Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Evolocumab · 37 trials · 22 indications
All deaths and individual components were adjudicated by an independent external clinical events committee (CEC), using standardized definitions. The number of participants who experienced CHD death, MI, or ischemic stroke, whichever occurred first, among participants at high cardiovascular risk without prior MI or stroke and were receiving optimized lipid lowering therapy was analyzed.
All deaths and individual components were adjudicated by an independent external CEC, using standardized definitions. The number of participants who experienced CHD death, MI, ischemic stroke, or any ischemia-driven arterial revascularization, whichever occurred first, among participants at high cardiovascular risk without prior MI or stroke and were receiving optimized lipid lowering therapy was analyzed.
Absolute change from baseline in minimum FCT in a matched segment of artery as determined by OCT. Minimum FCT for a participant is defined as the minimum of all minimum FCT measurements within each individual frame across all frames of that participant. Higher value of FCT indicates a better situation.
Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.)
An adverse event is defined as any untoward medical occurrence in a clinical trial participant, not necessarily having a causal relationship with study treatment. A serious AE is as an AE that met at least 1 of the following criteria: * fatal; * life threatening; * required in-patient hospitalization or prolongation of existing hospitalization; * resulted in persistent or significant disability/incapacity; * congenital anomaly/birth defect; * other medically important serious event. AEs were graded for severity using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; urgent intervention indicated; Grade 5: Death related to AE.
All adverse event summaries for the primary analysis of the primary endpoint (OLE study period only) included all treatment-emergent events reported on the Event electronic case report form (eCRF), including CEC positively reviewed events and disease-related events.
Arterial inflammation was assessed using 18F-fluoro-deoxyglucose positron-emission tomography/computed tomography (18F-FDG PET/CT). Arterial 18F-FDG uptake is correlated with arterial macrophage content and predicts cardiovascular events. Images were analyzed by an experienced radiologist blinded to all patient characteristics. The maximum standardized uptake value was calculated as a time- and dose- corrected tissue radioactivity divided by body weight in the index and the target-to-background ratio (TBR) was calculated from the ratio of the standardized uptake value of the artery compared to mean background venous activity. The average maximum TBR for the most diseased segment (MDS) was calculated from a group of 3 contiguous slices (approximately 1.5 cm), centered on the slice with the highest maximum TBR in the index vessel. The index vessel was defined as the vessel (either the right or left carotid or aorta) with the highest mean TBR at baseline.
Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from interactive voice response system \[IVRS\]), scheduled visit and the interaction of treatment with scheduled visit as covariates. The model uses an unstructured covariance.
For all efficacy endpoints the two dosing regimens (every 2 weeks and every month) for each treatment were pooled for analysis.
Avoidance of apheresis at end of randomized therapy was defined as no apheresis at week 5 and week 6. Aperesis at weeks 5 or 6 was based on LDL-C level at week 4: participants with LDL-C ≥ 100 mg/dL at week 4 received apheresis at week 5 (participants who received apheresis QW before study entry) or week 6 (participants who received apheresis Q2W prior to study entry). If LDL-C was \< 100 mg/dL at week 4, no apheresis was performed at week 5 or week 6, irrespective of assigned treatment group. Participants who ended the study prior to week 6 were considered as not achieving apheresis avoidance.
The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 criteria, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe or medically significant AE, Grade 4 = Life-threatening consequences, and Grade 5 = death related to AE. An adverse device effect was defined as any adverse event related to the use of a medical device (autoinjector/pen or automated mini doser \[AMD\]), including but not limited to, AEs resulting from insufficient or inadequate Instructions for Use, AEs resulting from any malfunction of the device, or AEs resulting from use error or from intentional misuse of the device.
Assessments were performed with the Cambridge Neuropsychological Test Automated Battery (CANTAB), a language-independent battery of computerized tests that is used to assess cognitive function. The Spatial Working Memory (SWM) test assesses the cognitive domain of executive function (high-level thinking and decision making). Patients search for colored tokens hidden inside boxes on the screen by touching them. The critical instruction is that once a token has been found inside a box, there will never be a token hidden inside that box again, so patients must not return to a box where a token has been found. The SWM strategy index of executive function represented the number of times a subject began a search with a different box. The Z score represents the standardized measure of how far an individual subject deviates from the study cohort average at baseline. A higher Z score reflects better performance. The mean change from baseline averaged across all the visits is reported.
