
| Percent Change From Baseline in ApoB at Week 12 | Baseline and Week 12 | Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates. |
| Percent Change From Baseline in Total Cholesterol: Mean of Weeks 10 and 12 | Baseline, Weeks 10 and 12 | Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates. |
| Percent Change From Baseline in Total Cholesterol at Week 12 | Baseline and Week 12 | Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates. |
| Percentage of Participants With Target LDL-C < 70 mg/dL (1.8 mmol/L): Mean of Weeks 10 and 12 | Weeks 10 and 12 | Percentage of participants who were below the target LDL-C of 70 mg/dL (1.8 mmol/L) based on the mean LDL-C data collected at weeks 10 and 12. |
| Percentage of Participants With Target LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12 | Week 12 | — |
| Percentage of Participants With LDL-C Response: Mean of Weeks 10 and 12 | Baseline, Weeks 10 and 12 | Percentage of participants who had LDL-C response (50% reduction of LDL-C from baseline) based on the mean LDL-C using the data collected at weeks 10 and 12. |
| Change From Baseline in LDL-C at Week 12 | Baseline, Week 12 | Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates. |
| Percent Change From Baseline in Lipoprotein(a) [Lp(a)]: Mean of Weeks 10 and 12 | Baseline, Weeks 10 and 12 | Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates. |
| Percent Change From Baseline in Lp(a) at Week 12 | Baseline and Week 12 | Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates. |
| Percent Change From Baseline in Triglycerides: Mean of Weeks 10 and 12 | Baseline, Weeks 10 and 12 | Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates. |
| Percent Change From Baseline in Triglycerides at Week 12 | Baseline and Week 12 | Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates. |
| Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C): Mean of Weeks 10 and 12 | Baseline, Weeks 10 and 12 | Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates. |
| Percent Change From Baseline in HDL-C at Week 12 | Baseline and Week 12 | Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates. |
| Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol (VLDL-C): Mean of Weeks 10 and 12 | Baseline, Weeks 10 and 12 | Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates. |
| Percent Change From Baseline in VLDL-C at Week 12 | Baseline and Week 12 | Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates. |
| Percentage of Participants With LDL-C Response (50% Reduction of LDL-C From Baseline) at Week 12 | Baseline and Week 12 | LDL-C Response is defined as a 50% reduction of LDL-C from Baseline. |
| Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C): Mean of Weeks 10 and 12 | Baseline, Weeks 10 and 12 | Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates. |
Countries
China
Participant flow
Recruitment details
Participants were enrolled at 31 research centers in China from 09 May 2019 to 20 January 2020.
Pre-assignment details
Participants were randomized 2:2:1:1 into the following treatment arms: evolocumab140 mg subcutaneously (SC) every 2 weeks (Q2W); evolocumab 420 mg SC once monthly (QM); placebo SC Q2W, or placebo SC QM. Randomization was stratified by entry cardiovascular (CV) risk (high/very high vs. not high/very high). Due to Human Genetic Resource Administration office of China (HGRAC) regulations/restrictions, 17 participants were not included in any analysis.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Q2W Placebo SC Q2W for 12 weeks | 41 |
| Placebo QM Placebo SC QM for 12 weeks | 41 |
| Evolocumab 140 mg Q2W Evolocumab 140 mg SC Q2W for 12 weeks | 79 |
| Evolocumab 420 mg QM Evolocumab 420 mg SC QM for 12 weeks | 80 |
| Total | 241 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Decision by Sponsor | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Evolocumab 140 mg Q2W | Evolocumab 420 mg QM | Total | Placebo Q2W | Placebo QM |
|---|---|---|---|---|---|
