420 Participants NeededMy employer runs this trial

Alirocumab for High Cholesterol

(ASCEND-QW Trial)

Recruiting at 33 trial locations
CT
Overseen ByClinical Trials Administrator
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Regeneron Pharmaceuticals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is researching an experimental drug called alirocumab, referred to as "study drug". In the United States, alirocumab is approved for the treatment of hypercholesterolemia (high blood cholesterol levels).

The aim of the study is to see how safe and effective alirocumab is when given weekly to adult participants who have hypercholesterolemia.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug once a week

* How much study drug is in the blood at different times

Who Is on the Research Team?

CT

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults with high cholesterol (specifically, elevated LDL-C levels). Participants should not have conditions or factors that would make it unsafe to join, as detailed in the study protocol.

Inclusion Criteria

Participant has elevated LDL-C level, as defined in the protocol

Exclusion Criteria

I plan to start or change my cholesterol-lowering medication.
I am currently using a PCSK9 inhibitor medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly doses of alirocumab to evaluate its safety and efficacy

12 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study is testing how safe and effective a drug called alirocumab is when given once a week to people with high cholesterol. Researchers will also measure drug levels in the blood and monitor for side effects.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Arm 4 - Control DoseExperimental Treatment1 Intervention
Group II: Arm 3 - High DoseExperimental Treatment1 Intervention
Group III: Arm 2 - Medium DoseExperimental Treatment1 Intervention
Group IV: Arm 1 - Low DoseExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials
690
Recruited
948,000+
Founded
1988
Headquarters
Tarrytown, USA
Known For
Precision medicine
Top Products
Dupixent, EYLEA, Libtayo, Praluent
Leonard Schleifer profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School