Hyperlipidemia
Conditions
Keywords
High cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia
Brief summary
The primary objective was to evaluate the effect of 12 weeks of evolocumab administered subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.
Detailed description
Prior to the first randomization, participants entered a screening period to determine eligibility. During screening, all participants received subcutaneous placebo corresponding to the once monthly dose volume. Participants who completed the screening period and met eligibility criteria were randomized to 1 of 5 open-label statin cohorts (atorvastatin 10 mg or 80 mg, rosuvastatin 5 mg or 40 mg, or simvastatin 40 mg) for a 4 week lipid stabilization period based on statin therapy at the time of study entry (no statin use vs non-intensive statin use vs intensive statin use). After the 4-week lipid-stabilization period, eligible patients taking rosuvastatin or simvastatin during the lipid-stabilization phase were then randomized to 1 of 4 treatment groups: evolocumab (140 mg, subcutaneous, every 2 weeks) or matching placebo (subcutaneous, every 2 weeks), or evolocumab (420 mg, subcutaneous, monthly) or matching placebo (subcutaneous, monthly). Patients taking atorvastatin during the lipid-stabilization phase were then randomized to 1 of 6 treatment groups: evolocumab (140 mg, subcutaneous, every 2 weeks) and placebo (oral, daily), evolocumab (420 mg, subcutaneous, monthly) and placebo (oral, daily), placebo (subcutaneous, every 2 weeks) and placebo (oral, daily) or ezetimibe (10 mg, oral, daily), or placebo (subcutaneous, monthly) and placebo (oral, daily) or ezetimibe (10 mg, oral, daily). A participant was considered randomized into the study after successfully completing the screening period, meeting all inclusion/exclusion criteria, and undergoing both randomization procedures. Participants randomized to simvastatin who were taking verapamil or diltiazem prior to randomization received simvastatin 10 mg once daily (QD) while participants who were taking amlodipine, amiodarone or ranolazine prior to randomization received simvastatin 20 mg QD. All other participants randomized to simvastatin received simvastatin 40 mg QD.
Interventions
BIOLOGICALEvolocumab
Administered by subcutaneous injection
DRUGEzetimibe
Administered orally once a day
Administered by subcutaneous injection
Administered orally once a day
DRUGAtorvastatin
Administered orally once a day
DRUGRosuvastatin
Administered orally once a day
DRUGSimvastatin
Administered orally once a day
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female ≥ 18 to ≤ 80 years of age * Subjects not taking a statin must have fasting LDL-C of at least 150 mg/dL (4.0 mmol/L) * Subjects already on a non-intensive statin must have fasting LDL-C at screening ≥ 100 mg/dL (2.6 mmol/L) * Subjects already on a intensive statin must have fasting LDL-C at screening ≥ 80 mg/dL (2.1 mmol/L) * Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
Exclusion criteria
* Statin intolerance * New York Heart association (NYHA) III or IV heart failure * Uncontrolled hypertension * Uncontrolled cardiac arrhythmia * Type 1 diabetes, poorly controlled type 2 diabetes * Uncontrolled hypothyroidism or hyperthyroidism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 |
Secondary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 |
| Percent Change From Baseline in Non-HDL-C at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 |
| Percent Change From Baseline in Apolipoprotein B at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 |
| Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 |
| Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | Baseline and Week 12 |
| Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | Weeks 10 and 12 |
| Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 |
| Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 |
| Percent Change From Baseline in Lipoprotein(a) at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 |
| Percent Change From Baseline in Triglycerides at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 |
| Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 | Baseline and Week 12 |
| Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | Baseline and Weeks 10 and 12 |
| Percent Change From Baseline in HDL-C at Week 12 | Baseline and Week 12 |
| Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | Week 12 |
| Change From Baseline in LDL-C at Week 12 | Baseline and Week 12 |
Countries
Australia, Belgium, Canada, Czechia, Denmark, France, Germany, Hong Kong, Hungary, Italy, Mexico, Netherlands, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
Adults aged 18 to 80 years with screening low-density lipoprotein cholesterol (LDL-C) ≥ 150 mg/dL (no statin at screening), ≥ 100 mg/dL (non-intensive statin at screening), or ≥ 80 mg/dL (intensive statin at screening) and fasting triglycerides ≤ 400 mg/dL. First patient enrolled on 15 January 2013; Last patient enrolled on 10 July 2013.
Pre-assignment details
2067 patients were first randomized to 1 of the 5 open-label statin cohorts (atorvastatin 10 mg or 80 mg, rosuvastatin 5 mg or 40 mg, or simvastatin 40 mg); 1899 were then randomized to blinded investigational product. Randomization into the statin dose cohorts was stratified by entry statin therapy and by use of certain concomitant medications.
Participants by arm
| Arm | Count |
|---|---|
| A10 PBO Q2W Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks. | 56 |
| A10 PBO QM Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks. | 55 |
| A10 EZE (Q2W) Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks. | 56 |
| A10 EZE (QM) Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks. | 55 |
| A10 EvoMab Q2W Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks. | 110 |
| A10 EvoMab QM Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks. | 110 |
| A80 PBO Q2W Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks. | 55 |
| A80 PBO QM Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks. | 55 |
| A80 EZE (Q2W) Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks. | 56 |
| A80 EZE (QM) Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks. | 54 |
| A80 EvoMab Q2W Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks. | 110 |
| A80 EvoMab QM Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks. | 110 |
| R5 PBO Q2W Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks. | 58 |
| R5 PBO QM Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks. | 57 |
| R5 EvoMab Q2W Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. | 114 |
| R5 EvoMab QM Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. | 115 |
| R40 PBO Q2W Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks. | 56 |
| R40 PBO QM Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks. | 56 |
| R40 EvoMab Q2W Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. | 111 |
| R40 EvoMab QM Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. | 112 |
| S40 PBO Q2W Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks. | 56 |
| S40 PBO QM Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks. | 55 |
| S40 EvoMab Q2W Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. | 112 |
| S40 EvoMab QM Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. | 115 |
| Total | 1,899 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 | FG021 | FG022 | FG023 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Decision by sponsor | 0 | 0 | 1 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 6 | 0 | 1 | 0 | 5 | 0 | 0 | 0 | 4 | 0 | 2 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 4 | 0 | 0 | 3 | 4 | 0 | 1 | 1 | 2 | 2 | 2 | 0 | 6 | 3 | 0 | 1 | 1 | 1 | 2 | 1 | 2 | 1 |
Baseline characteristics
| Characteristic | A10 PBO Q2W | A10 PBO QM | A10 EZE (Q2W) | A10 EZE (QM) | A10 EvoMab Q2W | A10 EvoMab QM | A80 PBO Q2W | A80 PBO QM | A80 EZE (Q2W) | A80 EZE (QM) | A80 EvoMab Q2W | A80 EvoMab QM | R5 PBO Q2W | R5 PBO QM | R5 EvoMab Q2W | R5 EvoMab QM | R40 PBO Q2W | R40 PBO QM | R40 EvoMab Q2W | R40 EvoMab QM | S40 PBO Q2W | S40 PBO QM | S40 EvoMab Q2W | S40 EvoMab QM | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 58.3 years STANDARD_DEVIATION 10.5 | 62.2 years STANDARD_DEVIATION 10.4 | 61.0 years STANDARD_DEVIATION 9 | 60.6 years STANDARD_DEVIATION 9.2 | 58.3 years STANDARD_DEVIATION 8.4 | 59.6 years STANDARD_DEVIATION 11.1 | 57.1 years STANDARD_DEVIATION 9.9 | 58.8 years STANDARD_DEVIATION 11.5 | 60.5 years STANDARD_DEVIATION 10.2 | 61.1 years STANDARD_DEVIATION 8.9 | 59.7 years STANDARD_DEVIATION 10.2 | 60.1 years STANDARD_DEVIATION 10.2 | 61.2 years STANDARD_DEVIATION 9.1 | 59.6 years STANDARD_DEVIATION 9.2 | 58.9 years STANDARD_DEVIATION 11.2 | 59.3 years STANDARD_DEVIATION 10.5 | 60.2 years STANDARD_DEVIATION 8.7 | 58.3 years STANDARD_DEVIATION 11.3 | 59.5 years STANDARD_DEVIATION 9.2 | 59.6 years STANDARD_DEVIATION 9 | 61.9 years STANDARD_DEVIATION 9.7 | 61.5 years STANDARD_DEVIATION 10.3 | 59.7 years STANDARD_DEVIATION 9.2 | 61.5 years STANDARD_DEVIATION 9.6 | 59.8 years STANDARD_DEVIATION 9.9 |
| Apolipoprotein B/Apolipoprotein A1 Ratio | 0.666 ratio STANDARD_DEVIATION 0.216 | 0.647 ratio STANDARD_DEVIATION 0.266 | 0.692 ratio STANDARD_DEVIATION 0.243 | 0.640 ratio STANDARD_DEVIATION 0.169 | 0.663 ratio STANDARD_DEVIATION 0.217 | 0.659 ratio STANDARD_DEVIATION 0.249 | 0.603 ratio STANDARD_DEVIATION 0.221 | 0.571 ratio STANDARD_DEVIATION 0.189 | 0.640 ratio STANDARD_DEVIATION 0.234 | 0.560 ratio STANDARD_DEVIATION 0.157 | 0.593 ratio STANDARD_DEVIATION 0.227 | 0.562 ratio STANDARD_DEVIATION 0.171 | 0.661 ratio STANDARD_DEVIATION 0.273 | 0.636 ratio STANDARD_DEVIATION 0.207 | 0.640 ratio STANDARD_DEVIATION 0.249 | 0.676 ratio STANDARD_DEVIATION 0.341 | 0.479 ratio STANDARD_DEVIATION 0.129 | 0.562 ratio STANDARD_DEVIATION 0.217 | 0.538 ratio STANDARD_DEVIATION 0.227 | 0.536 ratio STANDARD_DEVIATION 0.193 | 0.611 ratio STANDARD_DEVIATION 0.179 | 0.581 ratio STANDARD_DEVIATION 0.174 | 0.657 ratio STANDARD_DEVIATION 0.193 | 0.639 ratio STANDARD_DEVIATION 0.224 | 0.614 ratio STANDARD_DEVIATION 0.229 |
| Apolipoprotein B Concentration | 95.3 mg/dL STANDARD_DEVIATION 26 | 95.3 mg/dL STANDARD_DEVIATION 29.6 | 101.3 mg/dL STANDARD_DEVIATION 31.2 | 94.6 mg/dL STANDARD_DEVIATION 20.4 | 99.7 mg/dL STANDARD_DEVIATION 26.4 | 97.3 mg/dL STANDARD_DEVIATION 28.9 | 81.1 mg/dL STANDARD_DEVIATION 22.1 | 80.1 mg/dL STANDARD_DEVIATION 21.4 | 85.3 mg/dL STANDARD_DEVIATION 23.1 | 78.7 mg/dL STANDARD_DEVIATION 16.9 | 79.9 mg/dL STANDARD_DEVIATION 25.1 | 77.9 mg/dL STANDARD_DEVIATION 21.5 | 93.1 mg/dL STANDARD_DEVIATION 27.3 | 95.9 mg/dL STANDARD_DEVIATION 25.2 | 95.4 mg/dL STANDARD_DEVIATION 27 | 97.2 mg/dL STANDARD_DEVIATION 26.9 | 71.0 mg/dL STANDARD_DEVIATION 16.6 | 84.8 mg/dL STANDARD_DEVIATION 29.7 | 77.4 mg/dL STANDARD_DEVIATION 22.3 | 78.7 mg/dL STANDARD_DEVIATION 23.1 | 91.6 mg/dL STANDARD_DEVIATION 18.4 | 89.8 mg/dL STANDARD_DEVIATION 20.7 | 94.2 mg/dL STANDARD_DEVIATION 24 | 96.5 mg/dL STANDARD_DEVIATION 27.5 | 89.1 mg/dL STANDARD_DEVIATION 26.1 |
| HDL-C Concentration | 54.1 mg/dL STANDARD_DEVIATION 16.6 | 57.9 mg/dL STANDARD_DEVIATION 18.4 | 54.1 mg/dL STANDARD_DEVIATION 17.2 | 52.7 mg/dL STANDARD_DEVIATION 13.7 | 56.0 mg/dL STANDARD_DEVIATION 17.9 | 56.1 mg/dL STANDARD_DEVIATION 17.8 | 50.6 mg/dL STANDARD_DEVIATION 15.6 | 50.9 mg/dL STANDARD_DEVIATION 13 | 48.7 mg/dL STANDARD_DEVIATION 12.6 | 51.6 mg/dL STANDARD_DEVIATION 15.1 | 48.5 mg/dL STANDARD_DEVIATION 12.9 | 50.8 mg/dL STANDARD_DEVIATION 13.5 | 52.1 mg/dL STANDARD_DEVIATION 14.9 | 55.5 mg/dL STANDARD_DEVIATION 16 | 54.5 mg/dL STANDARD_DEVIATION 15 | 54.0 mg/dL STANDARD_DEVIATION 16 | 52.8 mg/dL STANDARD_DEVIATION 12.9 | 56.0 mg/dL STANDARD_DEVIATION 18.7 | 53.2 mg/dL STANDARD_DEVIATION 16.4 | 53.8 mg/dL STANDARD_DEVIATION 14.6 | 55.0 mg/dL STANDARD_DEVIATION 14.2 | 59.9 mg/dL STANDARD_DEVIATION 21.8 | 49.7 mg/dL STANDARD_DEVIATION 12.6 | 57.3 mg/dL STANDARD_DEVIATION 17.4 | 53.5 mg/dL STANDARD_DEVIATION 15.9 |
| Lipoprotein(a) Concentration | 31.5 nmol/L | 41.0 nmol/L | 37.0 nmol/L | 33.0 nmol/L | 27.0 nmol/L | 49.0 nmol/L | 53.0 nmol/L | 50.0 nmol/L | 25.0 nmol/L | 61.5 nmol/L | 32.0 nmol/L | 24.5 nmol/L | 34.0 nmol/L | 35.0 nmol/L | 38.0 nmol/L | 32.0 nmol/L | 28.5 nmol/L | 33.0 nmol/L | 41.0 nmol/L | 49.5 nmol/L | 36.5 nmol/L | 28.0 nmol/L | 32.5 nmol/L | 37.0 nmol/L | 34.0 nmol/L |
| Low-Density Lipoprotein Cholesterol (LDL-C) Concentration | 123.0 mg/dL STANDARD_DEVIATION 46.6 | 123.7 mg/dL STANDARD_DEVIATION 47.9 | 126.8 mg/dL STANDARD_DEVIATION 49.6 | 119.3 mg/dL STANDARD_DEVIATION 28.1 | 124.2 mg/dL STANDARD_DEVIATION 43.4 | 126.1 mg/dL STANDARD_DEVIATION 50.4 | 100.3 mg/dL STANDARD_DEVIATION 36.2 | 94.7 mg/dL STANDARD_DEVIATION 31.9 | 98.7 mg/dL STANDARD_DEVIATION 34 | 92.3 mg/dL STANDARD_DEVIATION 19.3 | 94.2 mg/dL STANDARD_DEVIATION 34.8 | 93.8 mg/dL STANDARD_DEVIATION 32.3 | 115.6 mg/dL STANDARD_DEVIATION 39.8 | 119.9 mg/dL STANDARD_DEVIATION 39.1 | 118.7 mg/dL STANDARD_DEVIATION 40.9 | 122.9 mg/dL STANDARD_DEVIATION 42 | 77.4 mg/dL STANDARD_DEVIATION 20.9 | 102.9 mg/dL STANDARD_DEVIATION 49.3 | 88.5 mg/dL STANDARD_DEVIATION 31.5 | 88.5 mg/dL STANDARD_DEVIATION 31.3 | 110.3 mg/dL STANDARD_DEVIATION 28 | 108.6 mg/dL STANDARD_DEVIATION 30.9 | 114.9 mg/dL STANDARD_DEVIATION 34.5 | 123.7 mg/dL STANDARD_DEVIATION 48.5 | 109.1 mg/dL STANDARD_DEVIATION 41.1 |
