Health TrialsbyHealthPanel

A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia

ConditionHypercholesterolemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRegeneron Pharmaceuticals

About 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Participant plans to initiate or change dose of lipid-lowering therapy

Use of any PCSK9 inhibitors

Trial design

Design model

Parallel

Treatments tested in this trial

  • Alirocumab

    Drug

    Administered per the protocol

Treatment groups

420 Participants
are divided into 4 treatment groups
Group A: Arm 1 - Low DoseExperimental treatment 1 intervention
Group B: Arm 2 - Medium DoseExperimental treatment 1 intervention
Group C: Arm 3 - High DoseExperimental treatment 1 intervention
Group D: Arm 4 - Control DoseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percent change in LDL-C

Time frame
From Baseline through Week 12

Secondary outcomes

1

Concentrations of total alirocumab in serum

Time frame
Through Week 20
2

Concentrations of free Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) in serum

Time frame
Through Week 20
3

Percent change in LDL-C

Time frame
From Baseline through Week 8
4

Percent change in total cholesterol

Time frame
From Baseline through Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Regeneron Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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