The fractional catabolic rate (the percentage of apolipoprotein B-100 in LDL which is replaced, transferred or lost per unit of time) was measured at Baseline and Day 50 over 5 consecutive days using the stable isotope tracer, D3-leucine. LDL particles were isolated from plasma by sequential ultracentrifugation, and isotopic enrichment was determined using gas chromatography-mass spectrometry. Mathematical modelling of the protein enrichment data was used to estimate protein catabolism.
Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. The extent of atherosclerosis was expressed as percent atheroma volume (PAV) in a ≥ 40 mm segment of one targeted (imaged) coronary artery, calculated as the percentage of the total vessel volume occupied by atheroma.
All deaths and potential endpoint events were adjudicated by an independent external Clinical Events Committee (CEC) led by the Thrombolysis in Myocardial Infarction (TIMI) Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date.
Cholesterol was measured by means of ultracentrifugation.
The primary outcome measure for this study was percent change in LDL from baseline after 12 weeks of evolocumab therapy. Serum LDL was measured at baseline and after 12 weeks of evolocumab therapy. This primary endpoint was used in prior phase 2 trials investigating evolocumab in other patient populations. Wilcoxon matched-pairs signed rank test was used for statistical assessment.
The difference, in the percent change in LDL-cholesterol (mg/dL), from baseline to the 25-30 day values.
PET Imaging for Inflammation: Change from baseline in target to background ratio Fluorodeoxyglucose (FDG) PET scans in the myocardium.
LDL-C was quantified using the ultracentrifugation method.
LDL-C was quantified using the ultracentrifugation method.
LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (evolocumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.
Serum concentrations of evolocumab were measured by a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) of the assay was 800 ng/mL.
Serum samples were analyzed by an electrochemiluminescence (ECL)-based immunoassay for anti-evolocumab binding antibodies. Positive samples were subsequently tested in a receptor-ligand binding bioassay for anti-evolocumab neutralizing antibodies
IL-6 expression will be measured in myeloid cells in the aortic tissue specimens using single nucleus RNA sequencing and confirmed by whole tissue ELISA.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo subcutaneous injection once every 2 weeks (Q2W). |
| Evolocumab 140 mg Q2W | EXPERIMENTAL | Participants will receive 140 mg evolocumab by subcutaneous injection Q2W. |
| Evolocumab | EXPERIMENTAL | Participants receive evolocumab subcutaneous injection once every month (QM) for 48 weeks. As prescribed and provided by the investigator, participants will be treated with maximally tolerated statin therapy, not expected to change for the duration of the study participation. |
| Double-Blind Placebo SC QM/Open-Label Evolocumab 420 mg SC QM | EXPERIMENTAL | Double-blind placebo subcutaneous (SC) injection every 4 weeks (QM) for 24 weeks, followed by open-label evolocumab 420 mg SC QM for 24 weeks. |
| Double-Blind Evolocumab 420 mg SC QM/Open-Label Evolocumab 420 mg SC QM | PLACEBO_COMPARATOR | Double-blind evolocumab SC injection QM for 24 weeks, followed by open-label evolocumab 420 mg SC QM for 24 weeks. |
| evolocumab (AMG 145) | EXPERIMENTAL | All subjects are randomized to a single arm and will receive evolocumab 140mg every two weeks (Q2W) or 420mg monthly (QM) according to subject's preference. |
| Evolocumab 420 mg QM | EXPERIMENTAL | Participants received 420 mg evolocumab by subcutaneous injection once a month (QM) for 12 weeks. |
| Atorvastatin (Q2W) | ACTIVE_COMPARATOR | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks. |
| Atorvastatin (QM) | ACTIVE_COMPARATOR | Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks. |
| Evolocumab Q2W + Atorvastatin | EXPERIMENTAL | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks. |
| Evolocumab QM + Atorvastatin | EXPERIMENTAL | Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks. |
| EvoMab 420 mg QM | EXPERIMENTAL | Evolocumab subcutaneous injection QM |
| Ezetimibe (Q2W) | ACTIVE_COMPARATOR | Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for 12 weeks. From week 12 participants received open-label evolocumab 140 mg subcutaneously once every 2 weeks until week 48. |
| Ezetimibe (QM) | ACTIVE_COMPARATOR | Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for 12 weeks. From week 12 participants received open-label evolocumab 420 mg subcutaneously once a month until week 48. |
| Evolocumab Q2W | EXPERIMENTAL | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for 12 weeks. From week 12 participants received open-label evolocumab 140 mg subcutaneously once every 2 weeks until week 48. |
