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NCT03399786 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia
A Phase 3 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 65
- Enrollment target
NCT03399786: Completed Phase 3 study, sponsored by Regeneron Pharmaceuticals.
NCT03399786 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 65 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03399786, a Phase 3 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 65 participants
- Enrollment target
Study Summary
The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by evinacumab intravenously (IV) in comparison to placebo after 24 weeks in patients with homozygous familial hypercholesterolemia (HoFH). The secondary objectives of the study are to evaluate the effect of evinacumab IV on other lipid parameters, evaluate the effect of evinacumab on LDL-C goal attainment, assess the effect of evinacumab on eligibility for apheresis (using German and US apheresis criteria), evaluate the safety and tolerability of evinacumab in patients with HoFH, assess the pharmacokinetics (PK) of evinacumab in patients with HoFH and evaluate the potential development of anti-evinacumab antibodies.
Primary Outcome
Percent change was calculated as 100x(calculated LDL-C value at Week 24 - calculated LDL-C value at baseline)/calculated LDL-C value at baseline. The baseline LDL-C value was the last calculated LDL-C value obtained before the first dose of double-blind-study drug. The calculated LDL-C at week 24 was the LDL-C value obtained within the week 24 efficacy analysis window, regardless of adherence to treatment and subsequent therapies (intent-to-treat \[ITT\] estimand). The ITT population included al
Interventions
- DRUG Placebo
- DRUG evinacumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2018-01-18 |
| Est. Completion | 2020-03-17 |
| Phase | Phase 3 |
What the finished NCT03399786 record still lists
NCT03399786 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03399786 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03399786 about?
NCT03399786 is a clinical study titled "Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia". The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by evinacumab intravenously (IV) in comparison to placebo after 24 weeks in patients with homozygous familial hypercholesterolemia (HoFH). The secondary objectives of the study are to ev...
What is the current status of trial NCT03399786?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 65 participants. The study started on 2018-01-18. Estimated completion is 2020-03-17.
What interventions are being tested in trial NCT03399786?
The interventions under investigation include: Placebo (DRUG), evinacumab (DRUG).
Who is sponsoring clinical trial NCT03399786?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03399786's enrollment target sits among peer trials
65 1797th of 2000 higher than 202 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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