A Phase 3 interventional study of Evolocumab in Dyslipidemia, sponsored by Amgen. Terminated at 85 sites in 7 countries. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by Amgen · Phase 3, Interventional, and Treatment
This is a multicenter, open-label extension (OLE) study designed to assess the extended long-term safety of evolocumab in subjects who have completed the FOURIER trial (Study 20110118). Approximately 1600 subjects will be enrolled in this study. This study will continue for 260 weeks (approximately 5 years).
This is a multicenter, open-label extension (OLE) study designed to assess the extended long-term safety of evolocumab in subjects who have completed the FOURIER trial (Study 20110118). FOURIER is a randomized placebo-controlled study of evolocumab, in patients with clinically evident atherosclerotic CVD on stable effective statin therapy. Subjects at sites participating in FOURIER OLE (Study 20160250) who are eligible and have signed the FOURIER OLE informed consent will be enrolled after completion of FOURIER.
The FOURIER OLE study requires laboratory assessments at day 1, week 12, and thereafter approximately every 6 months from day 1; the corresponding blood samples will be processed using a central laboratory.
Upon enrollment in FOURIER OLE study, subjects will receive evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM) according to their preference. Frequency and corresponding dose of administration can be changed at any scheduled time point where evolocumab is supplied to the subject, provided the appropriate supply is available. It is recommended that subjects continue the same background lipid-lowering therapy (LLT), including statin, as taken during FOURIER.
This study will continue for 260 weeks (approximately 5 years). Subjects ending administration of evolocumab should continue study assessments until the end of study. All subjects will be followed and complete procedures/assessments from enrollment through the date of study termination unless the subject has withdrawn consent, irrespective of whether the subject is continuing to receive treatment.
All deaths and cardiovascular events of interest will be reviewed by an independent external Clinical Events Committee (CEC), using standardized definitions.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 1,600 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single arm study administering Evolocumab.
Drug: Evolocumab
Subjects will receive Evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.
Also known as: AMG 145
Number of Participants Who Experienced an Adverse Event
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.
Time frame: Up to 5 years
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit
Time frame: Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL
Time frame: Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260
This was an open-label extension of study 20110118 (NCT01764633). Eligible participants were enrolled after the completion of the 20110118 study. 1600 participants were enrolled at 86 centers in Belgium, Germany, Denmark, France, Italy, Portugal, and Sweden from 13 March 2017 to 04 March 2022.
| Milestone | Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study | Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study |
|---|---|---|
| Started | 745 | 855 |
| Completed | 695 | 786 |
| Not completed | 50 | 69 |
| Withdrew: Death | 34 | 50 |
| Withdrew: Lost to follow-up | 5 | 4 |
| Withdrew: Withdrawal by subject | 11 | 15 |
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.
| Participants | Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study | Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event | 686 | 810 |
| Percent Change | Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study | Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study |
|---|---|---|
| Week 12 | -66.32 ± 26.88 | -67.24 ± 25.23 |
| Week 24 | -66.48 ± 27.52 | -66.47 ± 28.11 |
| Week 48 | -62.61 ± 26.60 | -63.45 ± 26.03 |
| Week 72 | -65.58 ± 28.13 | -65.33 ± 28.42 |
| Week 96 | -64.58 ± 27.01 | -63.43 ± 28.80 |