| Evolocumab QM | EXPERIMENTAL | Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for 12 weeks. From week 12 participants received open-label evolocumab 420 mg subcutaneously once a month until week 48. |
| Low Density Lipoprotein Cholesterol (LDL-C) Apheresis | ACTIVE_COMPARATOR | Participants continued apheresis at the same schedule, every week (QW) or every two weeks (Q2W), as prior to study entry, for the first 6 weeks. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24. |
| Atorvastatin | ACTIVE_COMPARATOR | Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks. |
| Evolocumab and Atorvastatin | EXPERIMENTAL | Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks. |
| A5 Placebo Q2W | PLACEBO_COMPARATOR | Participants received atorvastatin 5 mg (A5) once daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. |
| A5 Placebo QM | PLACEBO_COMPARATOR | Participants received atorvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks. |
| A5 Evolocumab Q2W | EXPERIMENTAL | Participants received atorvastatin 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 12 weeks. |
| A5 Evolocumab QM | EXPERIMENTAL | Participants received atorvastatin 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 12 weeks. |
| A20 Placebo Q2W | PLACEBO_COMPARATOR | Participants received atorvastatin 20 mg (A20) once daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks. |
| A20 Placebo QM | OTHER | Participants received atorvastatin 20 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks. |
| A20 Evolocumab Q2W | EXPERIMENTAL | Participants received atorvastatin 20 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 12 weeks. |
| A20 Evolocumab QM | EXPERIMENTAL | Participants received atorvastatin 20 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 12 weeks. |
| Standard of Care | ACTIVE_COMPARATOR | Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product \[all-IP\] period. |
| Evolocumab + Standard of Care | EXPERIMENTAL | Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice. |
| Placebo Q2W | PLACEBO_COMPARATOR | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks. |
| Placebo QM | PLACEBO_COMPARATOR | Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks. |
| A10 PBO Q2W | PLACEBO_COMPARATOR | 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. |
| A10 PBO QM | PLACEBO_COMPARATOR | Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks. |
| A10 EZE (Q2W) | ACTIVE_COMPARATOR | Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once a day for up to 12 weeks. |
| A10 EZE (QM) | ACTIVE_COMPARATOR | Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. |
| A10 EvoMab Q2W | EXPERIMENTAL | Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. |
| A10 EvoMab QM | EXPERIMENTAL | Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks |
| A80 PBO Q2W | PLACEBO_COMPARATOR | Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. |
| A80 PBO QM | PLACEBO_COMPARATOR | Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every month and placebo tablets once a day for up to 12 weeks. |
| A80 EZE (Q2W) | ACTIVE_COMPARATOR | Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks. |
| A80 EZE (QM) | ACTIVE_COMPARATOR | Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks. |
| A80 EvoMab Q2W | EXPERIMENTAL | Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks. |
| A80 EvoMab QM | EXPERIMENTAL | Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks. |
| R5 PBO Q2W | PLACEBO_COMPARATOR | Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks for up to 12 weeks. |
| R5 PBO QM | PLACEBO_COMPARATOR | Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every month for up to 12 weeks. |
| R5 EvoMab Q2W | EXPERIMENTAL | Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. |
| R5 EvoMab QM | EXPERIMENTAL | Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. |
| R40 PBO Q2W | PLACEBO_COMPARATOR | Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks for up to 12 weeks. |
| R40 PBO QM | PLACEBO_COMPARATOR | Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every month for up to 12 weeks. |
| R40 EvoMab Q2W | EXPERIMENTAL | Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. |
| R40 EvoMab QM | EXPERIMENTAL | Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. |
| S40 PBO Q2W | PLACEBO_COMPARATOR | Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks for up to 12 weeks. |
| S40 PBO QM | PLACEBO_COMPARATOR | Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every month for up to 12 weeks. |
| S40 EvoMab Q2W | EXPERIMENTAL | Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks. |
| S40 EvoMab QM | EXPERIMENTAL | Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks. |
| Placebo Q4W | PLACEBO_COMPARATOR | Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks. |
| Evolocumab 70 mg Q2W | EXPERIMENTAL | Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. |
| Evolocumab 280 mg Q4W | EXPERIMENTAL | Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. |
| Evolocumab 420 mg Q4W | EXPERIMENTAL | Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. |
