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Monoclonal Antibodies

Evinacumab for High Cholesterol

Phase 3
Waitlist Available
Research Sponsored by Daniel Gaudet
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HoFH patients having been previously or being currently treated with evinacumab or clinical diagnosis of HoFH requiring additional lipid lowering therapy.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 4 weeks up to 2 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial studies the long-term safety and effectiveness of a drug called evinacumab in treating adults with a cholesterol disorder called homozygous familial hypercholesterolemia.

Who is the study for?
Adults with homozygous familial hypercholesterolemia (HoFH) who are already on or need additional lipid-lowering therapy can join this trial. Pregnant or breastfeeding women, and women able to have children but not using effective birth control, cannot participate.
What is being tested?
The study is testing the long-term safety and effectiveness of Evinacumab, an antibody treatment for HoFH. It's added to existing treatments like statins in a real-life setting over up to 24 months, with follow-ups.
What are the potential side effects?
While specific side effects for Evinacumab aren't listed here, similar medications often cause injection site reactions, cold-like symptoms, nausea, muscle pain, and may affect liver enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have HoFH and need more treatment to lower my lipids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 4 weeks up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 4 weeks up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Body Weight Changes

Side effects data

From 2023 Phase 3 trial • 20 Patients • NCT04233918
33%
Rhinitis allergic
33%
Vitamin D deficiency
33%
Oropharyngeal pain
33%
Cough
17%
Vomiting
17%
Abdominal discomfort
17%
Iron deficiency
17%
Device malfunction
17%
Papilloedema
17%
Headache
17%
Rhinitis
17%
Infusion site extravasation
17%
Constipation
17%
Nasopharyngitis
17%
COVID-19
17%
Apheresis related complication
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A Evinacumab 15mg
Part B Evinacumab 15mg
Part A-C Evinacumab 15mg
Part B-C Evinacumab 15mg

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Evinacumab-treated patientsExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Evinacumab
2017
Completed Phase 3
~390

Find a Location

Who is running the clinical trial?

Daniel GaudetLead Sponsor
Ultragenyx Pharmaceutical IncIndustry Sponsor
93 Previous Clinical Trials
104,326 Total Patients Enrolled

Media Library

Evinacumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05611528 — Phase 3
Hypercholesterolemia Research Study Groups: Evinacumab-treated patients
Hypercholesterolemia Clinical Trial 2023: Evinacumab Highlights & Side Effects. Trial Name: NCT05611528 — Phase 3
Evinacumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05611528 — Phase 3
~0 spots leftby Dec 2024
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