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CompletedNCT01439880OSLERUpdated Sep 21, 2022Results posted

Open Label Study of Long Term Evaluation Against LDL-C Trial

A Phase 2 interventional study of Evolocumab and Standard of care in Hypercholesterolemia, sponsored by Amgen. Completed at 187 sites in 18 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-09-21.

Sponsored by Amgen · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
1,324
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.

02

Conditions studied

  • Hypercholesterolemia

Keywords

  • High cholesterol
  • Raised cholesterol
  • Cholesterol
  • Elevated Cholesterol
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's enrollment of 1,324 is above the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Complete a qualifying evolocumab (AMG 145) parent study protocol, including: 20101154 (NCT01375777), 20101155 (NCT01380730), 20090158 (NCT01375751), 20090159 (NCT01375764), and 20110231 (NCT01652703)

Exclusion criteria

Exclusion Criteria:

  • Experienced a treatment-related serious adverse event that led to investigational product (IP) discontinuation in the parent study
  • Have an unstable medical condition, in the judgment of the investigator
  • Known sensitivity to any of the products to be administered during dosing
  • Currently enrolled in another investigational device or drug study (excluding evolocumab (AMG 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,324 participants (actual)

Study arms

  • Active comparator
    Standard of Care

    Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 52 participants began treatment with evolocumab 420 mg once a month (QM) for 4 years during the all-investigational product \[all-IP\] period.

    Biological: Evolocumab · Other: Standard of care

  • Experimental
    Evolocumab + SOC

    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.

    Biological: Evolocumab

Interventions

  • BiologicalEvolocumab

    Administered by subcutaneous injection

    Also known as: AMG 145, Repatha

  • OtherStandard of care

    Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes

06

What researchers measure

Primary outcomes

  1. Number of Participants With Adverse Events

    Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.03, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE.

    Time frame: 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; actual median duration of treatment in the All-IP period was 46.9 months.

Secondary outcomes

  1. Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52

    Time frame: Baseline of parent study and extension study weeks 24 and 52

  2. Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52

    Time frame: Baseline of parent study and extension study weeks 24 and 52

  3. Apolipoprotein B Level at Week 24 and Week 52

    Time frame: Baseline of parent study and extension study weeks 24 and 52

  4. Total Cholesterol/HDL-C Ratio at Week 24 and Week 52

    Time frame: Baseline of parent study and extension study weeks 24 and 52

  5. Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52

    Time frame: Baseline of parent study and extension study weeks 24 and 52

07

Results

Posted Jul 10, 2019

Participant flow

This extension study was conducted at 188 centers in 18 countries. Participants were enrolled from one of five eligible phase 2 parent studies: 20101154 (NCT01375777), 20101155 (NCT01380730), 20090158 (NCT01375751), 20090159 (NCT01375764), and 20110231 (NCT01652703). Participants were enrolled from October 2011 to June 2013.

SOC-controlled Period (Year 1)
Participant flow — SOC-controlled Period (Year 1)
MilestoneStandard of CareEvolocumab + SOC
Started442882
Received evolocumab0881
Completed398822
Not completed4460
Withdrew: Withdrawal by subject2438
Withdrew: Death21
Withdrew: Sponsor decision01
Withdrew: Lost to follow-up105
Withdrew: Other813
Withdrew: Reason missing02
All-IP Period (Years 2 to 5)
Participant flow — All-IP Period (Years 2 to 5)
MilestoneStandard of CareEvolocumab + SOC
Started398822
Received evolocumab374777
Completed328682
Not completed70140
Withdrew: Lost to follow-up2130
Withdrew: Withdrawal by subject3066
Withdrew: Death313
Withdrew: Sponsor decision10
Withdrew: Other1431
Withdrew: Reason missing10

Outcome measures

PrimaryNumber of Participants With Adverse Events

Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.03, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE.