| Part A: Evolocumab | EXPERIMENTAL | Participants received open-label evolocumab 420 mg subcutaneously once a month for 12 weeks. |
| Part B: Evolocumab | EXPERIMENTAL | Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks. |
| Part B: Placebo | PLACEBO_COMPARATOR | Participants received double-blind placebo subcutaneously once a month for 12 weeks. |
| Evolocumab + SOC | EXPERIMENTAL | Participants received evolocumab 420 mg once a month plus standard of care for the first year of the study (SOC-controlled period). At week 52 participants continued treatment with evolocumab 420 mg QM for another 4 years during the all-IP period. |
| Evolocumab 350 mg | EXPERIMENTAL | Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. |
| Evolocumab 420 mg | EXPERIMENTAL | Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. |
| Ezetimibe | ACTIVE_COMPARATOR | Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. |
| Evolocumab + Ezetimibe | EXPERIMENTAL | Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. |
| Evolocumab 280 mg | EXPERIMENTAL | Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. |
| Evolocumab 105 mg Q2W | EXPERIMENTAL | Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. |
| Evolocumab 350 mg Q4W | EXPERIMENTAL | Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Evolocumab | DRUG | Administered subcutaneously using an autoinjector pen. |
| Placebo | DRUG | Administered subcutaneously using an autoinjector pen. |
| Statin therapy | DRUG | high-intensity statin treatment with atorvastatin ≥ 40 mg daily or equivalent as background therapy Investigators will up-titrate statin therapy to the maximally tolerated dose, in accordance with local guidelines, prior to randomization. |
| Placebo to Evolocumab | DRUG | Administered by subcutaneous injection with an automated mini doser |
| Atorvastatin | DRUG | Administered orally once a day |
| Ezetimibe | DRUG | Tablet for oral administration |
| Placebo Ezetimibe | DRUG | Tablet for oral administration |
| Low-density Lipoprotein Cholesterol (LDL-C) Apheresis | PROCEDURE | Participants received apheresis for LDL-C according the their physician's prescription and local custom. |
| Background Statin Therapy | DRUG | Participants were required to be on a stable, high- to moderate-intensity statin background therapy consisting of an effective statin dose, ie, at least atorvastatin 20 mg daily or equivalent, and where locally approved, highly effective statin therapy (defined as at least atorvastatin 40 mg daily or equivalent) was recommended. |
| Placebo to Atorvastatin | DRUG | Administered by mouth |
| Standard of Care | DRUG | Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes |
| Placebo to Ezetimibe | DRUG | Tablet for oral administration |
| Rosuvastatin | DRUG | Administered orally once a day |
| Simvastatin | DRUG | Administered orally once a day |
| Diet Only | OTHER | Diet only, no lipid lowering background drug given |
| Placebos | DRUG | Matching placebo. |
Inclusion criteria: * Age: Adult participants ≥ 50 (men) or ≥ 55 (women) to ˂ 80 years of age (either sex) and meeting lipid criteria. * Lipid Criteria: Low-density lipoprotein cholesterol (LDL-C) ≥ 90 mg/dL (≥ 2.3 mmol/L) or non high-density lipoprotein cholesterol (non-HDL)-C ≥ 120 mg/dL (≥ 3.1 m...
Evolocumab is used for lowering low-density lipoprotein cholesterol (LDL-C) in subjects with hyperlipidemia, dyslipidemia and HIV infection, coronary heart disease (CHD), severe familial hypercholesterolemia, hyperlipidemia and mixed dyslipidemia, coronary artery disease (CAD), and familial hypercholesterolemia. It is being developed by Amgen Inc. for the cardiovascular therapeutic area.
Evolocumab targets PCSK9, a protein that regulates cholesterol levels. It is a PCSK9 inhibitor, which means it blocks the action of PCSK9 to help lower LDL cholesterol. This mechanism is relevant for treating conditions like hyperlipidemia and familial hypercholesterolemia.
Evolocumab is developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. Amgen is conducting clinical trials to evaluate the safety and efficacy of Evolocumab in patients with various lipid disorders.
Evolocumab is in Phase 1 of clinical development, according to the latest data. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in multiple Phase 3 trials, but the overall development phase is listed as Phase 1.
Evolocumab has been studied in several clinical trials, including NCT01953328 in Japanese patients with advanced cardiovascular risk, NCT02189837 in patients with primary hyperlipidemia and mixed dyslipidemia, NCT02624869 in children with familial hypercholesterolemia, and NCT02833844 in participants with HIV and hyperlipidemia or mixed dyslipidemia. These trials have been completed.
Yes, Evolocumab is also known as AMG 145. Clinical trial titles refer to Evolocumab (AMG 145), confirming that these names refer to the same drug. This alternative name is used in studies such as NCT01953328 and NCT02624869.