| Age, Continuous | 61.2 years STANDARD_DEVIATION 10.6 | 60.9 years STANDARD_DEVIATION 9.8 | 60.2 years STANDARD_DEVIATION 10.3 | 57.8 years STANDARD_DEVIATION 9.8 | 59.4 years STANDARD_DEVIATION 10.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 79 Participants | 80 Participants | 241 Participants | 41 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Low-Density Lipoprotein Cholesterol (LDL-C) | 113.7 mg/dL STANDARD_DEVIATION 37.7 | 115.5 mg/dL STANDARD_DEVIATION 30.1 | 116.1 mg/dL STANDARD_DEVIATION 34.6 | 120.9 mg/dL STANDARD_DEVIATION 42.2 | 117.1 mg/dL STANDARD_DEVIATION 28.2 |
| Race/Ethnicity, Customized Asian | 79 Participants | 80 Participants | 241 Participants | 41 Participants | 41 Participants |
| Sex: Female, Male Female | 28 Participants | 29 Participants | 78 Participants | 11 Participants | 10 Participants |
| Sex: Female, Male Male | 51 Participants | 51 Participants | 163 Participants | 30 Participants | 31 Participants |
| Stratification Factor: Cardiovascular (CV) Risk High/Very High CV Risk | 73 Participants | 74 Participants | 222 Participants | 37 Participants | 38 Participants |
| Stratification Factor: Cardiovascular (CV) Risk Not High/Very High CV Risk | 6 Participants | 6 Participants | 19 Participants | 4 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 41 | 0 / 79 | 0 / 80 |
| other Total, other adverse events | 22 / 41 | 22 / 41 | 45 / 79 | 42 / 80 |
| serious Total, serious adverse events | 2 / 41 | 4 / 41 | 6 / 79 | 1 / 80 |
Outcome results
Primary
Co-Primary Endpoint: Percent Change From Baseline in LDL-C at Week 12
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.
Time frame: Baseline, Week 12
Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Co-Primary Endpoint: Percent Change From Baseline in LDL-C at Week 12 | 2.48 percent change | Standard Error 4.18 |
| Evolocumab 140 mg Q2W | Co-Primary Endpoint: Percent Change From Baseline in LDL-C at Week 12 | -68.39 percent change | Standard Error 3.55 |
| Placebo QM | Co-Primary Endpoint: Percent Change From Baseline in LDL-C at Week 12 | 2.72 percent change | Standard Error 4.25 |
| Evolocumab 420 mg QM | Co-Primary Endpoint: Percent Change From Baseline in LDL-C at Week 12 | -63.09 percent change | Standard Error 3.42 |
p-value: <0.000195% CI: [-79.47, -62.27]Repeated measures linear effects model
p-value: <0.000195% CI: [-73.97, -57.66]Repeated measures linear effects model
Primary
Co-Primary Endpoint: Percent Change From Baseline in LDL-C: Mean of Weeks 10 and 12
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.
Time frame: Baseline, Weeks 10 and 12
Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Co-Primary Endpoint: Percent Change From Baseline in LDL-C: Mean of Weeks 10 and 12 | 1.88 percent change | Standard Error 3.72 |
| Evolocumab 140 mg Q2W | Co-Primary Endpoint: Percent Change From Baseline in LDL-C: Mean of Weeks 10 and 12 | -68.86 percent change | Standard Error 3.27 |
| Placebo QM | Co-Primary Endpoint: Percent Change From Baseline in LDL-C: Mean of Weeks 10 and 12 | -0.36 percent change | Standard Error 3.78 |
| Evolocumab 420 mg QM | Co-Primary Endpoint: Percent Change From Baseline in LDL-C: Mean of Weeks 10 and 12 | -70.10 percent change | Standard Error 3.21 |
p-value: <0.000195% CI: [-77.98, -63.48]Repeated measures linear effects model
p-value: <0.000195% CI: [-76.51, -62.97]Repeated measures linear effects model
Secondary
Change From Baseline in LDL-C at Week 12
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.
Time frame: Baseline, Week 12
Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Change From Baseline in LDL-C at Week 12 | -0.8 mg/dL | Standard Error 5.8 |
| Evolocumab 140 mg Q2W | Change From Baseline in LDL-C at Week 12 | -76.7 mg/dL | Standard Error 5.1 |
| Placebo QM | Change From Baseline in LDL-C at Week 12 | -2.1 mg/dL | Standard Error 6.1 |
| Evolocumab 420 mg QM | Change From Baseline in LDL-C at Week 12 | -75.1 mg/dL | Standard Error 5 |
p-value: <0.000195% CI: [-87.1, -64.7]Repeated measures linear effects model
p-value: <0.000195% CI: [-84.1, -61.8]Repeated measures linear effects model
Secondary
Change From Baseline in LDL-C: Mean of Weeks 10 and 12
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.