| Non-High-Density Lipoprotein Cholesterol (non-HDL-C) Concentration | 149.1 mg/dL STANDARD_DEVIATION 46.9 | 147.7 mg/dL STANDARD_DEVIATION 51.4 | 153.8 mg/dL STANDARD_DEVIATION 53.2 | 148.3 mg/dL STANDARD_DEVIATION 36.8 | 152.3 mg/dL STANDARD_DEVIATION 45.6 | 154.3 mg/dL STANDARD_DEVIATION 53.1 | 124.2 mg/dL STANDARD_DEVIATION 39.3 | 116.5 mg/dL STANDARD_DEVIATION 35.7 | 124.8 mg/dL STANDARD_DEVIATION 35.4 | 118.4 mg/dL STANDARD_DEVIATION 25.5 | 120.2 mg/dL STANDARD_DEVIATION 42.3 | 117.2 mg/dL STANDARD_DEVIATION 36.3 | 141.1 mg/dL STANDARD_DEVIATION 41.6 | 148.3 mg/dL STANDARD_DEVIATION 43.3 | 146.6 mg/dL STANDARD_DEVIATION 43.2 | 152.0 mg/dL STANDARD_DEVIATION 46.4 | 103.9 mg/dL STANDARD_DEVIATION 25.7 | 128.7 mg/dL STANDARD_DEVIATION 53.4 | 113.5 mg/dL STANDARD_DEVIATION 36 | 114.3 mg/dL STANDARD_DEVIATION 34.7 | 138.4 mg/dL STANDARD_DEVIATION 29.3 | 135.7 mg/dL STANDARD_DEVIATION 38.4 | 146.8 mg/dL STANDARD_DEVIATION 41.8 | 151.2 mg/dL STANDARD_DEVIATION 51.5 | 150.3 mg/dL STANDARD_DEVIATION 27.6 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 0 participants | 2 participants | 1 participants | 3 participants | 4 participants | 1 participants | 0 participants | 0 participants | 3 participants | 1 participants | 1 participants | 0 participants | 0 participants | 2 participants | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants | 3 participants | 0 participants | 1 participants | 0 participants | 25 participants |
| Race/Ethnicity, Customized Black or African American | 3 participants | 0 participants | 1 participants | 2 participants | 9 participants | 4 participants | 1 participants | 2 participants | 3 participants | 4 participants | 3 participants | 4 participants | 2 participants | 1 participants | 7 participants | 5 participants | 0 participants | 3 participants | 5 participants | 3 participants | 3 participants | 1 participants | 4 participants | 5 participants | 75 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 3 participants | 2 participants | 2 participants | 1 participants | 5 participants | 2 participants | 5 participants | 5 participants | 4 participants | 4 participants | 5 participants | 7 participants | 2 participants | 4 participants | 6 participants | 3 participants | 2 participants | 3 participants | 6 participants | 5 participants | 1 participants | 2 participants | 3 participants | 5 participants | 87 participants |
| Race/Ethnicity, Customized Mixed Race | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 4 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 53 participants | 53 participants | 54 participants | 54 participants | 105 participants | 108 participants | 50 participants | 50 participants | 52 participants | 50 participants | 105 participants | 103 participants | 56 participants | 53 participants | 108 participants | 112 participants | 54 participants | 53 participants | 105 participants | 107 participants | 55 participants | 53 participants | 109 participants | 110 participants | 1812 participants |
| Race/Ethnicity, Customized Other | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 2 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants | 1 participants | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 7 participants |
| Race/Ethnicity, Customized White | 52 participants | 55 participants | 53 participants | 52 participants | 97 participants | 101 participants | 51 participants | 52 participants | 53 participants | 46 participants | 105 participants | 105 participants | 56 participants | 56 participants | 104 participants | 107 participants | 55 participants | 52 participants | 105 participants | 109 participants | 49 participants | 54 participants | 106 participants | 110 participants | 1785 participants |
| Sex: Female, Male Female | 24 Participants | 28 Participants | 29 Participants | 28 Participants | 56 Participants | 44 Participants | 22 Participants | 24 Participants | 24 Participants | 28 Participants | 44 Participants | 48 Participants | 35 Participants | 27 Participants | 52 Participants | 51 Participants | 21 Participants | 27 Participants | 43 Participants | 52 Participants | 32 Participants | 28 Participants | 45 Participants | 59 Participants | 871 Participants |
| Sex: Female, Male Male | 32 Participants | 27 Participants | 27 Participants | 27 Participants | 54 Participants | 66 Participants | 33 Participants | 31 Participants | 32 Participants | 26 Participants | 66 Participants | 62 Participants | 23 Participants | 30 Participants | 62 Participants | 64 Participants | 35 Participants | 29 Participants | 68 Participants | 60 Participants | 24 Participants | 27 Participants | 67 Participants | 56 Participants | 1028 Participants |
| Stratification Factor: Entry Statin Therapy Intensive statin use | 18 participants | 19 participants | 10 participants | 14 participants | 28 participants | 35 participants | 15 participants | 12 participants | 21 participants | 11 participants | 34 participants | 35 participants | 13 participants | 13 participants | 33 participants | 38 participants | 13 participants | 13 participants | 33 participants | 37 participants | 19 participants | 13 participants | 31 participants | 34 participants | 542 participants |
| Stratification Factor: Entry Statin Therapy Non-intensive statin use | 20 participants | 25 participants | 30 participants | 21 participants | 52 participants | 40 participants | 22 participants | 27 participants | 22 participants | 21 participants | 47 participants | 46 participants | 25 participants | 28 participants | 49 participants | 42 participants | 23 participants | 22 participants | 50 participants | 44 participants | 21 participants | 26 participants | 45 participants | 48 participants | 796 participants |
| Stratification Factor: Entry Statin Therapy No statin use | 18 participants | 11 participants | 16 participants | 20 participants | 30 participants | 35 participants | 18 participants | 16 participants | 13 participants | 22 participants | 29 participants | 29 participants | 20 participants | 16 participants | 32 participants | 35 participants | 20 participants | 21 participants | 28 participants | 31 participants | 16 participants | 16 participants | 36 participants | 33 participants | 561 participants |
| Total Cholesterol/HDL-C Ratio | 3.988 ratio STANDARD_DEVIATION 1.154 | 3.859 ratio STANDARD_DEVIATION 1.396 | 4.112 ratio STANDARD_DEVIATION 1.311 | 4.002 ratio STANDARD_DEVIATION 1.1 | 3.980 ratio STANDARD_DEVIATION 1.224 | 4.100 ratio STANDARD_DEVIATION 1.636 | 3.704 ratio STANDARD_DEVIATION 1.26 | 3.461 ratio STANDARD_DEVIATION 1.093 | 3.748 ratio STANDARD_DEVIATION 1.099 | 3.540 ratio STANDARD_DEVIATION 1.1 | 3.696 ratio STANDARD_DEVIATION 1.371 | 3.462 ratio STANDARD_DEVIATION 1 | 4.044 ratio STANDARD_DEVIATION 1.685 | 3.891 ratio STANDARD_DEVIATION 1.234 | 3.915 ratio STANDARD_DEVIATION 1.216 | 4.178 ratio STANDARD_DEVIATION 1.932 | 3.086 ratio STANDARD_DEVIATION 0.728 | 3.547 ratio STANDARD_DEVIATION 1.355 | 3.413 ratio STANDARD_DEVIATION 1.355 | 3.307 ratio STANDARD_DEVIATION 1.061 | 3.733 ratio STANDARD_DEVIATION 1.079 | 3.595 ratio STANDARD_DEVIATION 1.345 | 4.196 ratio STANDARD_DEVIATION 1.436 | 3.924 ratio STANDARD_DEVIATION 1.42 | 3.786 ratio STANDARD_DEVIATION 1.353 |
| Triglyceride Concentration | 112.0 mg/dL | 108.0 mg/dL | 129.5 mg/dL | 119.0 mg/dL | 135.0 mg/dL | 119.0 mg/dL | 104.0 mg/dL | 104.0 mg/dL | 133.0 mg/dL | 109.0 mg/dL | 104.0 mg/dL | 106.5 mg/dL | 112.5 mg/dL | 134.0 mg/dL | 116.0 mg/dL | 121.0 mg/dL | 128.0 mg/dL | 116.0 mg/dL | 102.0 mg/dL | 119.5 mg/dL | 124.0 mg/dL | 106.0 mg/dL | 129.0 mg/dL | 110.0 mg/dL | 116.0 mg/dL |
| Very Low Density Lipoprotein Cholesterol (VLDL-C) Concentration | 22.0 mg/dL | 22.0 mg/dL | 25.5 mg/dL | 24.0 mg/dL | 27.0 mg/dL | 24.0 mg/dL | 21.0 mg/dL | 21.0 mg/dL | 26.5 mg/dL | 22.0 mg/dL | 21.0 mg/dL | 21.0 mg/dL | 22.5 mg/dL | 27.0 mg/dL | 23.0 mg/dL | 24.0 mg/dL | 26.0 mg/dL | 23.0 mg/dL | 20.0 mg/dL | 24.0 mg/dL | 25.0 mg/dL | 21.0 mg/dL | 26.0 mg/dL | 22.0 mg/dL | 23.0 mg/dL |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 56 | 3 / 55 | 9 / 56 | 6 / 55 | 9 / 110 | 7 / 110 | 7 / 55 | 13 / 55 | 8 / 56 | 2 / 54 | 11 / 109 | 9 / 110 | 11 / 58 | 1 / 57 | 6 / 113 | 9 / 115 | 3 / 56 | 8 / 55 | 5 / 111 | 8 / 112 | 3 / 56 | 5 / 55 | 18 / 112 | 11 / 115 |
| serious Total, serious adverse events | 1 / 56 | 2 / 55 | 0 / 56 | 0 / 55 | 4 / 110 | 2 / 110 | 2 / 55 | 1 / 55 | 1 / 56 | 1 / 54 | 3 / 109 | 1 / 110 | 1 / 58 | 2 / 57 | 3 / 113 | 3 / 115 | 2 / 56 | 1 / 55 | 1 / 111 | 3 / 112 | 0 / 56 | 1 / 55 | 2 / 112 | 1 / 115 |
Outcome results
Primary
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| A10 PBO Q2W | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | 8.54 percent change | Standard Error 2.24 |
| A10 PBO QM | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | 0.35 percent change | Standard Error 2.6 |
| A10 EZE (Q2W) | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -23.88 percent change | Standard Error 2.34 |
| A10 EZE (QM) | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -18.98 percent change | Standard Error 2.57 |
| A10 EvoMab Q2W | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -61.41 percent change | Standard Error 1.61 |
| A10 EvoMab QM | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -62.47 percent change | Standard Error 1.83 |
| A80 PBO Q2W | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | 13.12 percent change | Standard Error 3.99 |
| A80 PBO QM | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | 9.76 percent change | Standard Error 3.39 |
| A80 EZE (Q2W) | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -16.85 percent change | Standard Error 3.88 |
| A80 EZE (QM) | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -21.25 percent change | Standard Error 3.42 |
| A80 EvoMab Q2W | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -61.80 percent change | Standard Error 2.77 |
| A80 EvoMab QM | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -65.05 percent change | Standard Error 2.42 |
| R5 PBO Q2W | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | 7.55 percent change | Standard Error 2.39 |
| R5 PBO QM | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | 2.79 percent change | Standard Error 2.5 |
| R5 EvoMab Q2W | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -59.33 percent change | Standard Error 1.74 |
| R5 EvoMab QM | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -63.79 percent change | Standard Error 1.76 |
| R40 PBO Q2W | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | 6.57 percent change | Standard Error 3.11 |
| R40 PBO QM | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -0.02 percent change | Standard Error 3.51 |
| R40 EvoMab Q2W | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -59.08 percent change | Standard Error 2.23 |
| R40 EvoMab QM | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -62.94 percent change | Standard Error 2.44 |
| S40 PBO Q2W | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | 3.26 percent change | Standard Error 3.4 |
| S40 PBO QM | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | 6.00 percent change | Standard Error 4.8 |
| S40 EvoMab Q2W | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -66.17 percent change | Standard Error 2.93 |
| S40 EvoMab QM | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | -62.45 percent change | Standard Error 3.85 |
Comparison: The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-75.38, -64.51]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-69.06, -56.57]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-43.03, -32.03]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-49.7, -37.28]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-84.49, -65.35]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-83, -66.62]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-54.32, -35.57]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-52.06, -35.55]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-72.67, -61.08]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-72.6, -60.56]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-73.19, -58.12]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-71.37, -54.46]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-74.86, -64.01]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-76.68, -60.22]Repeated measures linear effects model
Primary
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time frame: Baseline and Week 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| A10 PBO Q2W | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | 9.86 percent change | Standard Error 2.53 |
| A10 PBO QM | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | 0.97 percent change | Standard Error 2.82 |
| A10 EZE (Q2W) | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -21.96 percent change | Standard Error 2.63 |
| A10 EZE (QM) | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -17.08 percent change | Standard Error 2.78 |
| A10 EvoMab Q2W | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -61.56 percent change | Standard Error 1.81 |
| A10 EvoMab QM | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -58.19 percent change | Standard Error 1.99 |
| A80 PBO Q2W | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | 14.49 percent change | Standard Error 4.42 |