Time frame:
52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; actual median duration of treatment in the All-IP period was 46.9 months.
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events
ParticipantsSOC-controlled Period: Standard of CareSOC-controlled Period: Evolocumab + SOCAll-IP Period: SOC / Evolocumab + SOCAll-IP Period: Evolocumab + SOC / Evolocumab + SOC
All adverse events327728342718
Adverse events ≥ grade 34699111229
Adverse events ≥ grade 4211828
Serious adverse events307276172
AEs leading to discontinuation of evolocumab0281627
Fatal adverse events0013
SecondaryLow-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52
Time frame:
Baseline of parent study and extension study weeks 24 and 52
Reported as:
Mean · mg/dL
Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52
mg/dLStandard of CareEvolocumab + SOCControl in Parent Study: SOCControl in Parent Study: Evolocumab + SOCEvolocumab in Parent Study: SOCEvolocumab in Parent Study: Evolocumab + SOC
Parent Study Baseline144.6 ± 37.4139.7 ± 36.7147.7 ± 34.3139.5 ± 33.6143.4 ± 38.5139.8 ± 37.8
Week 24136.9 ± 41.564.1 ± 33.3142.5 ± 44.763.9 ± 34.6134.8 ± 40.264.2 ± 32.9
Week 52140.5 ± 40.065.0 ± 34.4143.1 ± 39.864.1 ± 33.2139.4 ± 40.165.3 ± 34.9
SecondaryNon-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52
Time frame:
Baseline of parent study and extension study weeks 24 and 52
Reported as:
Mean · mg/dL
Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52
mg/dLStandard of CareEvolocumab + SOCControl in Parent Study: SOCControl in Parent Study: Evolocumab + SOCEvolocumab in Parent Study: SOCEvolocumab in Parent Study: Evolocumab + SOC
Parent Study Baseline170.7 ± 43.0165.1 ± 40.9173.8 ± 39.6165.5 ± 38.9169.6 ± 44.2165.0 ± 41.7
Week 24161.4 ± 45.584.3 ± 37.7166.9 ± 47.584.3 ± 39.0159.4 ± 44.684.3 ± 37.3
Week 52164.9 ± 44.585.3 ± 39.0168.8 ± 45.385.0 ± 38.4163.4 ± 44.185.4 ± 39.2
SecondaryApolipoprotein B Level at Week 24 and Week 52
Time frame:
Baseline of parent study and extension study weeks 24 and 52
Reported as:
Mean · mg/dL
Apolipoprotein B Level at Week 24 and Week 52
mg/dLStandard of CareEvolocumab + SOCControl in Parent Study: SOCControl in Parent Study: Evolocumab + SOCEvolocumab in Parent Study: SOCEvolocumab in Parent Study: Evolocumab + SOC
Parent Study Baseline113.2 ± 25.3110.4 ± 23.8115.4 ± 23.1110.3 ± 22.4112.4 ± 26.0110.4 ± 24.3
Week 24107.9 ± 26.360.8 ± 23.3110.5 ± 27.060.7 ± 23.9106.9 ± 26.060.9 ± 23.1
Week 52109.5 ± 26.861.6 ± 23.5110.7 ± 26.361.7 ± 23.0109.1 ± 27.061.6 ± 23.7
SecondaryTotal Cholesterol/HDL-C Ratio at Week 24 and Week 52
Time frame:
Baseline of parent study and extension study weeks 24 and 52
Reported as:
Mean · ratio
Total Cholesterol/HDL-C Ratio at Week 24 and Week 52
ratioStandard of CareEvolocumab + SOCControl in Parent Study: SOCControl in Parent Study: Evolocumab + SOCEvolocumab in Parent Study: SOCEvolocumab in Parent Study: Evolocumab + SOC
Parent Study Baseline4.516 ± 1.6174.386 ± 1.3934.458 ± 1.3454.388 ± 1.3404.538 ± 1.7084.386 ± 1.413
Week 244.198 ± 1.5362.603 ± 0.9784.192 ± 1.4082.594 ± 0.9704.201 ± 1.5842.607 ± 0.982
Week 524.277 ± 1.6522.626 ± 1.0254.252 ± 1.4342.622 ± 1.0334.286 ± 1.7332.628 ± 1.023
SecondaryApolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52
Time frame:
Baseline of parent study and extension study weeks 24 and 52
Reported as:
Mean · ratio
Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52
ratioStandard of CareEvolocumab + SOCControl in Parent Study: SOCControl in Parent Study: Evolocumab + SOCEvolocumab in Parent Study: SOCEvolocumab in Parent Study: Evolocumab + SOC
Parent Study Baseline0.759 ± 0.2370.739 ± 0.2170.764 ± 0.2010.735 ± 0.2120.757 ± 0.2490.741 ± 0.218
Week 240.717 ± 0.2420.386 ± 0.1780.715 ± 0.2220.385 ± 0.1830.718 ± 0.2500.387 ± 0.176
Week 520.726 ± 0.2560.394 ± 0.1850.719 ± 0.2160.393 ± 0.1860.729 ± 0.2710.394 ± 0.185