Time frame: Baseline, Weeks 10 and 12
Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Change From Baseline in LDL-C: Mean of Weeks 10 and 12 | -0.6 mg/dL | Standard Error 5.4 |
| Evolocumab 140 mg Q2W | Change From Baseline in LDL-C: Mean of Weeks 10 and 12 | -77.1 mg/dL | Standard Error 4.8 |
| Placebo QM | Change From Baseline in LDL-C: Mean of Weeks 10 and 12 | -5.8 mg/dL | Standard Error 5.8 |
| Evolocumab 420 mg QM | Change From Baseline in LDL-C: Mean of Weeks 10 and 12 | -83.0 mg/dL | Standard Error 5 |
p-value: <0.000195% CI: [-86.6, -66.4]Repeated measures linear effects model
p-value: <0.000195% CI: [-87.7, -66.7]Repeated measures linear effects model
Secondary
Percentage of Participants With LDL-C Response (50% Reduction of LDL-C From Baseline) at Week 12
LDL-C Response is defined as a 50% reduction of LDL-C from Baseline.
Time frame: Baseline and Week 12
Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with observed data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Q2W | Percentage of Participants With LDL-C Response (50% Reduction of LDL-C From Baseline) at Week 12 | 0.0 percentage of participants |
| Evolocumab 140 mg Q2W | Percentage of Participants With LDL-C Response (50% Reduction of LDL-C From Baseline) at Week 12 | 82.8 percentage of participants |
| Placebo QM | Percentage of Participants With LDL-C Response (50% Reduction of LDL-C From Baseline) at Week 12 | 3.7 percentage of participants |
| Evolocumab 420 mg QM | Percentage of Participants With LDL-C Response (50% Reduction of LDL-C From Baseline) at Week 12 | 86.4 percentage of participants |
p-value: <0.000195% CI: [67.8, 90.1]Cochran-Mantel-Haenszel
p-value: <0.000195% CI: [64.8, 89.7]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With LDL-C Response: Mean of Weeks 10 and 12
Percentage of participants who had LDL-C response (50% reduction of LDL-C from baseline) based on the mean LDL-C using the data collected at weeks 10 and 12.
Time frame: Baseline, Weeks 10 and 12
Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with observed data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Q2W | Percentage of Participants With LDL-C Response: Mean of Weeks 10 and 12 | 0.0 percentage of participants |
| Evolocumab 140 mg Q2W | Percentage of Participants With LDL-C Response: Mean of Weeks 10 and 12 | 87.0 percentage of participants |
| Placebo QM | Percentage of Participants With LDL-C Response: Mean of Weeks 10 and 12 | 5.7 percentage of participants |
| Evolocumab 420 mg QM | Percentage of Participants With LDL-C Response: Mean of Weeks 10 and 12 | 94.4 percentage of participants |
p-value: <0.000195% CI: [73.3, 93]Cochran-Mantel-Haenszel
p-value: <0.000195% CI: [73.5, 94]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Target LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12
Time frame: Week 12
Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with observed data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Q2W | Percentage of Participants With Target LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12 | 0.0 percentage of participants |
| Evolocumab 140 mg Q2W | Percentage of Participants With Target LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12 | 90.6 percentage of participants |
| Placebo QM | Percentage of Participants With Target LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12 | 3.7 percentage of participants |
| Evolocumab 420 mg QM | Percentage of Participants With Target LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12 | 89.4 percentage of participants |
p-value: <0.000195% CI: [76.6, 95.6]Cochran-Mantel-Haenszel
p-value: <0.000195% CI: [68.2, 91.9]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Target LDL-C < 70 mg/dL (1.8 mmol/L): Mean of Weeks 10 and 12
Percentage of participants who were below the target LDL-C of 70 mg/dL (1.8 mmol/L) based on the mean LDL-C data collected at weeks 10 and 12.
