AzTrials
AzTrials

HypercholesterolemiaPhase 2NCT03175367

Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia

A Phase 2 study testing Evinacumab and Background Lipid Modifying Therapy (LMT) in people with Hypercholesterolemia, run by Regeneron Pharmaceuticals at 95 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective of the study is to evaluate the reduction of LDL-C by evinacumab in comparison to placebo after 16 weeks in patients with primary hypercholesterolemia (HeFH, or non-HeFH with a history of clinical ASCVD) with persistent hypercholesterolemia despite receiving maximally-tolerated LMT. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hypercholesterolemia
What is being tested?
Evinacumab and Background Lipid Modifying Therapy (LMT)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
272 participants
Where
95 sitesin 20 countries
Study dates
10 Nov 2017to 14 Dec 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women, ages 18 through 80 at the screening visit
  • Diagnosis of primary hypercholesterolemia, either HeFH or non-HeFH with clinical ASCVD
  • A history of clinical ASCVD, for those patients who are non-HeFH.
  • Receiving a stable maximally tolerated statin (± ezetimibe) for at least 4 weeks at screening
  • For those patients with HeFH who are not receiving a statin at screening, documentation of inability to tolerate at least 2 statins.
  • Receiving alirocumab 150 mg SC Q2W, OR evolocumab 140 mg SC Q2W or 420 mg SC Q4W for at least 8 weeks prior to the screening visit
Show all 9Show fewer
  • For those patients with a history of clinical ASCVD, serum LDL-C ≥ 70 mg/dL at screening (1 repeat lab is allowed)
  • For those patients without a history of clinical ASCVD, serum LDL-C ≥ 100 mg/dL at screening (1 repeat lab is allowed)
  • Provide signed informed consent

Who cannot join

  • Known history of homozygous FH (clinically, or by previous genotyping)
  • Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins
  • Newly diagnosed diabetes (within 3 months prior to screening)
  • Use of thyroid medications (except for replacement therapy which has been stable for at least 12 weeks before screening)
  • Laboratory findings during screening period (not including randomization labs):
  • Triglycerides > 400 mg/dL (> 4.52 mmol/L) for patients without a known history of diabetes mellitus; OR Triglycerides > 300 mg/dL (> 3.39 mmol/L) for patients with a known history of diabetes mellitus
Show all 19Show fewer
  • Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody (associated with a positive HCV ribonucleic acid [RNA] polymerase chain reaction)
  • Positive serum beta-human chorionic gonadotropin or urine pregnancy test in women of childbearing potential
  • Estimated glomerular filtration rate < 30 mL/min/1.73 m^2
  • TSH > 1.5 x ULN
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 x ULN
  • Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at screening visit or time of randomization
  • History of heart failure (New York Heart Association [NYHA] Class III-IV) within 12 months before screening
  • History of MI, unstable angina leading to hospitalization, CABG surgery, PCI, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, TIA, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease within 3 months prior screening
  • History of cancer within the past 5 years (except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer)
  • Having received LDL apheresis within 2 months before screening
  • Pregnant or breast-feeding women
  • Women of childbearing potential who are unwilling to practice a highly effective birth control method
  • Men who are sexually active with women of childbearing potential (WOCBP) and are unwilling to consistently use condoms during the study drug treatment period regardless of vasectomy status.

Trial locations and contacts

95 sites in 20 countries.

95 sites in 20 countries

United States23 sites

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • EMMC Northeast Cardiology Assocites

    Bangor, Maine, 04401

  • Preventive Cardiology Inc

    Boca Raton, Florida, 33434

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania, 17011

  • Care Research Center Inc

    Doral, Florida, 33166

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Heart Health Cardiology

    Grand Rapids, Michigan, 49546

  • The University Of Texas Health Science Center Houston

    Houston, Texas, 77030

  • St. Vincent Medical Group, Inc

    Indianapolis, Indiana, 46290

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Mt Sinai Ichan Medical Institute

    New York, New York, 10029

  • Office of Dr. John D Homan MD

    Newport Beach, California, 92663-3668

  • Rowan Diagnostic Clinic

    Salisbury, North Carolina, 28144

  • Wasatch Clinical Research

    Salt Lake City, Utah, 84107

  • San Antonio Premiere Internal Medicine

    San Antonio, Texas, 78220

  • Clear Clinical Research, LLC

    Schertz, Texas, 78154

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • PharmaTex Research

    Tyler, Texas, 75701

  • Florida Lipid Institute

    Winter Park, Florida, 32792

Other trials in United States

Russia11 sites

  • Federal State Budgetary Institution Research Institute for Complex Issues of Cardiovacsular Disease

