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Healthy VolunteersPhase 1NCT03146416

Study of Evinacumab (REGN1500) in Caucasian and in Japanese Healthy Volunteers

A Phase 1 study testing Evinacumab in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 1 site in United States.

Completed

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

Official record
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Trial summary

The primary objective of the study is to compare the safety and tolerability of subcutaneous (SC) and intravenous (IV) doses of evinacumab in healthy Japanese and Caucasian subjects. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Evinacumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
1 siteUnited States
Study dates
16 May 2017to 14 Jun 2018
Phase
Phase 1
Are there results?
None posted in the registry

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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male or female Japanese and Caucasian volunteers ≥18 and ≤55 years of age at the screening visit.
  • Japanese subjects must:
  • Be first generation Japanese, defined as born in Japan and both biologic parents are ethnic Japanese
  • Have maintained a Japanese lifestyle that has not significantly changed since leaving Japan, including having access to Japanese food and adhering to a Japanese diet.
  • Caucasian subjects must be Caucasian of European or Latin American descent
  • Modest elevations in LDL-C (≥100 mg/dL, but <160 mg/dL)

Who cannot join

  • Significant concomitant illness
  • Known allergy or sensitivity to monoclonal antibodies (mAbs)
  • Previous exposure to anti-ANGPTL3 antibody
  • Body mass index (BMI) >35 kg/m2 at the screening visit
  • Note: Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

1 site in 1 country.

United States1 site

  • WCCT Global, Inc.

    Cypress, California, 90630

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Evinacumab in Healthy Japanese and Caucasian Subjects

The primary objective of the study is to compare the safety and tolerability of subcutaneous (SC) and intravenous (IV) doses of evinacumab in healthy Japanese and Caucasian subjects.

Being tested
Evinacumab, Placebo

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 of Evinacumab

  • PlaceboDrug

    Matching placebo

Study groups in NCT03146416
Study groupRoleWhat they receive
Cohort 1ExperimentalEvinacumab SC or placebo SC
Receives: Drug: Evinacumab; Drug: Placebo
Cohort 2ExperimentalLow dose regimen: evinacumab IV or placebo IV
Receives: Drug: Evinacumab; Drug: Placebo
Cohort 3ExperimentalHigh dose regimen: evinacumab IV or placebo IV
Receives: Drug: Evinacumab; Drug: Placebo
Cohort 4ExperimentalEvinacumab or placebo SC every week (QW) x 8 doses
Receives: Drug: Evinacumab; Drug: Placebo
Cohort 5ExperimentalEvinacumab or placebo SC x 1 dose
Receives: Drug: Evinacumab; Drug: Placebo

What is being measured

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

  1. Incidence of Treatment Emergent Adverse Events (TEAEs)

    Measured: Baseline up to week 31

  2. Severity of TEAEs

    Measured: Baseline up to week 31

Secondary outcomes (29)

  1. Pharmacokinetic (PK) parameters of evinacumab for geometric means of maximum (or peak) serum concentration (Cmax)

    Measured: Up to Week 31

  2. PK parameters of evinacumab for geometric means of Area under the curve (AUC) computed from time zero to the last measurable concentration (AUClast)

    single dose cohort

    Measured: Up to Week 31

  3. PK parameters of evinacumab for geometric means of AUC computed from time zero to the end of a dosing interval (AUCtau)

    following the first dose for the multiple dose cohorts

    Measured: Up to Week 31

  4. Ratio of Japanese versus Caucasian populations for geometric means of Cmax

    Measured: Up to Week 31

  5. Ratio of Japanese versus Caucasian populations for geometric means of AUClast

    single dose cohort

    Measured: Up to Week 31

  6. Ratio of Japanese versus Caucasian populations for geometric means of AUCtau

    following the first dose for the multiple dose cohorts

    Measured: Up to Week 31

  7. Absolute change from baseline over time in the Pharmacodynamic (PD) variable: Low-density lipoprotein cholesterol (LDL-C)

    Measured: Up to Week 31

  8. Absolute change from baseline over time in the PD variable: Total cholesterol

    Measured: Up to Week 31

  9. Absolute change from baseline over time in the PD variable: High-density lipoprotein cholesterol (HDL-C)

    Measured: Up to Week 31

  10. Absolute change from baseline over time in the PD variable: Triglycerides

    Measured: Up to Week 31

  11. Absolute change from baseline over time in the PD variable: non-HDL-C

    Measured: Up to Week 31

  12. Absolute change from baseline over time in the PD variable: lipoprotein a [Lp(a)]

    Measured: Up to Week 31

  13. Absolute change from baseline over time in the PD variable: apolipoprotein B [ApoB]

    Measured: Up to Week 31

  14. Absolute change from baseline over time in the PD variable: apolipoprotein A1 [ApoA1]

    Measured: Up to Week 31

  15. Absolute change from baseline over time in the PD variable: apolipoprotein C3 [ApoC3]

    Measured: Up to Week 31

  16. Absolute change from baseline over time in the PD variable: high-sensitivity C-reactive protein [hs-CRP]

    Measured: Up to Week 31

  17. Absolute change from baseline over time in the PD variable: Total Angiopoietin-like 3 (ANGPTL3)

    Measured: Up to Week 31

  18. Percent change from baseline over time in the PD variable: LDL-C

    Measured: Up to Week 31

  19. Percent change from baseline over time in the PD variable: Total cholesterol

    Measured: Up to Week 31

  20. Percent change from baseline over time in the PD variable: HDL-C

    Measured: Up to Week 31

  21. Percent change from baseline over time in the PD variable: Triglycerides

    Measured: Up to Week 31

  22. Percent change from baseline over time in the PD variable: non-HDL-C

    Measured: Up to Week 31

  23. Percent change from baseline over time in the PD variable: lipoprotein a [Lp(a)]

    Measured: Up to Week 31

  24. Percent change from baseline over time in the PD variable: apolipoprotein B [ApoB]

    Measured: Up to Week 31

  25. Percent change from baseline over time in the PD variable: apolipoprotein A1 [ApoA1]

    Measured: Up to Week 31

  26. Percent change from baseline over time in the PD variable: apolipoprotein C3 [ApoC3]

    Measured: Up to Week 31

  27. Percent change from baseline over time in the PD variable: high-sensitivity C-reactive protein [hs-CRP]

    Measured: Up to Week 31

  28. Percent change from baseline over time in the PD variable: Total (ANGPTL3)

    Measured: Up to Week 31

  29. Presence and titer of anti-evinacumab antibodies

    Measured: Up to Week 31

Timeline

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

  1. First posted10 May 2017
  2. Study start16 May 2017
  3. Primary completion14 Jun 2018
  4. Study completion14 Jun 2018

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 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03146416
Sponsor's protocol ID
R1500-CL-1642
Status last verified
Jun 2018
First submitted
7 May 2017
Last updated
25 Jun 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Harada-Shiba M, Ali S, Gipe DA, Gasparino E, Son V, Zhang Y, Pordy R, Catapano AL. A randomized study investigating the safety, tolerability, and pharmacokinetics of evinacumab, an ANGPTL3 inhibitor, in healthy Japanese and Caucasian subjects. Atherosclerosis. 2020 Dec;314:33-40. doi: 10.1016/j.atherosclerosis.2020.10.013. Epub 2020 Oct 10.

    PubMed 33130482

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Evinacumab in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 1 site in United States.

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 6 inclusion and 5 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 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of Treatment Emergent Adverse Events (TEAEs) (time frame: Baseline up to week 31). The study lists 2 primary outcomes in all. 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 NCT03146416, which also lists 1 linked publication.

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 25 Jun 2018.

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