Time frame: Weeks 10 and 12
Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with observed data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Q2W | Percentage of Participants With Target LDL-C < 70 mg/dL (1.8 mmol/L): Mean of Weeks 10 and 12 | 2.7 percentage of participants |
| Evolocumab 140 mg Q2W | Percentage of Participants With Target LDL-C < 70 mg/dL (1.8 mmol/L): Mean of Weeks 10 and 12 | 89.9 percentage of participants |
| Placebo QM | Percentage of Participants With Target LDL-C < 70 mg/dL (1.8 mmol/L): Mean of Weeks 10 and 12 | 5.7 percentage of participants |
| Evolocumab 420 mg QM | Percentage of Participants With Target LDL-C < 70 mg/dL (1.8 mmol/L): Mean of Weeks 10 and 12 | 97.2 percentage of participants |
p-value: <0.000195% CI: [72.6, 92.8]Cochran-Mantel-Haenszel
p-value: <0.000195% CI: [76.9, 96.1]Cochran-Mantel-Haenszel
Secondary
Percent Change From Baseline in ApoB at Week 12
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.
Time frame: Baseline and Week 12
Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in ApoB at Week 12 | 2.53 percent change | Standard Error 3.55 |
| Evolocumab 140 mg Q2W | Percent Change From Baseline in ApoB at Week 12 | -53.16 percent change | Standard Error 3.03 |
| Placebo QM | Percent Change From Baseline in ApoB at Week 12 | 1.20 percent change | Standard Error 3.51 |
| Evolocumab 420 mg QM | Percent Change From Baseline in ApoB at Week 12 | -50.01 percent change | Standard Error 2.77 |
p-value: <0.000195% CI: [-62.98, -48.41]Repeated measures linear effects model
p-value: <0.000195% CI: [-58.06, -44.37]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Apolipoprotein B (ApoB): Mean of Weeks 10 and 12
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.
Time frame: Baseline, Weeks 10 and 12
Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Apolipoprotein B (ApoB): Mean of Weeks 10 and 12 | 1.80 percent change | Standard Error 3.17 |
| Evolocumab 140 mg Q2W | Percent Change From Baseline in Apolipoprotein B (ApoB): Mean of Weeks 10 and 12 | -54.45 percent change | Standard Error 2.79 |
| Placebo QM | Percent Change From Baseline in Apolipoprotein B (ApoB): Mean of Weeks 10 and 12 | 0.07 percent change | Standard Error 3 |
| Evolocumab 420 mg QM | Percent Change From Baseline in Apolipoprotein B (ApoB): Mean of Weeks 10 and 12 | -56.93 percent change | Standard Error 2.54 |
p-value: <0.000195% CI: [-62.44, -50.07]Repeated measures linear effects model
p-value: <0.000195% CI: [-62.35, -51.65]Repeated measures linear effects model
Secondary
Percent Change From Baseline in HDL-C at Week 12
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.
Time frame: Baseline and Week 12
Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in HDL-C at Week 12 | 1.95 percent change | Standard Error 2.88 |
| Evolocumab 140 mg Q2W | Percent Change From Baseline in HDL-C at Week 12 | 9.89 percent change | Standard Error 2.49 |
| Placebo QM | Percent Change From Baseline in HDL-C at Week 12 | 0.95 percent change | Standard Error 2.97 |
| Evolocumab 420 mg QM | Percent Change From Baseline in HDL-C at Week 12 | 7.12 percent change | Standard Error 2.33 |
p-value: 0.00895% CI: [2.18, 13.71]Repeated measures linear effects model
p-value: 0.01795% CI: [0.42, 11.92]Repeated measures linear effects model
Secondary
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C): Mean of Weeks 10 and 12
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.
Time frame: Baseline, Weeks 10 and 12
Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C): Mean of Weeks 10 and 12 | 1.01 percent change | Standard Error 2.65 |
| Evolocumab 140 mg Q2W | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C): Mean of Weeks 10 and 12 | 9.45 percent change | Standard Error 2.35 |
| Placebo QM | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C): Mean of Weeks 10 and 12 | 1.86 percent change | Standard Error 2.6 |
| Evolocumab 420 mg QM | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C): Mean of Weeks 10 and 12 | 8.66 percent change | Standard Error 2.18 |
p-value: 0.00895% CI: [3.35, 13.52]Repeated measures linear effects model
p-value: 0.01795% CI: [2.1, 11.5]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Lipoprotein(a) [Lp(a)]: Mean of Weeks 10 and 12
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.