| A80 PBO QM | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | 11.83 percent change | Standard Error 3.85 |
| A80 EZE (Q2W) | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -14.60 percent change | Standard Error 4.29 |
| A80 EZE (QM) | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -19.80 percent change | Standard Error 3.85 |
| A80 EvoMab Q2W | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -61.80 percent change | Standard Error 3.04 |
| A80 EvoMab QM | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -58.68 percent change | Standard Error 2.74 |
| R5 PBO Q2W | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | 8.12 percent change | Standard Error 2.68 |
| R5 PBO QM | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | 5.10 percent change | Standard Error 2.62 |
| R5 EvoMab Q2W | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -60.09 percent change | Standard Error 1.94 |
| R5 EvoMab QM | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -59.40 percent change | Standard Error 1.87 |
| R40 PBO Q2W | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | 9.42 percent change | Standard Error 3.6 |
| R40 PBO QM | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | 2.59 percent change | Standard Error 4.3 |
| R40 EvoMab Q2W | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -58.89 percent change | Standard Error 2.58 |
| R40 EvoMab QM | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -52.40 percent change | Standard Error 2.98 |
| S40 PBO Q2W | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | 4.70 percent change | Standard Error 3.61 |
| S40 PBO QM | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | 3.40 percent change | Standard Error 4.94 |
| S40 EvoMab Q2W | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -65.86 percent change | Standard Error 3.05 |
| S40 EvoMab QM | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | -57.02 percent change | Standard Error 3.93 |
Comparison: The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-77.55, -65.29]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-65.94, -52.38]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-45.81, -33.4]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-47.83, -34.37]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-86.87, -65.72]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-79.81, -61.2]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-57.54, -36.86]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-48.21, -29.56]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-74.72, -61.7]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-70.84, -58.14]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-77.04, -59.57]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-65.31, -44.65]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-76.72, -64.41]Repeated measures linear effects model
Comparison: The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.p-value: <0.00195% CI: [-69.11, -51.72]Repeated measures linear effects model
Secondary
Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| A10 PBO Q2W | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | 6.8 mg/dL | Standard Error 3.7 |
| A10 PBO QM | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | -0.4 mg/dL | Standard Error 4.4 |
| A10 EZE (Q2W) | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | -32.4 mg/dL | Standard Error 3.8 |
| A10 EZE (QM) | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | -25.1 mg/dL | Standard Error 4.3 |
| A10 EvoMab Q2W | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | -76.8 mg/dL | Standard Error 2.7 |
| A10 EvoMab QM | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | -80.1 mg/dL | Standard Error 3.1 |
| A80 PBO Q2W | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | 11.0 mg/dL | Standard Error 5 |
| A80 PBO QM | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | 5.5 mg/dL | Standard Error 3.7 |
| A80 EZE (Q2W) | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | -13.0 mg/dL | Standard Error 4.9 |
| A80 EZE (QM) | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | -21.3 mg/dL | Standard Error 3.7 |
| A80 EvoMab Q2W | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | -58.8 mg/dL | Standard Error 3.5 |
| A80 EvoMab QM | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | -60.1 mg/dL | Standard Error 2.6 |
| R5 PBO Q2W | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | 6.5 mg/dL | Standard Error 3.5 |
| R5 PBO QM | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | 0.1 mg/dL | Standard Error 4.2 |
| R5 EvoMab Q2W | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | -68.9 mg/dL | Standard Error 2.5 |
| R5 EvoMab QM | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | -77.8 mg/dL | Standard Error 3 |
| R40 PBO Q2W | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | 3.4 mg/dL | Standard Error 3 |
| R40 PBO QM | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | -4.8 mg/dL | Standard Error 4.2 |
| R40 EvoMab Q2W | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | -52.3 mg/dL | Standard Error 2.2 |
| R40 EvoMab QM | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | -55.3 mg/dL | Standard Error 2.9 |
| S40 PBO Q2W | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | -5.7 mg/dL | Standard Error 5.2 |
| S40 PBO QM | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | 1.7 mg/dL | Standard Error 6.5 |
| S40 EvoMab Q2W | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | -83.8 mg/dL | Standard Error 4.5 |
| S40 EvoMab QM | Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12 | -78.4 mg/dL | Standard Error 5.1 |
p-value: <0.00195% CI: [-92.6, -74.6]Repeated measures linear effects model
p-value: <0.00195% CI: [-90.2, -69.2]Repeated measures linear effects model
p-value: <0.00195% CI: [-53.4, -35.3]Repeated measures linear effects model
p-value: <0.00195% CI: [-65.4, -44.6]Repeated measures linear effects model
p-value: <0.00195% CI: [-81.9, -57.8]Repeated measures linear effects model
p-value: <0.00195% CI: [-74.5, -56.7]Repeated measures linear effects model
p-value: <0.00195% CI: [-57.7, -33.9]Repeated measures linear effects model
p-value: <0.00195% CI: [-47.8, -29.9]Repeated measures linear effects model
p-value: <0.00195% CI: [-83.9, -67]Repeated measures linear effects model
p-value: <0.00195% CI: [-88, -67.8]Repeated measures linear effects model
p-value: <0.00195% CI: [-63.1, -48.4]Repeated measures linear effects model
p-value: <0.00195% CI: [-60.6, -40.6]Repeated measures linear effects model
p-value: <0.00195% CI: [-86.2, -70]Repeated measures linear effects model
p-value: <0.00195% CI: [-91.7, -68.6]Repeated measures linear effects model
Secondary
Change From Baseline in LDL-C at Week 12
Time frame: Baseline and Week 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| A10 PBO Q2W | Change From Baseline in LDL-C at Week 12 | 8.6 mg/dL | Standard Error 4 |
| A10 PBO QM | Change From Baseline in LDL-C at Week 12 | 0.8 mg/dL | Standard Error 4.5 |
| A10 EZE (Q2W) | Change From Baseline in LDL-C at Week 12 | -30.1 mg/dL | Standard Error 4.1 |
| A10 EZE (QM) | Change From Baseline in LDL-C at Week 12 | -23.3 mg/dL | Standard Error 4.5 |
| A10 EvoMab Q2W | Change From Baseline in LDL-C at Week 12 | -77.0 mg/dL | Standard Error 2.9 |
| A10 EvoMab QM | Change From Baseline in LDL-C at Week 12 | -75.1 mg/dL | Standard Error 3.2 |
| A80 PBO Q2W | Change From Baseline in LDL-C at Week 12 | 12.7 mg/dL | Standard Error 5.3 |
| A80 PBO QM | Change From Baseline in LDL-C at Week 12 | 7.0 mg/dL | Standard Error 4.1 |
| A80 EZE (Q2W) | Change From Baseline in LDL-C at Week 12 | -9.9 mg/dL | Standard Error 5.2 |
| A80 EZE (QM) | Change From Baseline in LDL-C at Week 12 | -19.5 mg/dL | Standard Error 4.1 |
| A80 EvoMab Q2W | Change From Baseline in LDL-C at Week 12 | -59.0 mg/dL | Standard Error 3.7 |
| A80 EvoMab QM | Change From Baseline in LDL-C at Week 12 | -54.8 mg/dL | Standard Error 2.9 |
| R5 PBO Q2W | Change From Baseline in LDL-C at Week 12 | 7.8 mg/dL | Standard Error 3.8 |
| R5 PBO QM | Change From Baseline in LDL-C at Week 12 | 2.4 mg/dL | Standard Error 4.4 |
| R5 EvoMab Q2W | Change From Baseline in LDL-C at Week 12 | -69.2 mg/dL | Standard Error 2.7 |
| R5 EvoMab QM | Change From Baseline in LDL-C at Week 12 | -73.3 mg/dL | Standard Error 3.1 |
| R40 PBO Q2W | Change From Baseline in LDL-C at Week 12 | 5.1 mg/dL | Standard Error 3.2 |
| R40 PBO QM | Change From Baseline in LDL-C at Week 12 | -2.0 mg/dL | Standard Error 4.7 |
| R40 EvoMab Q2W | Change From Baseline in LDL-C at Week 12 | -52.1 mg/dL | Standard Error 2.3 |
| R40 EvoMab QM | Change From Baseline in LDL-C at Week 12 | -46.7 mg/dL | Standard Error 3.3 |
| S40 PBO Q2W | Change From Baseline in LDL-C at Week 12 | -4.5 mg/dL | Standard Error 5.3 |
| S40 PBO QM | Change From Baseline in LDL-C at Week 12 | -0.6 mg/dL | Standard Error 6.6 |
| S40 EvoMab Q2W | Change From Baseline in LDL-C at Week 12 | -83.5 mg/dL | Standard Error 4.6 |
| S40 EvoMab QM | Change From Baseline in LDL-C at Week 12 | -72.5 mg/dL | Standard Error 5.2 |
p-value: <0.00195% CI: [-95.2, -75.9]Repeated measures linear effects model
p-value: <0.00195% CI: [-86.8, -64.9]Repeated measures linear effects model
p-value: <0.00195% CI: [-56.6, -37.1]Repeated measures linear effects model
p-value: <0.00195% CI: [-62.6, -40.9]Repeated measures linear effects model
p-value: <0.00195% CI: [-84.4, -59]Repeated measures linear effects model
p-value: <0.00195% CI: [-71.6, -52]Repeated measures linear effects model
p-value: <0.00195% CI: [-61.5, -36.6]Repeated measures linear effects model
p-value: <0.00195% CI: [-45.2, -25.5]Repeated measures linear effects model
p-value: <0.00195% CI: [-86.2, -67.9]Repeated measures linear effects model
p-value: <0.00195% CI: [-86.3, -65.3]Repeated measures linear effects model
p-value: <0.00195% CI: [-65.1, -49.4]Repeated measures linear effects model
p-value: <0.00195% CI: [-55.9, -33.4]Repeated measures linear effects model
p-value: <0.00195% CI: [-87.5, -70.4]Repeated measures linear effects model
p-value: <0.00195% CI: [-83.8, -60]Repeated measures linear effects model
Secondary
Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL
Time frame: Weeks 10 and 12
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A10 PBO Q2W | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 5.7 percentage of participants |
| A10 PBO QM | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 5.6 percentage of participants |
| A10 EZE (Q2W) | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 20.0 percentage of participants |
| A10 EZE (QM) | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 16.7 percentage of participants |
| A10 EvoMab Q2W | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 88.1 percentage of participants |
| A10 EvoMab QM | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 85.8 percentage of participants |
| A80 PBO Q2W | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 13.7 percentage of participants |
| A80 PBO QM | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 9.3 percentage of participants |
| A80 EZE (Q2W) | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 50.9 percentage of participants |
| A80 EZE (QM) | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 62.3 percentage of participants |
| A80 EvoMab Q2W | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 94.4 percentage of participants |
| A80 EvoMab QM | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 92.5 percentage of participants |
| R5 PBO Q2W | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 7.0 percentage of participants |
| R5 PBO QM | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 5.3 percentage of participants |
| R5 EvoMab Q2W | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 88.7 percentage of participants |
| R5 EvoMab QM | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 89.9 percentage of participants |
| R40 PBO Q2W | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 38.9 percentage of participants |
| R40 PBO QM | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 28.8 percentage of participants |
| R40 EvoMab Q2W | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 93.5 percentage of participants |
| R40 EvoMab QM | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 94.5 percentage of participants |
| S40 PBO Q2W | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 1.9 percentage of participants |
| S40 PBO QM | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 3.9 percentage of participants |
| S40 EvoMab Q2W | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 93.6 percentage of participants |
| S40 EvoMab QM | Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL | 88.5 percentage of participants |
p-value: <0.00195% CI: [70.2, 88.5]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [67.9, 86.8]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [53.1, 78.1]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [54.8, 78.5]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [67.3, 88.3]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [70.7, 89.6]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [29.5, 56.7]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [16.7, 44.2]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [69.5, 88]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [73.1, 90.2]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [39.8, 66.9]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [51, 76.6]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [81.6, 95.3]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [72.8, 90]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12