Adverse events

Collected over 52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; median duration of treatment in the All-IP period was 46.9 months.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SOC-controlled Period: SOC2/442 (0.5%)30/442 (6.8%)217/442 (49.1%)
SOC-controlled Period: Evolocumab + SOC1/882 (0.1%)72/882 (8.2%)513/882 (58.2%)
All-IP Period: SOC / Evolocumab3/398 (0.8%)78/398 (19.6%)311/398 (78.1%)
All-IP Period: Evolocumab + SOC / Evolocumab13/822 (1.6%)181/822 (22%)626/822 (76.2%)
All-IP Period: Total16/1,220 (1.3%)259/1,220 (21.2%)937/1,220 (76.8%)
Most frequent serious events
Showing 10 of 345
Most frequent serious events
EventSOC-controlled Period: SOCSOC-controlled Period: Evolocumab + SOCAll-IP Period: SOC / EvolocumabAll-IP Period: Evolocumab + SOC / EvolocumabAll-IP Period: Total
OsteoarthritisMusculoskeletal and connective tissue disorders1/4423/8825/3989/82214/1220
Angina pectorisCardiac disorders2/4424/8821/3989/82210/1220
Atrial fibrillationCardiac disorders1/4421/8822/3987/8229/1220
Non-cardiac chest painGeneral disorders1/4424/8820/3987/8227/1220
Chest painGeneral disorders1/4424/8821/3986/8227/1220
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/4420/8821/3985/8226/1220
AppendicitisInfections and infestations1/4425/8822/3983/8225/1220
Coronary artery diseaseCardiac disorders0/4421/8822/3984/8226/1220
CataractEye disorders0/4420/8822/3982/8224/1220
Inguinal herniaGastrointestinal disorders1/4420/8822/3980/8222/1220
Most frequent other events
Showing 10 of 23
Most frequent other events
EventSOC-controlled Period: SOCSOC-controlled Period: Evolocumab + SOCAll-IP Period: SOC / EvolocumabAll-IP Period: Evolocumab + SOC / EvolocumabAll-IP Period: Total
NasopharyngitisInfections and infestations64/442148/882122/398236/822358/1220
ArthralgiaMusculoskeletal and connective tissue disorders18/44259/88263/398109/822172/1220
Upper respiratory tract infectionInfections and infestations29/44272/88257/398118/822175/1220
Back painMusculoskeletal and connective tissue disorders22/44262/88251/398117/822168/1220
HypertensionVascular disorders20/44252/88240/39899/822139/1220
InfluenzaInfections and infestations24/44257/88247/39881/822128/1220
BronchitisInfections and infestations17/44248/88240/39894/822134/1220
CoughRespiratory, thoracic and mediastinal disorders19/44241/88240/39877/822117/1220
Pain in extremityMusculoskeletal and connective tissue disorders14/44244/88232/39870/822102/1220
DiarrhoeaGastrointestinal disorders11/44241/88233/39861/82294/1220