Time frame: Baseline, Weeks 10 and 12
Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Lipoprotein(a) [Lp(a)]: Mean of Weeks 10 and 12 | 4.96 percent change | Standard Error 4.97 |
| Evolocumab 140 mg Q2W | Percent Change From Baseline in Lipoprotein(a) [Lp(a)]: Mean of Weeks 10 and 12 | -43.49 percent change | Standard Error 4.46 |
| Placebo QM | Percent Change From Baseline in Lipoprotein(a) [Lp(a)]: Mean of Weeks 10 and 12 | 11.27 percent change | Standard Error 4.37 |
| Evolocumab 420 mg QM | Percent Change From Baseline in Lipoprotein(a) [Lp(a)]: Mean of Weeks 10 and 12 | -29.16 percent change | Standard Error 3.58 |
p-value: <0.000195% CI: [-57.78, -39.11]Repeated measures linear effects model
p-value: <0.000195% CI: [-48.62, -32.24]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Lp(a) at Week 12
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.
Time frame: Baseline and Week 12
Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Lp(a) at Week 12 | 1.87 percent change | Standard Error 5.21 |
| Evolocumab 140 mg Q2W | Percent Change From Baseline in Lp(a) at Week 12 | -42.83 percent change | Standard Error 4.6 |
| Placebo QM | Percent Change From Baseline in Lp(a) at Week 12 | 14.53 percent change | Standard Error 5.64 |
| Evolocumab 420 mg QM | Percent Change From Baseline in Lp(a) at Week 12 | -23.73 percent change | Standard Error 4.18 |
p-value: <0.000195% CI: [-54.76, -34.65]Repeated measures linear effects model
p-value: <0.000195% CI: [-49.94, -26.59]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Non-HDL-C at Week 12
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.
Time frame: Baseline, Week 12
Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Non-HDL-C at Week 12 | 3.86 percent change | Standard Error 3.85 |
| Evolocumab 140 mg Q2W | Percent Change From Baseline in Non-HDL-C at Week 12 | -57.59 percent change | Standard Error 3.3 |
| Placebo QM | Percent Change From Baseline in Non-HDL-C at Week 12 | 1.78 percent change | Standard Error 3.7 |
| Evolocumab 420 mg QM | Percent Change From Baseline in Non-HDL-C at Week 12 | -54.86 percent change | Standard Error 2.99 |
p-value: <0.000195% CI: [-69.25, -53.65]Repeated measures linear effects model
p-value: <0.000195% CI: [-63.66, -49.63]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C): Mean of Weeks 10 and 12
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.
Time frame: Baseline, Weeks 10 and 12
Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C): Mean of Weeks 10 and 12 | 2.36 percent change | Standard Error 3.52 |
| Evolocumab 140 mg Q2W | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C): Mean of Weeks 10 and 12 | -58.84 percent change | Standard Error 3.1 |
| Placebo QM | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C): Mean of Weeks 10 and 12 | -0.06 percent change | Standard Error 3.3 |
| Evolocumab 420 mg QM | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C): Mean of Weeks 10 and 12 | -62.20 percent change | Standard Error 2.81 |
p-value: <0.000195% CI: [-68.04, -54.37]Repeated measures linear effects model
p-value: <0.000195% CI: [-67.97, -56.32]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Total Cholesterol at Week 12
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.
Time frame: Baseline and Week 12
Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Total Cholesterol at Week 12 | 2.69 percent change | Standard Error 2.99 |
| Evolocumab 140 mg Q2W | Percent Change From Baseline in Total Cholesterol at Week 12 | -40.36 percent change | Standard Error 2.57 |
| Placebo QM | Percent Change From Baseline in Total Cholesterol at Week 12 | 1.17 percent change | Standard Error 2.96 |
| Evolocumab 420 mg QM | Percent Change From Baseline in Total Cholesterol at Week 12 | -39.25 percent change | Standard Error 2.4 |
p-value: <0.000195% CI: [-49.09, -37]Repeated measures linear effects model
p-value: <0.000195% CI: [-45.98, -34.87]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Total Cholesterol: Mean of Weeks 10 and 12
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.