    Kemerovo, 65000

  • National Research Center For Preventative Medicine of Federal Agency of High Technology Medical Aid

    Moscow, 119990

  • Federal State Budget Institution Out-patient Clinic 3

    Moscow, 129090

  • NII of Therapy and Preventive Medicine

    Novosibirsk, 630089

  • Municipal Medical and Prophylactic Institution - City Hospital for Emergency Care No.2

    Rostov-on-Don, 34406

  • Limmited Liability Company International Medical Centre SOGAZ

    Saint Petersburg, 191186

  • Federal State Institution of Healthcare Clinical Hospital #122 N.A.L.G Sokolov

    Saint Petersburg, 194291

  • LLC- Institute of Medical Research

    Saint Petersburg, 196084

  • Federal State Budgetary Institution Clinical-Diagnostic Center with Polyclinic

    Saint Petersburg, 197110

  • Samara Regional Clinical Cardiologic Dispensary

    Samara, 443070

  • Cardiology Research Institute

    Tomsk, 34012

Other trials in Russia

Spain6 sites

  • Hospital Universitario A Coruna

    A Coruña, A Coruna, 15001

  • Hospital Universitario de Bellvitge

    Barcelona, 08907

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Universitario Virgen de las Nieves (HUVN)

    Granada, 18014

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitario Miguel Servet

    Zaragoza, Aragon, 50009

Other trials in Spain

South Africa5 sites

  • Dr JM Engelbrecht Trial Site

    Cape Town, Western Cape, 713

  • University of Cape Town

    Cape Town, 7925

  • The Charlotte Maxeke Johannesburg Academic Hospital

    Johannesburg, Gauteng, 2000

  • TREAD Research CC

    Parow, 7500

  • Jongaie Research

    Pretoria, West Gauteng, 182

Other trials in South Africa

Canada4 sites

  • Centre Etudes Cliniques Econogene-21

    Chicoutimi, Quebec, G7H 7K9

  • Robarts Research Institute

    London, Ontario, N6A 5B7

  • SKDS Research Inc.

    Newmarket, Ontario, L3Y 5G8

  • Clinique des maladies lipidiques de Quebec

    Québec, Quebec, G1V 4W2

Other trials in Canada

Czechia4 sites

  • University Hospital, Charles University

    Hradec Králové, 50008

  • Univerzita Karlova v Praze 1 Lekarska Fakulta

    Karlov, Praha 2, 121 08

  • CCR Prague, S.R.O

    Prague, Prague 3, 13000

  • Ikem Institut Klinicke A Experimentalni Mediciny

    Prague, 14021

Other trials in Czechia

Israel4 sites

  • Edith Wolfson Medical Center

    Holon, 58100

  • Galilee Medical Center

    Nahariya

  • Sheba Mc

    Ramat Gan, 5265601

  • Sourasky Medical Center, Cardiovascular Research Center

    Tel Aviv, 64239

Other trials in Israel

Italy4 sites

  • Azienda Ospedaliero Universitaria Federico II di Napoli

    Naples, 80131

  • Fondazione Toscana Gabriele Monasterio Per La Ricerca Medica E Di Sanita Pubblica

    Pisa, 56126

  • Ausl Della Romagna-Ospedale Degli Infermi

    Rimini, 47923

  • Dipartimento di Medicina Traslazionale e di Precisione dell'Università degli Studi di