Time frame: Week 12
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A10 PBO Q2W | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 2.0 percentage of participants |
| A10 PBO QM | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 5.9 percentage of participants |
| A10 EZE (Q2W) | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 22.4 percentage of participants |
| A10 EZE (QM) | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 19.2 percentage of participants |
| A10 EvoMab Q2W | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 85.4 percentage of participants |
| A10 EvoMab QM | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 84.2 percentage of participants |
| A80 PBO Q2W | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 13.0 percentage of participants |
| A80 PBO QM | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 9.8 percentage of participants |
| A80 EZE (Q2W) | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 52.0 percentage of participants |
| A80 EZE (QM) | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 55.8 percentage of participants |
| A80 EvoMab Q2W | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 93.1 percentage of participants |
| A80 EvoMab QM | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 91.0 percentage of participants |
| R5 PBO Q2W | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 7.7 percentage of participants |
| R5 PBO QM | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 5.5 percentage of participants |
| R5 EvoMab Q2W | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 85.0 percentage of participants |
| R5 EvoMab QM | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 86.5 percentage of participants |
| R40 PBO Q2W | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 39.6 percentage of participants |
| R40 PBO QM | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 28.0 percentage of participants |
| R40 EvoMab Q2W | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 92.3 percentage of participants |
| R40 EvoMab QM | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 92.3 percentage of participants |
| S40 PBO Q2W | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 1.9 percentage of participants |
| S40 PBO QM | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 6.4 percentage of participants |
| S40 EvoMab Q2W | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 94.4 percentage of participants |
| S40 EvoMab QM | Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 | 84.8 percentage of participants |
p-value: <0.00195% CI: [71.9, 89.2]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [65.2, 85.3]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [47.3, 73.9]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [49.8, 75.2]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [65.8, 87.9]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [67.9, 88.1]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [26.4, 55.1]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [20.7, 49.3]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [63.9, 84.7]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [68.8, 87.5]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [37.6, 65.3]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [49.1, 75.5]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [82.3, 95.9]Cochran-Mantel-Haenszel
p-value: <0.00195% CI: [64.9, 85.4]Cochran-Mantel-Haenszel
Secondary
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| A10 PBO Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | 6.41 percent change | Standard Error 2.03 |
| A10 PBO QM | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | 0.78 percent change | Standard Error 2.29 |
| A10 EZE (Q2W) | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | -15.77 percent change | Standard Error 2.14 |
| A10 EZE (QM) | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | -11.47 percent change | Standard Error 2.29 |
| A10 EvoMab Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | -53.56 percent change | Standard Error 1.48 |
| A10 EvoMab QM | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | -53.33 percent change | Standard Error 1.58 |
| A80 PBO Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | 4.48 percent change | Standard Error 3.04 |
| A80 PBO QM | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | 5.79 percent change | Standard Error 2.79 |
| A80 EZE (Q2W) | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | -15.17 percent change | Standard Error 2.99 |
| A80 EZE (QM) | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | -12.91 percent change | Standard Error 2.8 |
| A80 EvoMab Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | -52.43 percent change | Standard Error 2.14 |
| A80 EvoMab QM | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | -56.20 percent change | Standard Error 1.98 |
| R5 PBO Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | 2.82 percent change | Standard Error 2.26 |
| R5 PBO QM | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | 2.58 percent change | Standard Error 2.05 |
| R5 EvoMab Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | -52.46 percent change | Standard Error 1.67 |
| R5 EvoMab QM | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | -56.66 percent change | Standard Error 1.43 |
| R40 PBO Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | 2.17 percent change | Standard Error 2.56 |
| R40 PBO QM | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | 2.60 percent change | Standard Error 2.97 |
| R40 EvoMab Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | -48.47 percent change | Standard Error 1.83 |
| R40 EvoMab QM | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | -54.17 percent change | Standard Error 2.04 |
| S40 PBO Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | -1.00 percent change | Standard Error 3.12 |
| S40 PBO QM | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | -1.42 percent change | Standard Error 4.22 |
| S40 EvoMab Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | -58.76 percent change | Standard Error 2.73 |
| S40 EvoMab QM | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | -57.47 percent change | Standard Error 3.55 |
p-value: <0.00195% CI: [-64.91, -55.03]Repeated measures linear effects model
p-value: <0.00195% CI: [-59.57, -48.64]Repeated measures linear effects model
p-value: <0.00195% CI: [-42.8, -32.77]Repeated measures linear effects model
p-value: <0.00195% CI: [-47.34, -36.67]Repeated measures linear effects model
p-value: <0.00195% CI: [-64.22, -49.59]Repeated measures linear effects model
p-value: <0.00195% CI: [-68.68, -55.29]Repeated measures linear effects model
p-value: <0.00195% CI: [-44.48, -30.04]Repeated measures linear effects model
p-value: <0.00195% CI: [-50.07, -36.51]Repeated measures linear effects model
p-value: <0.00195% CI: [-60.79, -49.79]Repeated measures linear effects model
p-value: <0.00195% CI: [-64.16, -54.32]Repeated measures linear effects model
p-value: <0.00195% CI: [-56.82, -44.45]Repeated measures linear effects model
p-value: <0.00195% CI: [-63.91, -49.64]Repeated measures linear effects model
p-value: <0.00195% CI: [-62.51, -52.99]Repeated measures linear effects model
p-value: <0.00195% CI: [-61.85, -50.27]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
Time frame: Baseline and Week 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| A10 PBO Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | 6.13 percent change | Standard Error 2.2 |
| A10 PBO QM | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | -1.21 percent change | Standard Error 2.41 |
| A10 EZE (Q2W) | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | -14.51 percent change | Standard Error 2.31 |
| A10 EZE (QM) | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | -12.33 percent change | Standard Error 2.41 |
| A10 EvoMab Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | -54.17 percent change | Standard Error 1.59 |
| A10 EvoMab QM | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | -49.65 percent change | Standard Error 1.69 |
| A80 PBO Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | 4.19 percent change | Standard Error 3.25 |
| A80 PBO QM | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | 6.50 percent change | Standard Error 3.18 |
| A80 EZE (Q2W) | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | -13.69 percent change | Standard Error 3.17 |
| A80 EZE (QM) | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | -12.19 percent change | Standard Error 3.17 |
| A80 EvoMab Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | -53.59 percent change | Standard Error 2.26 |
| A80 EvoMab QM | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | -50.76 percent change | Standard Error 2.26 |
| R5 PBO Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | 1.44 percent change | Standard Error 2.3 |
| R5 PBO QM | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | 4.00 percent change | Standard Error 2.27 |
| R5 EvoMab Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | -52.97 percent change | Standard Error 1.69 |
| R5 EvoMab QM | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | -52.13 percent change | Standard Error 1.6 |
| R40 PBO Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | 1.64 percent change | Standard Error 2.75 |
| R40 PBO QM | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | 3.16 percent change | Standard Error 3.51 |
| R40 EvoMab Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | -47.53 percent change | Standard Error 1.96 |
| R40 EvoMab QM | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | -45.65 percent change | Standard Error 2.39 |
| S40 PBO Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | -1.80 percent change | Standard Error 3.21 |
| S40 PBO QM | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | -0.52 percent change | Standard Error 4.29 |
| S40 EvoMab Q2W | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | -59.53 percent change | Standard Error 2.77 |
| S40 EvoMab QM | Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12 | -52.56 percent change | Standard Error 3.59 |
p-value: <0.00195% CI: [-65.65, -54.94]Repeated measures linear effects model
p-value: <0.00195% CI: [-54.23, -42.65]Repeated measures linear effects model
p-value: <0.00195% CI: [-45.09, -34.23]Repeated measures linear effects model
p-value: <0.00195% CI: [-43.12, -31.52]Repeated measures linear effects model
p-value: <0.00195% CI: [-65.55, -49.99]Repeated measures linear effects model
p-value: <0.00195% CI: [-64.91, -49.6]Repeated measures linear effects model
p-value: <0.00195% CI: [-47.53, -32.26]Repeated measures linear effects model
p-value: <0.00195% CI: [-46.26, -30.88]Repeated measures linear effects model
p-value: <0.00195% CI: [-59.99, -48.82]Repeated measures linear effects model
p-value: <0.00195% CI: [-61.58, -50.68]Repeated measures linear effects model
p-value: <0.00195% CI: [-55.8, -42.53]Repeated measures linear effects model
p-value: <0.00195% CI: [-57.21, -40.4]Repeated measures linear effects model
p-value: <0.00195% CI: [-62.82, -52.65]Repeated measures linear effects model
p-value: <0.00195% CI: [-58.1, -45.98]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| A10 PBO Q2W | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | 7.55 percent change | Standard Error 1.89 |
| A10 PBO QM | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | 0.81 percent change | Standard Error 2.19 |
| A10 EZE (Q2W) | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | -17.29 percent change | Standard Error 2 |
| A10 EZE (QM) | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | -11.43 percent change | Standard Error 2.2 |
| A10 EvoMab Q2W | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | -50.95 percent change | Standard Error 1.38 |
| A10 EvoMab QM | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | -51.44 percent change | Standard Error 1.52 |
| A80 PBO Q2W | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | 10.20 percent change | Standard Error 3.02 |
| A80 PBO QM | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | 5.48 percent change | Standard Error 2.83 |
| A80 EZE (Q2W) | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | -14.22 percent change | Standard Error 2.98 |
| A80 EZE (QM) | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | -13.62 percent change | Standard Error 2.87 |
| A80 EvoMab Q2W | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | -49.14 percent change | Standard Error 2.13 |
| A80 EvoMab QM | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | -53.26 percent change | Standard Error 2.02 |
| R5 PBO Q2W | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | 5.07 percent change | Standard Error 1.97 |
| R5 PBO QM | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | 2.54 percent change | Standard Error 1.89 |
| R5 EvoMab Q2W | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | -49.79 percent change | Standard Error 1.46 |
| R5 EvoMab QM | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | -53.59 percent change | Standard Error 1.32 |