| Week 120 | -64.26 ± 28.31 | -63.10 ± 29.56 |
| Week 144 | -66.79 ± 29.22 | -65.13 ± 31.96 |
| Week 168 | -65.28 ± 27.55 | -63.55 ± 29.60 |
| Week 192 | -65.02 ± 27.93 | -62.46 ± 26.39 |
| Week 216 | -64.92 ± 27.93 | -62.46 ± 28.32 |
| Week 260 | -66.45 ± 29.84 | -64.72 ± 29.50 |
| Percentage of Participants | Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study | Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study |
|---|---|---|
| Baseline in parent study | 0 (0.0 to 0.5) | 0 (0.0 to 0.4) |
| Week 12 | 72.8 (69.4 to 75.9) | 72.5 (69.4 to 75.4) |
| Week 24 | 72.9 (69.5 to 76.0) | 73.4 (70.3 to 76.2) |
| Week 48 | 66.5 (63.0 to 69.9) | 68.0 (64.8 to 71.1) |
| Week 72 | 73.2 (69.8 to 76.3) | 72.3 (69.1 to 75.2) |
| Week 96 | 71.1 (67.6 to 74.3) | 69.2 (65.9 to 72.3) |
| Week 120 | 70.9 (67.5 to 74.2) | 68.6 (65.3 to 71.8) |
| Week 144 | 75.3 (71.2 to 78.9) | 72.2 (68.5 to 75.7) |
| Week 168 | 72.3 (68.8 to 75.6) | 69.3 (65.9 to 72.5) |
| Week 192 | 71.6 (67.9 to 74.9) | 66.3 (62.8 to 69.7) |
| Week 216 | 72.1 (68.6 to 75.4) | 67.3 (63.9 to 70.6) |
| Week 260 | 76.1 (71.6 to 80.2) | 68.8 (64.2 to 73.0) |
Collected over Up to 5 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo in Parent Study | 35/745 (4.7%) | 323/745 (43.4%) | 451/745 (60.5%) |
| Evolocumab in Parent Study | 51/855 (6%) | 410/854 (48%) | 528/854 (61.8%) |
| Event | Placebo in Parent Study | Evolocumab in Parent Study |
|---|---|---|
| Angina pectorisCardiac disorders | 26/745 | 24/854 |
| Cardiac failureCardiac disorders | 17/745 | 27/854 |
| Atrial fibrillationCardiac disorders | 15/745 | 22/854 |
| Acute myocardial infarctionCardiac disorders | 18/745 | 15/854 |
| PneumoniaInfections and infestations | 15/745 | 19/854 |
| Angina unstableCardiac disorders | 15/745 | 13/854 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 8/745 | 15/854 |
| Ischaemic strokeNervous system disorders | 8/745 | 14/854 |
| Peripheral arterial occlusive diseaseVascular disorders | 12/745 | 12/854 |
| SyncopeNervous system disorders | 10/745 | 10/854 |
| Event | Placebo in Parent Study | Evolocumab in Parent Study |
|---|---|---|
| HypertensionVascular disorders | 132/745 | 150/854 |
| NasopharyngitisInfections and infestations | 75/745 | 111/854 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 61/745 | 75/854 |
| Back painMusculoskeletal and connective tissue disorders | 50/745 | 70/854 |
| Diabetes mellitusMetabolism and nutrition disorders | 60/745 | 57/854 |
| MyalgiaMusculoskeletal and connective tissue disorders | 55/745 | 47/854 |
| InfluenzaInfections and infestations | 37/745 | 53/854 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 24/745 | 50/854 |
| Atrial fibrillationCardiac disorders | 37/745 | 49/854 |
| CataractEye disorders | 42/745 | 32/854 |
The Overall Number of Baseline Participants is made up of all of the participants that received study drug.
| Age, Continuous(Years) | Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study | Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study | Total |
|---|---|---|---|
| Mean | 62.7 ± 9.1 | 62.6 ± 8.9 | 62.6 ± 9.0 |
| Sex: Female, Male(Participants) | Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study | Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study | Total |
|---|---|---|---|
| Female | 138 | 151 | 289 |
| Male | 607 | 703 | 1310 |
| Ethnicity (NIH/OMB)(Participants) | Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study | Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study | Total |
|---|---|---|---|
| Hispanic or Latino | 17 | 24 | 41 |
| Not Hispanic or Latino | 728 | 830 | 1558 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study | Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 2 | 2 |
| Black or African American | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 2 | 2 |
| White | 706 | 797 | 1503 |
| Multiple | 0 | 0 | 0 |
| Other | 38 | 53 | 91 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting information: Study protocol, Sap, Icf, Csr
This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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