    Rome, 00185

Other trials in Italy

Japan4 sites

  • Tokyo-Eki Center-building Clinic

    Chūōku, 103-0027

  • Shonan Fujisawa Tokushukai Hospital

    Fujisawa-shi, 251-0041

  • Minamino Cardiovascular Hospital

    Hachiōji, 192-0918

  • Saitama Medical University Hospital

    Iruma-gun, 350-0495

Other trials in Japan

Jordan4 sites

  • Istishari Hospital

    Amman, 11184

  • King Abdullah University Hospital-1

    Irbid, 22110

  • King Abdullah University Hospital-2

    Irbid, 22110

  • King Abdullah University Hospital

    Irbid, 22110

Other trials in Jordan

Netherlands4 sites

  • Academic Medical Center

    Amsterdam, 1105 AZ

  • Admiraal de Ruyter Ziekenhuis

    Goes, Zeeland, 4462 RA

  • VOC Hoorn

    Hoorn, Hoorn Noord-Hollan, 1624 NP

  • Universitair Medisch Centrum Utrech - Locatie AZU

    Utrecht

Other trials in Netherlands

Poland4 sites

  • Wojewodzki Szpital Specjalistyczny

    Bytom

  • Nzoz Przychodnia Specjalistyczna

    Ruda Slaska, Podlaskie Voivodeship, 41709

  • Slaskie Centrum Chorob Serca, III Katedra i Oddzial Kliniczny Kardiologii SUM- Oddzial Chorob Serca i Naczyn

    Zabrze, 41-800

  • Halina Serafin NZOZ Centrum Medyczne SERAFIN-MED

    Żarów, Lower Silesian Voivodeship, 58-130

Other trials in Poland

Sweden4 sites

  • Karolinska University Hospital

    Malmö

  • Akardo MedSite

    Stockholm, 11446

  • Karolinska Institutet

    Stockholm, SE-182 88

  • Akademiska sjukhuset

    Uppsala, 75185

Other trials in Sweden

New Zealand3 sites

  • Lipid and Diabetes Research Group

    Christchurch, Canterbury, 8011

  • Papamoa Pines Medical Centre

    Papamoa, 3118

  • Clinical Horizons NZ Ltd

    Tauranga, 3112

Other trials in New Zealand

Australia2 sites

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Redcliffe Hospital

    Redcliffe, Queensland, 1020

Other trials in Australia

Austria2 sites

  • Medizinische Universitaetsklinik Graz

    Graz, A-8036

  • University Hospital Innsbruck - Tyrolean Hospital

    Innsbruck, Tyrol, 6020

Other trials in Austria

Denmark2 sites

  • Sydvestjysk Sygehus

    Esbjerg, 6700

  • Regionshospitalet Herning

    Herning, 7400

Other trials in Denmark

France2 sites

  • Houpital Du Bocage

    Dijon, 21079

  • Hopital G Et R Laennec

    Nantes, Cedex, 44000

Other trials in France

United Kingdom2 sites

  • Royal Free Hospital-Royal Free London NHS Foundation Trust

    London, NW3 2QG

  • Royal Victoria Infirmary - The Newcastle Upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, NE1 4LP

Other trials in United Kingdom

Norway1 site

  • M3 Helse AS

    Oslo, 0373

Other trials in Norway

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Varying Doses and Dose Regimens of Evinacumab in Patients With Persistent Hypercholesterolemia Despite Maximally Tolerated Lipid Modifying Therapy

The primary objective of the study is to evaluate the reduction of LDL-C by evinacumab in comparison to placebo after 16 weeks in patients with primary hypercholesterolemia (HeFH, or non-HeFH with a history of clinical ASCVD) with persistent hypercholesterolemia despite receiving maximally-tolerated LMT. Persistent hypercholesterolemia is defined as LDL-C ≥70 mg/dL (1.81 mmol/L) for those patients with clinical ASCVD and LDL-C ≥100 mg/dL (2.59 mmol/L) for those patients without clinical ASCVD.

Being tested
Evinacumab, Matching placebo, Background Lipid Modifying Therapy (LMT)
Medical subject headings
Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EvinacumabDrug

    Also called REGN1500

    SC or IV administration

  • Matching placeboDrug

    SC or IV administration

  • Background Lipid Modifying Therapy (LMT)Other

    All participants should be on a stable, maximally tolerated statin throughout the duration of the study. The dose of statin and of PCSK9 inhibitor, such as alirocumab or evolocumab, as well as other LMT (if applicable), should remain stable throughout the study duration, from screening through the end of study (EOS) visit.