| R40 PBO Q2W | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | 3.71 percent change | Standard Error 2.46 |
| R40 PBO QM | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | 1.98 percent change | Standard Error 2.57 |
| R40 EvoMab Q2W | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | -47.07 percent change | Standard Error 1.76 |
| R40 EvoMab QM | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | -52.95 percent change | Standard Error 1.76 |
| S40 PBO Q2W | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | -0.31 percent change | Standard Error 3.02 |
| S40 PBO QM | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | 2.49 percent change | Standard Error 4.67 |
| S40 EvoMab Q2W | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | -55.65 percent change | Standard Error 2.63 |
| S40 EvoMab QM | Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 | -54.37 percent change | Standard Error 3.93 |
p-value: <0.00195% CI: [-63.1, -53.89]Repeated measures linear effects model
p-value: <0.00195% CI: [-57.49, -47.01]Repeated measures linear effects model
p-value: <0.00195% CI: [-38.33, -28.98]Repeated measures linear effects model
p-value: <0.00195% CI: [-45.27, -34.74]Repeated measures linear effects model
p-value: <0.00195% CI: [-66.61, -52.07]Repeated measures linear effects model
p-value: <0.00195% CI: [-65.56, -51.93]Repeated measures linear effects model
p-value: <0.00195% CI: [-42.09, -27.75]Repeated measures linear effects model
p-value: <0.00195% CI: [-46.57, -32.71]Repeated measures linear effects model
p-value: <0.00195% CI: [-59.66, -50.05]Repeated measures linear effects model
p-value: <0.00195% CI: [-60.66, -51.61]Repeated measures linear effects model
p-value: <0.00195% CI: [-56.72, -44.83]Repeated measures linear effects model
p-value: <0.00195% CI: [-61.11, -48.76]Repeated measures linear effects model
p-value: <0.00195% CI: [-59.94, -50.74]Repeated measures linear effects model
p-value: <0.00195% CI: [-63.27, -50.46]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Apolipoprotein B at Week 12
Time frame: Baseline and Week 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| A10 PBO Q2W | Percent Change From Baseline in Apolipoprotein B at Week 12 | 7.89 percent change | Standard Error 2.16 |
| A10 PBO QM | Percent Change From Baseline in Apolipoprotein B at Week 12 | 0.21 percent change | Standard Error 2.43 |
| A10 EZE (Q2W) | Percent Change From Baseline in Apolipoprotein B at Week 12 | -15.98 percent change | Standard Error 2.26 |
| A10 EZE (QM) | Percent Change From Baseline in Apolipoprotein B at Week 12 | -10.95 percent change | Standard Error 2.44 |
| A10 EvoMab Q2W | Percent Change From Baseline in Apolipoprotein B at Week 12 | -50.90 percent change | Standard Error 1.56 |
| A10 EvoMab QM | Percent Change From Baseline in Apolipoprotein B at Week 12 | -47.15 percent change | Standard Error 1.7 |
| A80 PBO Q2W | Percent Change From Baseline in Apolipoprotein B at Week 12 | 11.64 percent change | Standard Error 3.28 |
| A80 PBO QM | Percent Change From Baseline in Apolipoprotein B at Week 12 | 6.54 percent change | Standard Error 3.22 |
| A80 EZE (Q2W) | Percent Change From Baseline in Apolipoprotein B at Week 12 | -12.31 percent change | Standard Error 3.2 |
| A80 EZE (QM) | Percent Change From Baseline in Apolipoprotein B at Week 12 | -12.16 percent change | Standard Error 3.24 |
| A80 EvoMab Q2W | Percent Change From Baseline in Apolipoprotein B at Week 12 | -49.77 percent change | Standard Error 2.28 |
| A80 EvoMab QM | Percent Change From Baseline in Apolipoprotein B at Week 12 | -46.47 percent change | Standard Error 2.31 |
| R5 PBO Q2W | Percent Change From Baseline in Apolipoprotein B at Week 12 | 6.35 percent change | Standard Error 2.1 |
| R5 PBO QM | Percent Change From Baseline in Apolipoprotein B at Week 12 | 4.63 percent change | Standard Error 2.11 |
| R5 EvoMab Q2W | Percent Change From Baseline in Apolipoprotein B at Week 12 | -50.15 percent change | Standard Error 1.54 |
| R5 EvoMab QM | Percent Change From Baseline in Apolipoprotein B at Week 12 | -48.58 percent change | Standard Error 1.49 |
| R40 PBO Q2W | Percent Change From Baseline in Apolipoprotein B at Week 12 | 4.91 percent change | Standard Error 2.71 |
| R40 PBO QM | Percent Change From Baseline in Apolipoprotein B at Week 12 | 3.24 percent change | Standard Error 3.13 |
| R40 EvoMab Q2W | Percent Change From Baseline in Apolipoprotein B at Week 12 | -45.61 percent change | Standard Error 1.93 |
| R40 EvoMab QM | Percent Change From Baseline in Apolipoprotein B at Week 12 | -43.71 percent change | Standard Error 2.13 |
| S40 PBO Q2W | Percent Change From Baseline in Apolipoprotein B at Week 12 | 0.35 percent change | Standard Error 3.17 |
| S40 PBO QM | Percent Change From Baseline in Apolipoprotein B at Week 12 | 3.57 percent change | Standard Error 4.74 |
| S40 EvoMab Q2W | Percent Change From Baseline in Apolipoprotein B at Week 12 | -55.95 percent change | Standard Error 2.72 |
| S40 EvoMab QM | Percent Change From Baseline in Apolipoprotein B at Week 12 | -49.16 percent change | Standard Error 3.97 |
p-value: <0.00195% CI: [-64.03, -53.55]Repeated measures linear effects model
p-value: <0.00195% CI: [-53.2, -41.52]Repeated measures linear effects model
p-value: <0.00195% CI: [-40.23, -29.6]Repeated measures linear effects model
p-value: <0.00195% CI: [-42.06, -30.35]Repeated measures linear effects model
p-value: <0.00195% CI: [-69.27, -53.54]Repeated measures linear effects model
p-value: <0.00195% CI: [-60.77, -45.25]Repeated measures linear effects model
p-value: <0.00195% CI: [-45.17, -29.74]Repeated measures linear effects model
p-value: <0.00195% CI: [-42.15, -26.47]Repeated measures linear effects model
p-value: <0.00195% CI: [-61.6, -51.4]Repeated measures linear effects model
p-value: <0.00195% CI: [-58.29, -48.13]Repeated measures linear effects model
p-value: <0.00195% CI: [-57.06, -43.99]Repeated measures linear effects model
p-value: <0.00195% CI: [-54.43, -39.47]Repeated measures linear effects model
p-value: <0.00195% CI: [-61.47, -51.14]Repeated measures linear effects model
p-value: <0.00195% CI: [-59.4, -46.06]Repeated measures linear effects model
Secondary
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| A10 PBO Q2W | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | -0.99 percent change | Standard Error 1.5 |
| A10 PBO QM | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | -0.45 percent change | Standard Error 1.94 |
| A10 EZE (Q2W) | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | -1.13 percent change | Standard Error 1.56 |
| A10 EZE (QM) | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | -0.92 percent change | Standard Error 1.92 |
| A10 EvoMab Q2W | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | 5.54 percent change | Standard Error 1.07 |
| A10 EvoMab QM | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | 7.66 percent change | Standard Error 1.37 |
| A80 PBO Q2W | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | 4.48 percent change | Standard Error 1.73 |
| A80 PBO QM | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | -1.37 percent change | Standard Error 1.85 |
| A80 EZE (Q2W) | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | 0.86 percent change | Standard Error 1.68 |
| A80 EZE (QM) | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | -0.59 percent change | Standard Error 1.86 |
| A80 EvoMab Q2W | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | 8.44 percent change | Standard Error 1.2 |
| A80 EvoMab QM | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | 7.76 percent change | Standard Error 1.31 |
| R5 PBO Q2W | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | 0.87 percent change | Standard Error 1.52 |
| R5 PBO QM | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | -0.94 percent change | Standard Error 2.55 |
| R5 EvoMab Q2W | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | 6.23 percent change | Standard Error 1.1 |
| R5 EvoMab QM | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | 7.72 percent change | Standard Error 1.8 |
| R40 PBO Q2W | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | -0.60 percent change | Standard Error 1.56 |
| R40 PBO QM | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | -0.40 percent change | Standard Error 1.81 |
| R40 EvoMab Q2W | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | 4.86 percent change | Standard Error 1.12 |
| R40 EvoMab QM | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | 6.35 percent change | Standard Error 1.26 |
| S40 PBO Q2W | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | 0.13 percent change | Standard Error 2.75 |
| S40 PBO QM | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | -2.14 percent change | Standard Error 2.72 |
| S40 EvoMab Q2W | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | 10.35 percent change | Standard Error 2.26 |
| S40 EvoMab QM | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | 6.71 percent change | Standard Error 2.25 |
p-value: 0.03495% CI: [2.91, 10.15]Repeated measures linear effects model
p-value: 0.01795% CI: [3.43, 12.79]Repeated measures linear effects model
p-value: 0.00195% CI: [3, 10.34]Repeated measures linear effects model
p-value: 0.00695% CI: [3.93, 13.22]Repeated measures linear effects model
p-value: 0.8595% CI: [-0.19, 8.09]Repeated measures linear effects model
p-value: <0.00195% CI: [4.68, 13.58]Repeated measures linear effects model
p-value: 0.00395% CI: [3.51, 11.64]Repeated measures linear effects model
p-value: 0.00395% CI: [3.86, 12.84]Repeated measures linear effects model
p-value: <0.00195% CI: [1.68, 9.04]Repeated measures linear effects model
p-value: 0.0195% CI: [2.51, 14.8]Repeated measures linear effects model
p-value: 0.01395% CI: [1.69, 9.23]Repeated measures linear effects model
p-value: 0.00295% CI: [2.4, 11.1]Repeated measures linear effects model
p-value: <0.00195% CI: [5.13, 15.32]Repeated measures linear effects model
p-value: <0.00195% CI: [4.73, 12.97]Repeated measures linear effects model
Secondary
Percent Change From Baseline in HDL-C at Week 12
Time frame: Baseline and Week 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| A10 PBO Q2W | Percent Change From Baseline in HDL-C at Week 12 | 0.22 percent change | Standard Error 1.72 |
| A10 PBO QM | Percent Change From Baseline in HDL-C at Week 12 | 0.01 percent change | Standard Error 2.02 |
| A10 EZE (Q2W) | Percent Change From Baseline in HDL-C at Week 12 | -1.76 percent change | Standard Error 1.78 |
| A10 EZE (QM) | Percent Change From Baseline in HDL-C at Week 12 | -0.40 percent change | Standard Error 1.99 |
| A10 EvoMab Q2W | Percent Change From Baseline in HDL-C at Week 12 | 7.04 percent change | Standard Error 1.23 |
| A10 EvoMab QM | Percent Change From Baseline in HDL-C at Week 12 | 7.88 percent change | Standard Error 1.42 |
| A80 PBO Q2W | Percent Change From Baseline in HDL-C at Week 12 | 5.02 percent change | Standard Error 1.88 |
| A80 PBO QM | Percent Change From Baseline in HDL-C at Week 12 | 0.30 percent change | Standard Error 2.01 |
| A80 EZE (Q2W) | Percent Change From Baseline in HDL-C at Week 12 | 0.62 percent change | Standard Error 1.83 |
| A80 EZE (QM) | Percent Change From Baseline in HDL-C at Week 12 | 0.21 percent change | Standard Error 2.01 |
| A80 EvoMab Q2W | Percent Change From Baseline in HDL-C at Week 12 | 9.09 percent change | Standard Error 1.29 |
| A80 EvoMab QM | Percent Change From Baseline in HDL-C at Week 12 | 7.36 percent change | Standard Error 1.43 |
| R5 PBO Q2W | Percent Change From Baseline in HDL-C at Week 12 | 2.87 percent change | Standard Error 1.87 |
| R5 PBO QM | Percent Change From Baseline in HDL-C at Week 12 | -0.16 percent change | Standard Error 2.64 |
| R5 EvoMab Q2W | Percent Change From Baseline in HDL-C at Week 12 | 6.07 percent change | Standard Error 1.35 |
| R5 EvoMab QM | Percent Change From Baseline in HDL-C at Week 12 | 7.18 percent change | Standard Error 1.87 |
| R40 PBO Q2W | Percent Change From Baseline in HDL-C at Week 12 | -0.39 percent change | Standard Error 1.86 |
| R40 PBO QM | Percent Change From Baseline in HDL-C at Week 12 | 0.73 percent change | Standard Error 1.98 |
| R40 EvoMab Q2W | Percent Change From Baseline in HDL-C at Week 12 | 4.65 percent change | Standard Error 1.34 |
| R40 EvoMab QM | Percent Change From Baseline in HDL-C at Week 12 | 5.57 percent change | Standard Error 1.37 |
| S40 PBO Q2W | Percent Change From Baseline in HDL-C at Week 12 | 1.14 percent change | Standard Error 2.96 |
| S40 PBO QM | Percent Change From Baseline in HDL-C at Week 12 | -2.65 percent change | Standard Error 2.87 |
| S40 EvoMab Q2W | Percent Change From Baseline in HDL-C at Week 12 | 10.92 percent change | Standard Error 2.38 |
| S40 EvoMab QM | Percent Change From Baseline in HDL-C at Week 12 | 6.41 percent change | Standard Error 2.34 |
p-value: 0.03495% CI: [2.66, 10.99]Repeated measures linear effects model
p-value: 0.01795% CI: [3.01, 12.73]Repeated measures linear effects model
p-value: 0.00195% CI: [4.58, 13.03]Repeated measures linear effects model
p-value: 0.00695% CI: [3.46, 13.11]Repeated measures linear effects model
p-value: 0.8595% CI: [-0.42, 8.57]Repeated measures linear effects model
p-value: <0.00195% CI: [2.22, 11.89]Repeated measures linear effects model
p-value: 0.00395% CI: [4.07, 12.87]Repeated measures linear effects model