Time frame: Baseline, Weeks 10 and 12
Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Total Cholesterol: Mean of Weeks 10 and 12 | 1.32 percent change | Standard Error 2.74 |
| Evolocumab 140 mg Q2W | Percent Change From Baseline in Total Cholesterol: Mean of Weeks 10 and 12 | -41.42 percent change | Standard Error 2.42 |
| Placebo QM | Percent Change From Baseline in Total Cholesterol: Mean of Weeks 10 and 12 | -0.09 percent change | Standard Error 2.68 |
| Evolocumab 420 mg QM | Percent Change From Baseline in Total Cholesterol: Mean of Weeks 10 and 12 | -44.39 percent change | Standard Error 2.28 |
p-value: <0.000195% CI: [-48.06, -37.41]Repeated measures linear effects model
p-value: <0.000195% CI: [-49.02, -39.58]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Triglycerides at Week 12
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.
Time frame: Baseline and Week 12
Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Triglycerides at Week 12 | 10.01 percent change | Standard Error 5.63 |
| Evolocumab 140 mg Q2W | Percent Change From Baseline in Triglycerides at Week 12 | -7.55 percent change | Standard Error 4.73 |
| Placebo QM | Percent Change From Baseline in Triglycerides at Week 12 | 0.69 percent change | Standard Error 5.56 |
| Evolocumab 420 mg QM | Percent Change From Baseline in Triglycerides at Week 12 | -11.66 percent change | Standard Error 4.37 |
p-value: 0.00895% CI: [-29.42, -5.69]Repeated measures linear effects model
p-value: <0.000195% CI: [-23.04, -1.67]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Triglycerides: Mean of Weeks 10 and 12
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.
Time frame: Baseline, Weeks 10 and 12
Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Triglycerides: Mean of Weeks 10 and 12 | 5.23 percent change | Standard Error 4.77 |
| Evolocumab 140 mg Q2W | Percent Change From Baseline in Triglycerides: Mean of Weeks 10 and 12 | -9.86 percent change | Standard Error 4.19 |
| Placebo QM | Percent Change From Baseline in Triglycerides: Mean of Weeks 10 and 12 | 3.03 percent change | Standard Error 4.85 |
| Evolocumab 420 mg QM | Percent Change From Baseline in Triglycerides: Mean of Weeks 10 and 12 | -16.64 percent change | Standard Error 4.09 |
p-value: 0.00895% CI: [-24.44, -5.75]Repeated measures linear effects model
p-value: <0.000195% CI: [-28.3, -11.05]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol (VLDL-C): Mean of Weeks 10 and 12
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.
Time frame: Baseline, Weeks 10 and 12
Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol (VLDL-C): Mean of Weeks 10 and 12 | 7.08 percent change | Standard Error 5.32 |
| Evolocumab 140 mg Q2W | Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol (VLDL-C): Mean of Weeks 10 and 12 | -15.88 percent change | Standard Error 4.73 |
| Placebo QM | Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol (VLDL-C): Mean of Weeks 10 and 12 | 4.95 percent change | Standard Error 4.97 |
| Evolocumab 420 mg QM | Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol (VLDL-C): Mean of Weeks 10 and 12 | -22.87 percent change | Standard Error 4.21 |
p-value: 0.000295% CI: [-33.12, -12.81]Repeated measures linear effects model
p-value: <0.000195% CI: [-36.6, -19.02]Repeated measures linear effects model
Secondary
Percent Change From Baseline in VLDL-C at Week 12
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.
Time frame: Baseline and Week 12
Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants with baseline and post-baseline assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Q2W | Percent Change From Baseline in VLDL-C at Week 12 | 11.23 percent change | Standard Error 6.12 |
| Evolocumab 140 mg Q2W | Percent Change From Baseline in VLDL-C at Week 12 | -10.55 percent change | Standard Error 5.22 |
| Placebo QM | Percent Change From Baseline in VLDL-C at Week 12 | 1.72 percent change | Standard Error 5.57 |
| Evolocumab 420 mg QM | Percent Change From Baseline in VLDL-C at Week 12 | -14.02 percent change | Standard Error 4.42 |
p-value: 0.000295% CI: [-34.31, -9.25]Repeated measures linear effects model
p-value: <0.000195% CI: [-26.31, -5.18]Repeated measures linear effects model