A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Alirocumab.
- Who it may be relevant to
- Registry conditions: Hypercholesterolemia. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Weekly Alirocumab in Adults With Hypercholesterolemia
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
Interventions
- Drug Alirocumab
Administered per the protocol
Primary outcome measures
- Percent change in LDL-C [Time frame: From Baseline through Week 12]
Secondary outcome measures (10)
- Concentrations of total alirocumab in serum [Time frame: Through Week 20]
- Concentrations of free Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) in serum [Time frame: Through Week 20]
- Percent change in LDL-C [Time frame: From Baseline through Week 8]
- Percent change in total cholesterol [Time frame: From Baseline through Week 12]
- Percent change in non-High-Density Lipoprotein-Cholesterol (HDL-C) [Time frame: From Baseline through Week 12]
- Percent change in HDL-C [Time frame: From Baseline through Week 12]
- Percent change in triglycerides [Time frame: From Baseline through Week 12]
- Percent change in Apolipoprotein B (ApoB) [Time frame: From Baseline through Week 12]
- Occurrence of Treatment-Emergent Adverse Events (TEAEs) [Time frame: Through Week 20]
- Severity of TEAEs [Time frame: Through Week 20]
Eligibility criteria
Inclusion criteria
1\. Participant has elevated LDL-C level, as defined in the protocol
Exclusion criteria
- Participant plans to initiate or change dose of lipid-lowering therapy
- Use of any PCSK9 inhibitors
NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 34 centers
- Pinnacle Research Group — Anniston
- Cullman Clinical Trials — Cullman
- Anaheim Clinical Trials — Anaheim
- Cenexel CNS — Los Alamitos
- Diablo Clinical Research - Flourish Research — Walnut Creek
- Tampa Bay Medical Research — Clearwater
- Southwest General Healthcare Center — Fort Myers
- Precision Clinical Research — Sunrise
- … and 26 more centers
Identifiers
NCT: NCT07477704 · R727-CL-2553