p-value: 0.00395% CI: [2.29, 11.99]Repeated measures linear effects model
p-value: <0.00195% CI: [-1.33, 7.73]Repeated measures linear effects model
p-value: 0.0195% CI: [0.97, 13.72]Repeated measures linear effects model
p-value: 0.01395% CI: [0.52, 9.56]Repeated measures linear effects model
p-value: 0.00295% CI: [0.07, 9.6]Repeated measures linear effects model
p-value: <0.00195% CI: [4.05, 15.51]Repeated measures linear effects model
p-value: <0.00195% CI: [4.4, 13.72]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| A10 PBO Q2W | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | 6.07 percent change | Standard Error 2.86 |
| A10 PBO QM | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | -0.77 percent change | Standard Error 3.28 |
| A10 EZE (Q2W) | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | 1.44 percent change | Standard Error 3.02 |
| A10 EZE (QM) | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | 6.85 percent change | Standard Error 3.29 |
| A10 EvoMab Q2W | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | -26.01 percent change | Standard Error 2.08 |
| A10 EvoMab QM | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | -22.64 percent change | Standard Error 2.27 |
| A80 PBO Q2W | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | -3.45 percent change | Standard Error 2.99 |
| A80 PBO QM | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | 1.51 percent change | Standard Error 3.35 |
| A80 EZE (Q2W) | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | 8.05 percent change | Standard Error 2.94 |
| A80 EZE (QM) | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | 9.96 percent change | Standard Error 3.4 |
| A80 EvoMab Q2W | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | -23.97 percent change | Standard Error 2.1 |
| A80 EvoMab QM | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | -27.46 percent change | Standard Error 2.39 |
| R5 PBO Q2W | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | 11.41 percent change | Standard Error 3 |
| R5 PBO QM | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | 3.65 percent change | Standard Error 3.56 |
| R5 EvoMab Q2W | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | -24.26 percent change | Standard Error 2.21 |
| R5 EvoMab QM | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | -23.16 percent change | Standard Error 2.5 |
| R40 PBO Q2W | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | 8.59 percent change | Standard Error 2.98 |
| R40 PBO QM | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | 6.26 percent change | Standard Error 3.59 |
| R40 EvoMab Q2W | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | -24.96 percent change | Standard Error 2.12 |
| R40 EvoMab QM | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | -25.93 percent change | Standard Error 2.46 |
| S40 PBO Q2W | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | -10.57 percent change | Standard Error 4.49 |
| S40 PBO QM | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | -4.99 percent change | Standard Error 5.37 |
| S40 EvoMab Q2W | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | -38.64 percent change | Standard Error 3.92 |
| S40 EvoMab QM | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | -32.16 percent change | Standard Error 4.5 |
p-value: <0.00195% CI: [-39.06, -25.11]Repeated measures linear effects model
p-value: <0.00195% CI: [-29.7, -14.03]Repeated measures linear effects model
p-value: <0.00195% CI: [-34.53, -20.38]Repeated measures linear effects model
p-value: <0.00195% CI: [-37.36, -21.62]Repeated measures linear effects model
p-value: <0.00195% CI: [-27.71, -13.33]Repeated measures linear effects model
p-value: <0.00195% CI: [-37.01, -20.92]Repeated measures linear effects model
p-value: <0.00195% CI: [-39.11, -24.93]Repeated measures linear effects model
p-value: <0.00195% CI: [-45.61, -29.23]Repeated measures linear effects model
p-value: <0.00195% CI: [-42.94, -28.38]Repeated measures linear effects model
p-value: <0.00195% CI: [-35.36, -18.27]Repeated measures linear effects model
p-value: <0.00195% CI: [-40.74, -26.37]Repeated measures linear effects model
p-value: <0.00195% CI: [-40.8, -23.58]Repeated measures linear effects model
p-value: <0.00195% CI: [-34.91, -21.23]Repeated measures linear effects model
p-value: <0.00195% CI: [-34.59, -19.73]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Lipoprotein(a) at Week 12
Time frame: Baseline and Week 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| A10 PBO Q2W | Percent Change From Baseline in Lipoprotein(a) at Week 12 | 7.34 percent change | Standard Error 3.13 |
| A10 PBO QM | Percent Change From Baseline in Lipoprotein(a) at Week 12 | -0.43 percent change | Standard Error 3.38 |
| A10 EZE (Q2W) | Percent Change From Baseline in Lipoprotein(a) at Week 12 | 3.29 percent change | Standard Error 3.28 |
| A10 EZE (QM) | Percent Change From Baseline in Lipoprotein(a) at Week 12 | 7.18 percent change | Standard Error 3.38 |
| A10 EvoMab Q2W | Percent Change From Baseline in Lipoprotein(a) at Week 12 | -25.87 percent change | Standard Error 2.26 |
| A10 EvoMab QM | Percent Change From Baseline in Lipoprotein(a) at Week 12 | -20.25 percent change | Standard Error 2.36 |
| A80 PBO Q2W | Percent Change From Baseline in Lipoprotein(a) at Week 12 | -2.23 percent change | Standard Error 3.35 |
| A80 PBO QM | Percent Change From Baseline in Lipoprotein(a) at Week 12 | 3.41 percent change | Standard Error 3.54 |
| A80 EZE (Q2W) | Percent Change From Baseline in Lipoprotein(a) at Week 12 | 8.01 percent change | Standard Error 3.26 |
| A80 EZE (QM) | Percent Change From Baseline in Lipoprotein(a) at Week 12 | 10.20 percent change | Standard Error 3.57 |
| A80 EvoMab Q2W | Percent Change From Baseline in Lipoprotein(a) at Week 12 | -24.61 percent change | Standard Error 2.31 |
| A80 EvoMab QM | Percent Change From Baseline in Lipoprotein(a) at Week 12 | -24.68 percent change | Standard Error 2.53 |
| R5 PBO Q2W | Percent Change From Baseline in Lipoprotein(a) at Week 12 | 11.40 percent change | Standard Error 3.37 |
| R5 PBO QM | Percent Change From Baseline in Lipoprotein(a) at Week 12 | 4.49 percent change | Standard Error 3.68 |
| R5 EvoMab Q2W | Percent Change From Baseline in Lipoprotein(a) at Week 12 | -25.09 percent change | Standard Error 2.47 |
| R5 EvoMab QM | Percent Change From Baseline in Lipoprotein(a) at Week 12 | -20.85 percent change | Standard Error 2.59 |
| R40 PBO Q2W | Percent Change From Baseline in Lipoprotein(a) at Week 12 | 10.38 percent change | Standard Error 3.09 |
| R40 PBO QM | Percent Change From Baseline in Lipoprotein(a) at Week 12 | 10.21 percent change | Standard Error 4.36 |
| R40 EvoMab Q2W | Percent Change From Baseline in Lipoprotein(a) at Week 12 | -26.11 percent change | Standard Error 2.21 |
| R40 EvoMab QM | Percent Change From Baseline in Lipoprotein(a) at Week 12 | -21.97 percent change | Standard Error 2.97 |
| S40 PBO Q2W | Percent Change From Baseline in Lipoprotein(a) at Week 12 | -6.81 percent change | Standard Error 4.57 |
| S40 PBO QM | Percent Change From Baseline in Lipoprotein(a) at Week 12 | -1.06 percent change | Standard Error 5.67 |
| S40 EvoMab Q2W | Percent Change From Baseline in Lipoprotein(a) at Week 12 | -38.06 percent change | Standard Error 3.96 |
| S40 EvoMab QM | Percent Change From Baseline in Lipoprotein(a) at Week 12 | -29.23 percent change | Standard Error 4.68 |
p-value: <0.00195% CI: [-40.81, -25.6]Repeated measures linear effects model
p-value: <0.00195% CI: [-27.92, -11.72]Repeated measures linear effects model
p-value: <0.00195% CI: [-36.87, -21.44]Repeated measures linear effects model
p-value: <0.00195% CI: [-35.56, -19.32]Repeated measures linear effects model
p-value: <0.00195% CI: [-30.39, -14.36]Repeated measures linear effects model
p-value: <0.00195% CI: [-36.62, -19.58]Repeated measures linear effects model
p-value: <0.00195% CI: [-40.46, -24.78]Repeated measures linear effects model
p-value: <0.00195% CI: [-43.52, -26.25]Repeated measures linear effects model
p-value: <0.00195% CI: [-44.69, -28.3]Repeated measures linear effects model
p-value: <0.00195% CI: [-34.19, -16.49]Repeated measures linear effects model
p-value: <0.00195% CI: [-43.95, -29.02]Repeated measures linear effects model
p-value: <0.00195% CI: [-42.61, -21.74]Repeated measures linear effects model
p-value: <0.00195% CI: [-38.4, -24.1]Repeated measures linear effects model
p-value: <0.00195% CI: [-36.79, -19.55]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Non-HDL-C at Week 12
Time frame: Baseline and Week 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| A10 PBO Q2W | Percent Change From Baseline in Non-HDL-C at Week 12 | 8.25 percent change | Standard Error 2.32 |
| A10 PBO QM | Percent Change From Baseline in Non-HDL-C at Week 12 | 2.43 percent change | Standard Error 2.69 |
| A10 EZE (Q2W) | Percent Change From Baseline in Non-HDL-C at Week 12 | -18.27 percent change | Standard Error 2.4 |
| A10 EZE (QM) | Percent Change From Baseline in Non-HDL-C at Week 12 | -14.78 percent change | Standard Error 2.65 |
| A10 EvoMab Q2W | Percent Change From Baseline in Non-HDL-C at Week 12 | -53.39 percent change | Standard Error 1.66 |
| A10 EvoMab QM | Percent Change From Baseline in Non-HDL-C at Week 12 | -52.20 percent change | Standard Error 1.9 |
| A80 PBO Q2W | Percent Change From Baseline in Non-HDL-C at Week 12 | 11.79 percent change | Standard Error 3.87 |
| A80 PBO QM | Percent Change From Baseline in Non-HDL-C at Week 12 | 9.95 percent change | Standard Error 3.51 |
| A80 EZE (Q2W) | Percent Change From Baseline in Non-HDL-C at Week 12 | -14.34 percent change | Standard Error 3.75 |
| A80 EZE (QM) | Percent Change From Baseline in Non-HDL-C at Week 12 | -17.26 percent change | Standard Error 3.52 |
| A80 EvoMab Q2W | Percent Change From Baseline in Non-HDL-C at Week 12 | -54.84 percent change | Standard Error 2.66 |
| A80 EvoMab QM | Percent Change From Baseline in Non-HDL-C at Week 12 | -50.05 percent change | Standard Error 2.5 |
| R5 PBO Q2W | Percent Change From Baseline in Non-HDL-C at Week 12 | 7.92 percent change | Standard Error 2.4 |
| R5 PBO QM | Percent Change From Baseline in Non-HDL-C at Week 12 | 5.85 percent change | Standard Error 2.42 |
| R5 EvoMab Q2W | Percent Change From Baseline in Non-HDL-C at Week 12 | -52.04 percent change | Standard Error 1.74 |
| R5 EvoMab QM | Percent Change From Baseline in Non-HDL-C at Week 12 | -51.57 percent change | Standard Error 1.72 |
| R40 PBO Q2W | Percent Change From Baseline in Non-HDL-C at Week 12 | 8.61 percent change | Standard Error 3.04 |
| R40 PBO QM | Percent Change From Baseline in Non-HDL-C at Week 12 | 3.35 percent change | Standard Error 3.53 |
| R40 EvoMab Q2W | Percent Change From Baseline in Non-HDL-C at Week 12 | -50.97 percent change | Standard Error 2.18 |
| R40 EvoMab QM | Percent Change From Baseline in Non-HDL-C at Week 12 | -46.42 percent change | Standard Error 2.45 |
| S40 PBO Q2W | Percent Change From Baseline in Non-HDL-C at Week 12 | 1.89 percent change | Standard Error 3.38 |
| S40 PBO QM | Percent Change From Baseline in Non-HDL-C at Week 12 | 5.66 percent change | Standard Error 4.53 |
| S40 EvoMab Q2W | Percent Change From Baseline in Non-HDL-C at Week 12 | -59.02 percent change | Standard Error 2.87 |
| S40 EvoMab QM | Percent Change From Baseline in Non-HDL-C at Week 12 | -50.96 percent change | Standard Error 3.6 |
p-value: <0.00195% CI: [-67.25, -56.03]Repeated measures linear effects model
p-value: <0.00195% CI: [-61.4, -48.46]Repeated measures linear effects model
p-value: <0.00195% CI: [-40.79, -29.44]Repeated measures linear effects model
p-value: <0.00195% CI: [-44.15, -31.3]Repeated measures linear effects model
p-value: <0.00195% CI: [-75.88, -57.39]Repeated measures linear effects model
p-value: <0.00195% CI: [-68.49, -51.52]Repeated measures linear effects model
p-value: <0.00195% CI: [-49.55, -31.47]Repeated measures linear effects model
p-value: <0.00195% CI: [-41.3, -24.28]Repeated measures linear effects model
p-value: <0.00195% CI: [-65.78, -54.13]Repeated measures linear effects model
p-value: <0.00195% CI: [-63.27, -51.57]Repeated measures linear effects model
p-value: <0.00195% CI: [-66.95, -52.21]Repeated measures linear effects model
p-value: <0.00195% CI: [-58.26, -41.27]Repeated measures linear effects model
p-value: <0.00195% CI: [-66.57, -55.24]Repeated measures linear effects model
p-value: <0.00195% CI: [-64.63, -48.62]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| A10 PBO Q2W | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | 6.80 percent change | Standard Error 2.07 |
| A10 PBO QM | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | 1.28 percent change | Standard Error 2.44 |
| A10 EZE (Q2W) | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | -20.71 percent change | Standard Error 2.15 |
| A10 EZE (QM) | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | -16.56 percent change | Standard Error 2.41 |
| A10 EvoMab Q2W | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | -53.48 percent change | Standard Error 1.48 |
| A10 EvoMab QM | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | -56.09 percent change | Standard Error 1.71 |
| A80 PBO Q2W | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | 10.74 percent change | Standard Error 3.59 |