Baseline characteristics

The full analysis set included all randomized participants

Age, Continuous
Age, Continuous(years)Standard of CareEvolocumab + SOCTotal
Mean57.6 ± 11.556.9 ± 11.657.1 ± 11.6
Age, Customized
Age, Customized(Participants)Standard of CareEvolocumab + SOCTotal
< 65 years307632939
≥ 65 years135250385
Sex: Female, Male
Sex: Female, Male(Participants)Standard of CareEvolocumab + SOCTotal
Female241459700
Male201423624
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Standard of CareEvolocumab + SOCTotal
Hispanic or Latino133952
Not Hispanic or Latino4298431272
Unknown or Not Reported000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Standard of CareEvolocumab + SOCTotal
American Indian or Alaska Native314
Asian87168255
Black or African American245478
Native Hawaiian or Other Pacific Islander257
White325648973
Other145
Mixed Race022
Region
Region(Participants)Standard of CareEvolocumab + SOCTotal
North America214441655
Europe133261394
Asia Pacific95180275
Parent Study Baseline Low-density Lipoprotein Cholesterol (LDL-C) Concentration
Parent Study Baseline Low-density Lipoprotein Cholesterol (LDL-C) Concentration(mg/dL)Standard of CareEvolocumab + SOCTotal
Mean144.6 ± 37.4139.7 ± 36.7141.3 ± 37.0
Stratification Factor: Parent Study Treatment Assignment
Stratification Factor: Parent Study Treatment Assignment(Participants)Standard of CareEvolocumab + SOCTotal
Evolocumab once monthly (QM)193387580
Evolocumab every 2 weeks (Q2M)129256385
No evolocumab120239359
08

Study locations

187 sites
  • Research Site
    Birmingham, Alabama 35216, United States
  • Research Site
    Birmingham, Alabama 35294, United States
  • Research Site
    Tucson, Arizona 85710, United States
  • Research Site
    Little Rock, Arkansas 72205, United States
  • Research Site
    Malvern, Arkansas 72104, United States
  • Research Site
    Anaheim, California 92801, United States
  • Research Site
    Carmichael, California 95608, United States
  • Research Site
    Inglewood, California 90301, United States
  • Research Site
    Mission Viejo, California 92691, United States
  • Research Site
    Newport Beach, California 92663, United States
  • Research Site
    Thousand Oaks, California 91360, United States
  • Research Site
    Tustin, California 92780, United States
  • Research Site
    Colorado Springs, Colorado 80909, United States
  • Research Site
    Littleton, Colorado 80120, United States
  • Research Site
    Daytona Beach, Florida 32117, United States
  • Research Site
    DeLand, Florida 32720, United States
  • Research Site
    Green Cove Springs, Florida 32043, United States
  • Research Site
    Jacksonville, Florida 32216, United States
  • Research Site
    Jacksonville, Florida 32223, United States
  • Research Site
    Melbourne, Florida 32901, United States
  • Research Site
    Miami, Florida 33144, United States
  • Research Site
    Miami, Florida 33173, United States
  • Research Site
    Ponte Vedra, Florida 32081, United States
  • Research Site
    Port Charlotte, Florida 33952, United States
  • Research Site
    Sanford, Florida 32771, United States
  • Research Site
    Atlanta, Georgia 30338, United States
  • Research Site
    Savannah, Georgia 31406, United States
  • Research Site
    Chicago, Illinois 60654, United States
  • Research Site
    Indianapolis, Indiana 46260, United States
  • Research Site
    Munster, Indiana 46321, United States
  • Research Site
    Iowa City, Iowa 52242, United States
  • Research Site
    Louisville, Kentucky 40213, United States
  • Research Site
    Auburn, Maine 04210, United States
  • Research Site
    Portland, Maine 04101, United States
  • Research Site
    Bethesda, Maryland 20817, United States
  • Research Site
    Chevy Chase, Maryland 20815, United States
  • Research Site
