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

Phase 2Not Yet RecruitingNCT07477704

Regeneron Pharmaceuticals420 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

420

Conditions

Hypercholesterolemia

Interventions

Alirocumab

Administered per the protocol

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: 1\. Participant has elevated LDL-C level, as defined in the protocol Key Exclusion Criteria: 1. Participant plans to initiate or change dose of lipid-lowering therapy 2. Use of any PCSK9 inhibitors 3. Participant has Type 1 diabetes NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply

Outcomes

Primary Outcomes

Percent change in LDL-C

Time frame: From Baseline through Week 12

Secondary Outcomes

Number of participants meeting up-titration of dose of alirocumab

Time frame: Week 12 through Week 24

Concentrations of total alirocumab in serum

Time frame: Through Week 32

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

Time frame: Through Week 32

Percent change in LDL-C