| A80 PBO QM | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | 8.45 percent change | Standard Error 3.13 |
| A80 EZE (Q2W) | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | -16.19 percent change | Standard Error 3.49 |
| A80 EZE (QM) | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | -18.79 percent change | Standard Error 3.16 |
| A80 EvoMab Q2W | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | -54.44 percent change | Standard Error 2.49 |
| A80 EvoMab QM | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | -56.31 percent change | Standard Error 2.23 |
| R5 PBO Q2W | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | 7.02 percent change | Standard Error 2.11 |
| R5 PBO QM | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | 3.73 percent change | Standard Error 2.32 |
| R5 EvoMab Q2W | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | -52.59 percent change | Standard Error 1.54 |
| R5 EvoMab QM | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | -55.47 percent change | Standard Error 1.64 |
| R40 PBO Q2W | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | 6.19 percent change | Standard Error 2.61 |
| R40 PBO QM | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | 1.58 percent change | Standard Error 2.9 |
| R40 EvoMab Q2W | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | -52.08 percent change | Standard Error 1.88 |
| R40 EvoMab QM | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | -55.72 percent change | Standard Error 2.01 |
| S40 PBO Q2W | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | 0.74 percent change | Standard Error 3.23 |
| S40 PBO QM | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | 6.81 percent change | Standard Error 4.35 |
| S40 EvoMab Q2W | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | -59.33 percent change | Standard Error 2.79 |
| S40 EvoMab QM | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12 | -56.01 percent change | Standard Error 3.49 |
p-value: <0.00195% CI: [-65.29, -55.27]Repeated measures linear effects model
p-value: <0.00195% CI: [-63.23, -51.51]Repeated measures linear effects model
p-value: <0.00195% CI: [-37.84, -27.7]Repeated measures linear effects model
p-value: <0.00195% CI: [-45.34, -33.71]Repeated measures linear effects model
p-value: <0.00195% CI: [-73.78, -56.56]Repeated measures linear effects model
p-value: <0.00195% CI: [-72.32, -57.19]Repeated measures linear effects model
p-value: <0.00195% CI: [-46.68, -29.81]Repeated measures linear effects model
p-value: <0.00195% CI: [-45.15, -29.9]Repeated measures linear effects model
p-value: <0.00195% CI: [-64.73, -54.48]Repeated measures linear effects model
p-value: <0.00195% CI: [-64.8, -53.6]Repeated measures linear effects model
p-value: <0.00195% CI: [-64.6, -51.94]Repeated measures linear effects model
p-value: <0.00195% CI: [-64.29, -50.32]Repeated measures linear effects model
p-value: <0.00195% CI: [-65.18, -54.94]Repeated measures linear effects model
p-value: <0.00195% CI: [-70.22, -55.42]Repeated measures linear effects model
Secondary
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| A10 PBO Q2W | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | 5.96 percent change | Standard Error 1.76 |
| A10 PBO QM | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | 2.24 percent change | Standard Error 2.11 |
| A10 EZE (Q2W) | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | -14.39 percent change | Standard Error 1.83 |
| A10 EZE (QM) | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | -10.86 percent change | Standard Error 2.08 |
| A10 EvoMab Q2W | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | -40.44 percent change | Standard Error 1.26 |
| A10 EvoMab QM | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | -42.45 percent change | Standard Error 1.48 |
| A80 PBO Q2W | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | 4.26 percent change | Standard Error 2.59 |
| A80 PBO QM | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | 6.42 percent change | Standard Error 2.34 |
| A80 EZE (Q2W) | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | -11.92 percent change | Standard Error 2.52 |
| A80 EZE (QM) | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | -12.25 percent change | Standard Error 2.35 |
| A80 EvoMab Q2W | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | -40.22 percent change | Standard Error 1.8 |
| A80 EvoMab QM | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | -40.43 percent change | Standard Error 1.66 |
| R5 PBO Q2W | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | 5.41 percent change | Standard Error 1.96 |
| R5 PBO QM | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | 5.02 percent change | Standard Error 2.25 |
| R5 EvoMab Q2W | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | -39.33 percent change | Standard Error 1.43 |
| R5 EvoMab QM | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | -42.00 percent change | Standard Error 1.59 |
| R40 PBO Q2W | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | 4.55 percent change | Standard Error 1.98 |
| R40 PBO QM | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | 1.71 percent change | Standard Error 2.36 |
| R40 EvoMab Q2W | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | -36.04 percent change | Standard Error 1.42 |
| R40 EvoMab QM | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | -38.62 percent change | Standard Error 1.64 |
| S40 PBO Q2W | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | -0.14 percent change | Standard Error 2.79 |
| S40 PBO QM | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | 5.45 percent change | Standard Error 3.5 |
| S40 EvoMab Q2W | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | -47.20 percent change | Standard Error 2.37 |
| S40 EvoMab QM | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | -43.17 percent change | Standard Error 2.85 |
p-value: <0.00195% CI: [-50.66, -42.15]Repeated measures linear effects model
p-value: <0.00195% CI: [-49.75, -39.63]Repeated measures linear effects model
p-value: <0.00195% CI: [-30.36, -21.75]Repeated measures linear effects model
p-value: <0.00195% CI: [-36.61, -26.57]Repeated measures linear effects model
p-value: <0.00195% CI: [-50.69, -38.27]Repeated measures linear effects model
p-value: <0.00195% CI: [-52.48, -41.21]Repeated measures linear effects model
p-value: <0.00195% CI: [-34.39, -22.21]Repeated measures linear effects model
p-value: <0.00195% CI: [-33.86, -22.5]Repeated measures linear effects model
p-value: <0.00195% CI: [-49.5, -39.97]Repeated measures linear effects model
p-value: <0.00195% CI: [-52.46, -41.57]Repeated measures linear effects model
p-value: <0.00195% CI: [-45.38, -35.79]Repeated measures linear effects model
p-value: <0.00195% CI: [-46, -34.66]Repeated measures linear effects model
p-value: <0.00195% CI: [-51.76, -42.35]Repeated measures linear effects model
p-value: <0.00195% CI: [-54.27, -42.98]Repeated measures linear effects model
Secondary
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12
Time frame: Baseline and Week 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| A10 PBO Q2W | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | 6.09 percent change | Standard Error 2.02 |
| A10 PBO QM | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | 2.80 percent change | Standard Error 2.31 |
| A10 EZE (Q2W) | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | -12.14 percent change | Standard Error 2.1 |
| A10 EZE (QM) | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | -9.85 percent change | Standard Error 2.28 |
| A10 EvoMab Q2W | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | -40.74 percent change | Standard Error 1.45 |
| A10 EvoMab QM | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | -40.07 percent change | Standard Error 1.63 |
| A80 PBO Q2W | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | 4.31 percent change | Standard Error 2.75 |
| A80 PBO QM | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | 6.18 percent change | Standard Error 2.73 |
| A80 EZE (Q2W) | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | -10.53 percent change | Standard Error 2.66 |
| A80 EZE (QM) | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | -11.06 percent change | Standard Error 2.73 |
| A80 EvoMab Q2W | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | -40.79 percent change | Standard Error 1.89 |
| A80 EvoMab QM | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | -36.25 percent change | Standard Error 1.94 |
| R5 PBO Q2W | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | 4.68 percent change | Standard Error 2.28 |
| R5 PBO QM | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | 6.07 percent change | Standard Error 2.36 |
| R5 EvoMab Q2W | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | -38.57 percent change | Standard Error 1.64 |
| R5 EvoMab QM | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | -39.26 percent change | Standard Error 1.68 |
| R40 PBO Q2W | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | 5.96 percent change | Standard Error 2.28 |
| R40 PBO QM | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | 2.69 percent change | Standard Error 2.8 |
| R40 EvoMab Q2W | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | -35.17 percent change | Standard Error 1.63 |
| R40 EvoMab QM | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | -32.30 percent change | Standard Error 1.94 |
| S40 PBO Q2W | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | -0.20 percent change | Standard Error 2.81 |
| S40 PBO QM | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | 5.13 percent change | Standard Error 3.62 |
| S40 EvoMab Q2W | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | -47.24 percent change | Standard Error 2.38 |
| S40 EvoMab QM | Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 | -39.47 percent change | Standard Error 2.92 |
p-value: <0.00195% CI: [-51.73, -41.94]Repeated measures linear effects model
p-value: <0.00195% CI: [-48.43, -37.3]Repeated measures linear effects model
p-value: <0.00195% CI: [-33.56, -23.65]Repeated measures linear effects model
p-value: <0.00195% CI: [-35.74, -24.7]Repeated measures linear effects model
p-value: <0.00195% CI: [-51.66, -38.54]Repeated measures linear effects model
p-value: <0.00195% CI: [-49.01, -35.85]Repeated measures linear effects model
p-value: <0.00195% CI: [-36.68, -23.84]Repeated measures linear effects model
p-value: <0.00195% CI: [-31.79, -18.59]Repeated measures linear effects model
p-value: <0.00195% CI: [-48.77, -37.74]Repeated measures linear effects model
p-value: <0.00195% CI: [-51.04, -39.61]Repeated measures linear effects model
p-value: <0.00195% CI: [-46.65, -35.61]Repeated measures linear effects model
p-value: <0.00195% CI: [-41.72, -28.25]Repeated measures linear effects model
p-value: <0.00195% CI: [-51.83, -42.25]Repeated measures linear effects model
p-value: <0.00195% CI: [-50.67, -38.54]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| A10 PBO Q2W | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | 6.49 percent change | Standard Error 3.94 |
| A10 PBO QM | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | 9.17 percent change | Standard Error 4.41 |
| A10 EZE (Q2W) | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | -3.16 percent change | Standard Error 4.1 |
| A10 EZE (QM) | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | 1.57 percent change | Standard Error 4.35 |
| A10 EvoMab Q2W | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | -5.61 percent change | Standard Error 2.81 |
| A10 EvoMab QM | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | -13.38 percent change | Standard Error 3.08 |
| A80 PBO Q2W | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | 6.16 percent change | Standard Error 4.02 |
| A80 PBO QM | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | 8.05 percent change | Standard Error 4.35 |
| A80 EZE (Q2W) | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | -8.10 percent change | Standard Error 3.92 |
| A80 EZE (QM) | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | -4.86 percent change | Standard Error 4.39 |
| A80 EvoMab Q2W | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | -9.27 percent change | Standard Error 2.8 |
| A80 EvoMab QM | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | -6.36 percent change | Standard Error 3.11 |
| R5 PBO Q2W | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | 12.43 percent change | Standard Error 4.19 |
| R5 PBO QM | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | 12.26 percent change | Standard Error 4.67 |
| R5 EvoMab Q2W | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | -10.28 percent change | Standard Error 3.04 |
| R5 EvoMab QM | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | -7.26 percent change | Standard Error 3.29 |
| R40 PBO Q2W | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | 8.44 percent change | Standard Error 3.76 |
| R40 PBO QM | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | 10.75 percent change | Standard Error 3.98 |
| R40 EvoMab Q2W | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | -9.15 percent change | Standard Error 2.7 |
| R40 EvoMab QM | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | -15.43 percent change | Standard Error 2.77 |
| S40 PBO Q2W | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | 9.29 percent change | Standard Error 6.97 |