    Brockton, Massachusetts 02301, United States
  • Research Site
    Marquette, Michigan 49855, United States
  • Research Site
    Brooklyn Center, Minnesota 55430, United States
  • Research Site
    Tupelo, Mississippi 38801, United States
  • Research Site
    Great Falls, Montana 59405, United States
  • Research Site
    Henderson, Nevada 89052, United States
  • Research Site
    Las Vegas, Nevada 89117, United States
  • Research Site
    Las Vegas, Nevada 89148, United States
  • Research Site
    Cortlandt Manor, New York 10567, United States
  • Research Site
    Endwell, New York 13760, United States
  • Research Site
    New York, New York 10029, United States
  • Research Site
    Williamsville, New York 14221, United States
  • Research Site
    Raleigh, North Carolina 27609, United States
  • Research Site
    Raleigh, North Carolina 27612, United States
  • Research Site
    Winston-Salem, North Carolina 27103, United States
  • Research Site
    Fargo, North Dakota 58103, United States
  • Research Site
    Akron, Ohio 44311, United States
  • Research Site
    Cadiz, Ohio 43907, United States
  • Research Site
    Cincinnati, Ohio 45219, United States
  • Research Site
    Cincinnati, Ohio 45227, United States
  • Research Site
    Cincinnati, Ohio 45246, United States
  • Research Site
    Cleveland, Ohio 44122, United States
  • Research Site
    Dayton, Ohio 45414, United States
  • Research Site
    Norman, Oklahoma 73069, United States
  • Research Site
    Oklahoma City, Oklahoma 73103, United States
  • Research Site
    Camp Hill, Pennsylvania 17011, United States
  • Research Site
    Duncansville, Pennsylvania 16635, United States
  • Research Site
    Pittsburgh, Pennsylvania 15216, United States
  • Research Site
    York, Pennsylvania 17405, United States
  • Research Site
    Mount Pleasant, South Carolina 29464, United States
  • Research Site
    Rapid City, South Dakota 57701, United States
  • Research Site
    Rapid City, South Dakota 57702, United States
  • Research Site
    Bristol, Tennessee 37620, United States
  • Research Site
    Arlington, Texas 76018, United States
  • Research Site
    Houston, Texas 77002, United States
  • Research Site
    Houston, Texas 77074, United States
  • Research Site
    San Antonio, Texas 78229, United States
  • Research Site
    Norfolk, Virginia 23502, United States
  • Research Site
    Richmond, Virginia 23294, United States
  • Research Site
    Renton, Washington 98057, United States
  • Research Site
    Seattle, Washington 98122, United States
  • Research Site
    Tacoma, Washington 98405, United States
  • Research Site
    Camperdown, New South Wales 2015, Australia
  • Research Site
    Maroubra, New South Wales 2035, Australia
  • Research Site
    Sydney, New South Wales 2022, Australia
  • Research Site
    Perth, Western Australia 6000, Australia
  • Research Site
    Anthée, 5520, Belgium
  • Research Site
    Bruxelles, 1200, Belgium
  • Research Site
    Gozee, 6534, Belgium
  • Research Site
    Gribomont, 6887, Belgium
  • Research Site
    Halen, 3545, Belgium
  • Research Site
    Ham, 3945, Belgium
  • Research Site
    Linkebeek, 1630, Belgium
  • Research Site
    Ukkel, 1180, Belgium
  • Research Site
    Kelowna, British Columbia V1Y 1V6, Canada
  • Research Site
    Bay Roberts, Newfoundland and Labrador A0A 1G0, Canada
  • Research Site
    Mount Pearl, Newfoundland and Labrador A1N 1W7, Canada
  • Research Site
    St. John's, Newfoundland and Labrador A1A 3R5, Canada
  • Research Site
    Cambridge, Ontario N1R 6V6, Canada
  • Research Site
    London, Ontario N5W 6A2, Canada
  • Research Site
    London, Ontario N6A 5B7, Canada
  • Research Site
    Newmarket, Ontario L3Y 5G8, Canada
  • Research Site
    Sarnia, Ontario N7T 4X3, Canada
  • Research Site
    Sudbury, Ontario P3C 5K7, Canada