Study groups in NCT03175367
Study groupRoleWhat they receive
Group A: dosing regimen 1ExperimentalSC Evinacumab QW for 16 weeks
Receives: Drug: Evinacumab; Other: Background Lipid Modifying Therapy (LMT)
Group A: dosing regimen 2ExperimentalSC Evinacumab Q2W for 16 weeks (alternating with matching placebo on opposite weeks)
Receives: Drug: Evinacumab; Other: Background Lipid Modifying Therapy (LMT)
Group A: dosing regimen 3ExperimentalSC Evinacumab QW for 16 weeks
Receives: Drug: Evinacumab; Other: Background Lipid Modifying Therapy (LMT)
Group A: matching placeboExperimentalPlacebo SC QW for 16 weeks
Receives: Drug: Matching placebo; Other: Background Lipid Modifying Therapy (LMT)
Group B: dosing regimen 1ExperimentalIntravenous (IV) Evinacumab Q4W for 24 weeks
Receives: Drug: Evinacumab; Other: Background Lipid Modifying Therapy (LMT)
Group B: dosing regimen 2ExperimentalIV Evinacumab Q4W for 24 weeks
Receives: Drug: Evinacumab; Other: Background Lipid Modifying Therapy (LMT)
Group B: matching placeboExperimentalPlacebo IV Q4W for 24 weeks
Receives: Drug: Matching placebo; Other: Background Lipid Modifying Therapy (LMT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 (Intent-to-Treat [ITT] Estimand)

    Measured: Baseline and Week 16

Secondary outcomes (14)

  1. Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 (ITT Estimand)

    Measured: Baseline and Week 16

  2. Percent Change From Baseline in Apo B at Week 24 (ITT Estimand)

    Measured: Baseline and Week 24

  3. Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16 (ITT Estimand)

    Measured: Baseline and Week 16

  4. Percent Change From Baseline in Non-HDL-C at Week 24 (ITT Estimand)

    Measured: Baseline and Week 24

  5. Percentage of Participants With >= 30% Reduction in Calculated LDL-C at Week 16 (ITT Estimand)

    Measured: Week 16

  6. Percentage of Participants With >= 50% Reduction in Calculated LDL-C at Week 16 (ITT Estimand)

    Measured: Week 16

  7. Percentage of Participants With Calculated LDL-C < 50 mg/dL (1.30 mmol/L) at Week 16 (ITT Estimand)

    Percentage of Participants with Calculated LDL-C < 50 milligrams/deciliter (mg/dL) [1.30 Millimoles per liter (mmol/L)] at Week 16 (ITT Estimand)

    Measured: Week 16

  8. Percent Change From Baseline in Calculated LDL-C at Week 24 (ITT Estimand)

    Measured: Baseline and Week 24

  9. Percent Change From Baseline in Total Cholesterol (TC) at Week 16 (ITT Estimand)

    Measured: Baseline and Week 16

  10. Percent Change From Baseline in Total Cholesterol at Week 24 (ITT Estimand)

    Measured: Baseline and Week 24

  11. Percent Change From Baseline in Fasting Triglycerides at Week 16 (ITT Estimand)

    Measured: Baseline and Week 16

  12. Percent Change From Baseline in Fasting Triglycerides at Week 24 (ITT Estimand)

    Measured: Baseline and Week 24

  13. Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 16 (ITT Estimand)

    Measured: Baseline and Week 16

  14. Percent Change From Baseline in Lipoprotein (a) [Lp(a)] at Week 24 (ITT Estimand)

    Measured: Baseline and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2017
  2. Study start10 Nov 2017
  3. Primary completion22 May 2020
  4. Study completion14 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
272 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03175367
Sponsor's protocol ID
R1500-CL-1643
Other IDs
2017-001508-31, 2017
Status last verified
Jan 2023
First submitted
1 Jun 2017
Last updated
10 Feb 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Rosenson RS, Burgess LJ, Ebenbichler CF, Baum SJ, Stroes ESG, Ali S, Khilla N, McGinniss J, Gaudet D, Pordy R. Longer-Term Efficacy and Safety of Evinacumab in Patients With Refractory Hypercholesterolemia. JAMA Cardiol. 2023 Nov 1;8(11):1070-1076. doi: 10.1001/jamacardio.2023.2921.

    PubMed 37703006

  • Rosenson RS, Burgess LJ, Ebenbichler CF, Baum SJ, Stroes ESG, Ali S, Khilla N, Hamlin R, Pordy R, Dong Y, Son V, Gaudet D. Evinacumab in Patients with Refractory Hypercholesterolemia. N Engl J Med. 2020 Dec 10;383(24):2307-2319. doi: 10.1056/NEJMoa2031049. Epub 2020 Nov 15.

    PubMed 33196153

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Evinacumab and Background Lipid Modifying Therapy (LMT) in people with Hypercholesterolemia, run by Regeneron Pharmaceuticals at 95 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, Russia, Spain, South Africa, Canada and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 (Intent-to-Treat [ITT] Estimand) (time frame: Baseline and Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03175367, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in