| S40 PBO QM | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | 13.78 percent change | Standard Error 7.44 |
| S40 EvoMab Q2W | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | -11.67 percent change | Standard Error 5.97 |
| S40 EvoMab QM | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | -15.93 percent change | Standard Error 6.15 |
p-value: 0.295% CI: [-21.63, -2.58]Repeated measures linear effects model
p-value: 0.00395% CI: [-33.13, -11.97]Repeated measures linear effects model
p-value: 195% CI: [-12.09, 7.19]Repeated measures linear effects model
p-value: 0.05395% CI: [-25.46, -4.44]Repeated measures linear effects model
p-value: 0.07395% CI: [-25.06, -5.79]Repeated measures linear effects model
p-value: 0.02795% CI: [-24.9, -3.92]Repeated measures linear effects model
p-value: 195% CI: [-10.63, 8.3]Repeated measures linear effects model
p-value: 0.6395% CI: [-12.12, 9.11]Repeated measures linear effects model
p-value: <0.00195% CI: [-32.9, -12.54]Repeated measures linear effects model
p-value: 0.00795% CI: [-30.76, -8.28]Repeated measures linear effects model
p-value: 0.00295% CI: [-26.71, -8.46]Repeated measures linear effects model
p-value: <0.00195% CI: [-35.76, -16.59]Repeated measures linear effects model
p-value: <0.00195% CI: [-32.38, -9.55]Repeated measures linear effects model
p-value: <0.00195% CI: [-40.84, -18.57]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Triglycerides at Week 12
Time frame: Baseline and Week 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| A10 PBO Q2W | Percent Change From Baseline in Triglycerides at Week 12 | 8.27 percent change | Standard Error 5.23 |
| A10 PBO QM | Percent Change From Baseline in Triglycerides at Week 12 | 14.35 percent change | Standard Error 5.92 |
| A10 EZE (Q2W) | Percent Change From Baseline in Triglycerides at Week 12 | -0.43 percent change | Standard Error 5.39 |
| A10 EZE (QM) | Percent Change From Baseline in Triglycerides at Week 12 | 4.88 percent change | Standard Error 5.84 |
| A10 EvoMab Q2W | Percent Change From Baseline in Triglycerides at Week 12 | -3.79 percent change | Standard Error 3.72 |
| A10 EvoMab QM | Percent Change From Baseline in Triglycerides at Week 12 | -13.26 percent change | Standard Error 4.17 |
| A80 PBO Q2W | Percent Change From Baseline in Triglycerides at Week 12 | 6.65 percent change | Standard Error 4.45 |
| A80 PBO QM | Percent Change From Baseline in Triglycerides at Week 12 | 8.22 percent change | Standard Error 5.22 |
| A80 EZE (Q2W) | Percent Change From Baseline in Triglycerides at Week 12 | -7.40 percent change | Standard Error 4.32 |
| A80 EZE (QM) | Percent Change From Baseline in Triglycerides at Week 12 | -3.11 percent change | Standard Error 5.23 |
| A80 EvoMab Q2W | Percent Change From Baseline in Triglycerides at Week 12 | -10.07 percent change | Standard Error 3.05 |
| A80 EvoMab QM | Percent Change From Baseline in Triglycerides at Week 12 | -1.10 percent change | Standard Error 3.74 |
| R5 PBO Q2W | Percent Change From Baseline in Triglycerides at Week 12 | 13.57 percent change | Standard Error 5.76 |
| R5 PBO QM | Percent Change From Baseline in Triglycerides at Week 12 | 12.96 percent change | Standard Error 5.32 |
| R5 EvoMab Q2W | Percent Change From Baseline in Triglycerides at Week 12 | -4.46 percent change | Standard Error 4.16 |
| R5 EvoMab QM | Percent Change From Baseline in Triglycerides at Week 12 | -6.88 percent change | Standard Error 3.8 |
| R40 PBO Q2W | Percent Change From Baseline in Triglycerides at Week 12 | 10.97 percent change | Standard Error 4.66 |
| R40 PBO QM | Percent Change From Baseline in Triglycerides at Week 12 | 10.00 percent change | Standard Error 4.38 |
| R40 EvoMab Q2W | Percent Change From Baseline in Triglycerides at Week 12 | -5.58 percent change | Standard Error 3.34 |
| R40 EvoMab QM | Percent Change From Baseline in Triglycerides at Week 12 | -10.51 percent change | Standard Error 3.04 |
| S40 PBO Q2W | Percent Change From Baseline in Triglycerides at Week 12 | 8.07 percent change | Standard Error 6.88 |
| S40 PBO QM | Percent Change From Baseline in Triglycerides at Week 12 | 16.72 percent change | Standard Error 7.88 |
| S40 EvoMab Q2W | Percent Change From Baseline in Triglycerides at Week 12 | -13.71 percent change | Standard Error 5.91 |
| S40 EvoMab QM | Percent Change From Baseline in Triglycerides at Week 12 | -14.65 percent change | Standard Error 6.39 |
p-value: 0.295% CI: [-24.69, 0.57]Repeated measures linear effects model
p-value: 0.00395% CI: [-41.86, -13.35]Repeated measures linear effects model
p-value: 195% CI: [-16.16, 9.43]Repeated measures linear effects model
p-value: 0.05395% CI: [-32.28, -3.99]Repeated measures linear effects model
p-value: 0.07395% CI: [-27.34, -6.1]Repeated measures linear effects model
p-value: 0.02795% CI: [-21.92, 3.29]Repeated measures linear effects model
p-value: 195% CI: [-13.05, 7.72]Repeated measures linear effects model
p-value: 0.6395% CI: [-10.66, 14.69]Repeated measures linear effects model
p-value: <0.00195% CI: [-32.03, -4.04]Repeated measures linear effects model
p-value: 0.00795% CI: [-32.71, -6.96]Repeated measures linear effects model
p-value: 0.00295% CI: [-27.84, -5.26]Repeated measures linear effects model
p-value: <0.00195% CI: [-31.04, -9.98]Repeated measures linear effects model
p-value: <0.00195% CI: [-32.88, -10.68]Repeated measures linear effects model
p-value: <0.00195% CI: [-44.1, -18.62]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| A10 PBO Q2W | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | 6.51 percent change | Standard Error 3.56 |
| A10 PBO QM | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | 9.53 percent change | Standard Error 4.45 |
| A10 EZE (Q2W) | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | -5.35 percent change | Standard Error 3.74 |
| A10 EZE (QM) | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | 1.77 percent change | Standard Error 4.41 |
| A10 EvoMab Q2W | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | -6.85 percent change | Standard Error 2.56 |
| A10 EvoMab QM | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | -11.77 percent change | Standard Error 3.11 |
| A80 PBO Q2W | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | 6.24 percent change | Standard Error 4.03 |
| A80 PBO QM | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | 8.31 percent change | Standard Error 4.26 |
| A80 EZE (Q2W) | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | -8.52 percent change | Standard Error 3.93 |
| A80 EZE (QM) | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | -6.13 percent change | Standard Error 4.31 |
| A80 EvoMab Q2W | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | -8.96 percent change | Standard Error 2.82 |
| A80 EvoMab QM | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | -6.38 percent change | Standard Error 3.05 |
| R5 PBO Q2W | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | 12.86 percent change | Standard Error 3.95 |
| R5 PBO QM | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | 12.54 percent change | Standard Error 4.58 |
| R5 EvoMab Q2W | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | -12.22 percent change | Standard Error 2.86 |
| R5 EvoMab QM | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | -7.25 percent change | Standard Error 3.23 |
| R40 PBO Q2W | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | 7.06 percent change | Standard Error 3.76 |
| R40 PBO QM | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | 8.13 percent change | Standard Error 3.72 |
| R40 EvoMab Q2W | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | -9.09 percent change | Standard Error 2.71 |
| R40 EvoMab QM | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | -15.05 percent change | Standard Error 2.58 |
| S40 PBO Q2W | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | 8.64 percent change | Standard Error 6.01 |
| S40 PBO QM | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | 16.37 percent change | Standard Error 7.15 |
| S40 EvoMab Q2W | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | -14.57 percent change | Standard Error 5.17 |
| S40 EvoMab QM | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12 | -16.50 percent change | Standard Error 5.87 |
p-value: 0.08895% CI: [-21.99, -4.74]Repeated measures linear effects model
p-value: 0.00595% CI: [-31.98, -10.64]Repeated measures linear effects model
p-value: 195% CI: [-10.27, 7.27]Repeated measures linear effects model
p-value: 0.05695% CI: [-24.17, -2.91]Repeated measures linear effects model
p-value: 0.07395% CI: [-24.88, -5.54]Repeated measures linear effects model
p-value: 0.02795% CI: [-24.97, -4.42]Repeated measures linear effects model
p-value: 195% CI: [-9.94, 9.05]Repeated measures linear effects model
p-value: 0.6295% CI: [-10.66, 10.16]Repeated measures linear effects model
p-value: <0.00195% CI: [-34.64, -15.5]Repeated measures linear effects model
p-value: 0.00795% CI: [-30.81, -8.77]Repeated measures linear effects model
p-value: 0.00595% CI: [-25.27, -7.03]Repeated measures linear effects model
p-value: <0.00195% CI: [-32.11, -14.25]Repeated measures linear effects model
p-value: <0.00195% CI: [-33, -13.43]Repeated measures linear effects model
p-value: <0.00195% CI: [-43.6, -22.14]Repeated measures linear effects model
Secondary
Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12
Time frame: Baseline and Week 12
Population: Full analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| A10 PBO Q2W | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 | 8.32 percent change | Standard Error 4 |
| A10 PBO QM | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 | 14.74 percent change | Standard Error 5.91 |
| A10 EZE (Q2W) | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 | -4.61 percent change | Standard Error 4.19 |
| A10 EZE (QM) | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 | 3.45 percent change | Standard Error 5.89 |
| A10 EvoMab Q2W | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 | -6.16 percent change | Standard Error 2.88 |
| A10 EvoMab QM | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 | -11.73 percent change | Standard Error 4.16 |
| A80 PBO Q2W | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 | 6.73 percent change | Standard Error 4.45 |
| A80 PBO QM | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 | 8.54 percent change | Standard Error 5 |
| A80 EZE (Q2W) | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 | -7.92 percent change | Standard Error 4.32 |
| A80 EZE (QM) | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 | -6.00 percent change | Standard Error 5.04 |
| A80 EvoMab Q2W | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 | -9.69 percent change | Standard Error 3.05 |
| A80 EvoMab QM | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 | -1.06 percent change | Standard Error 3.58 |
| R5 PBO Q2W | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 | 13.79 percent change | Standard Error 5.05 |
| R5 PBO QM | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 | 12.47 percent change | Standard Error 5.31 |
| R5 EvoMab Q2W | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 | -8.20 percent change | Standard Error 3.64 |
| R5 EvoMab QM | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 | -6.28 percent change | Standard Error 3.78 |
| R40 PBO Q2W | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 | 10.09 percent change | Standard Error 4.65 |
| R40 PBO QM | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 | 8.59 percent change | Standard Error 4.37 |
| R40 EvoMab Q2W | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 | -6.10 percent change | Standard Error 3.33 |
| R40 EvoMab QM | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 | -9.95 percent change | Standard Error 3.03 |
| S40 PBO Q2W | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 | 7.63 percent change | Standard Error 6.26 |
| S40 PBO QM | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 | 20.97 percent change | Standard Error 7.53 |
| S40 EvoMab Q2W | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 | -14.83 percent change | Standard Error 5.3 |
| S40 EvoMab QM | Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12 | -15.86 percent change | Standard Error 6.09 |
p-value: 0.08895% CI: [-24.16, -4.78]Repeated measures linear effects model
p-value: 0.00595% CI: [-40.71, -12.24]Repeated measures linear effects model
p-value: 195% CI: [-11.41, 8.32]Repeated measures linear effects model
p-value: 0.05695% CI: [-29.4, -0.97]Repeated measures linear effects model
p-value: 0.07395% CI: [-27.05, -5.8]Repeated measures linear effects model
p-value: 0.02795% CI: [-21.68, 2.48]Repeated measures linear effects model
p-value: 195% CI: [-12.16, 8.61]Repeated measures linear effects model
p-value: 0.6295% CI: [-7.25, 17.14]Repeated measures linear effects model
p-value: <0.00195% CI: [-34.24, -9.73]Repeated measures linear effects model
p-value: 0.00795% CI: [-31.6, -5.9]Repeated measures linear effects model
p-value: 0.00595% CI: [-27.46, -4.92]Repeated measures linear effects model
p-value: <0.00195% CI: [-29.04, -8.05]Repeated measures linear effects model
p-value: <0.00195% CI: [-33.09, -11.81]Repeated measures linear effects model
p-value: <0.00195% CI: [-48.96, -24.7]Repeated measures linear effects model