Showing the first 100 of 187 sites across 18 countries.

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References and documents

Publications

  • Koren MJ, Sabatine MS, Giugliano RP, Langslet G, Wiviott SD, Kassahun H, Ruzza A, Ma Y, Somaratne R, Raal FJ. Long-term Low-Density Lipoprotein Cholesterol-Lowering Efficacy, Persistence, and Safety of Evolocumab in Treatment of Hypercholesterolemia: Results Up to 4 Years From the Open-Label OSLER-1 Extension Study. JAMA Cardiol. 2017 Jun 1;2(6):598-607. doi: 10.1001/jamacardio.2017.0747. PubMed 28291870 ↗
  • Koren MJ, Giugliano RP, Raal FJ, Sullivan D, Bolognese M, Langslet G, Civeira F, Somaratne R, Nelson P, Liu T, Scott R, Wasserman SM, Sabatine MS; OSLER Investigators. Efficacy and safety of longer-term administration of evolocumab (AMG 145) in patients with hypercholesterolemia: 52-week results from the Open-Label Study of Long-Term Evaluation Against LDL-C (OSLER) randomized trial. Circulation. 2014 Jan 14;129(2):234-43. doi: 10.1161/CIRCULATIONAHA.113.007012. Epub 2013 Nov 19. PubMed 24255061 ↗
  • Daviglus ML, Ferdinand KC, Lopez JAG, Wu Y, Monsalvo ML, Rodriguez CJ. Effects of Evolocumab on Low-Density Lipoprotein Cholesterol, Non-High Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a) by Race and Ethnicity: A Meta-Analysis of Individual Participant Data From Double-Blind and Open-Label Extension Studies. J Am Heart Assoc. 2021 Jan 5;10(1):e016839. doi: 10.1161/JAHA.120.016839. Epub 2020 Dec 16. PubMed 33325247 ↗
  • Hovingh GK, Raal FJ, Dent R, Stefanutti C, Descamps O, Masana L, Lira A, Bridges I, Coll B, Sullivan D. Long-term safety, tolerability, and efficacy of evolocumab in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2017 Nov-Dec;11(6):1448-1457. doi: 10.1016/j.jacl.2017.09.003. Epub 2017 Sep 22. PubMed 29066265 ↗
  • Koren MJ, Sabatine MS, Giugliano RP, Langslet G, Wiviott SD, Ruzza A, Ma Y, Hamer AW, Wasserman SM, Raal FJ. Long-Term Efficacy and Safety of Evolocumab in Patients With Hypercholesterolemia. J Am Coll Cardiol. 2019 Oct 29;74(17):2132-2146. doi: 10.1016/j.jacc.2019.08.1024. PubMed 31648705 ↗
  • Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7. PubMed 29353350 ↗
  • Sattar N, Toth PP, Blom DJ, Koren MJ, Soran H, Uhart M, Elliott M, Cyrille M, Somaratne R, Preiss D. Effect of the Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Evolocumab on Glycemia, Body Weight, and New-Onset Diabetes Mellitus. Am J Cardiol. 2017 Nov 1;120(9):1521-1527. doi: 10.1016/j.amjcard.2017.07.047. Epub 2017 Jul 31. PubMed 28844508 ↗
  • Toth PP, Jones SR, Monsalvo ML, Elliott-Davey M, Lopez JAG, Banach M. Effect of Evolocumab on Non-High-Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a): A Pooled Analysis of Phase 2 and Phase 3 Studies. J Am Heart Assoc. 2020 Mar 3;9(5):e014129. doi: 10.1161/JAHA.119.014129. Epub 2020 Mar 2. PubMed 32114889 ↗
  • Schludi B, Giugliano RP, Sabatine MS, Raal FJ, Teramoto T, Koren MJ, Stein EA, Wang H, Monsalvo ML. Time-averaged low-density lipoprotein cholesterol lowering with evolocumab: Pooled analysis of phase 2 trials. J Clin Lipidol. 2022 Jul-Aug;16(4):538-543. doi: 10.1016/j.jacl.2022.05.069. Epub 2022 Jun 6. PubMed 35760720 ↗
  • Hirayama A, Yamashita S, Ruzza A, Inomata H, Cyrille M, Lu C, Hamer AW, Yoshida M, Kiyosue A, Teramoto T. Long-Term Treatment With Evolocumab Among Japanese Patients - Final Report of the OSLER Open-Label Extension Studies. Circ J. 2019 Apr 25;83(5):971-977. doi: 10.1253/circj.CJ-19-0139. Epub 2019 Mar 29. PubMed 30930429 ↗
  • Sabatine MS, Giugliano RP, Wiviott SD, Raal FJ, Blom DJ, Robinson J, Ballantyne CM, Somaratne R, Legg J, Wasserman SM, Scott R, Koren MJ, Stein EA; Open-Label Study of Long-Term Evaluation against LDL Cholesterol (OSLER) Investigators. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1500-9. doi: 10.1056/NEJMoa1500858. Epub 2015 Mar 15. PubMed 25773607 ↗

Study documents

  • Study protocol · Nov 12, 2015
  • Statistical analysis plan · Feb 22, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01439880
Lead sponsor
Amgen
Responsible party
Sponsor
First posted
Sep 23, 2011
Start date
Oct 7, 2011
Primary completion
Jun 20, 2018
Completion
Jun 20, 2018
Results posted
Jul 10, 2019
Last update
Sep 21, 2022

Study contacts

MD
study director · Amgen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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