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

March 12, 2026 updated by: Regeneron Pharmaceuticals

A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Weekly Alirocumab in Adults With Hypercholesterolemia

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

420

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 - Low Dose
Drug: Alirocumab
Administered per the protocol
Other Names:
  • SAR236553
  • REGN727
  • Praluent®
Experimental: Arm 2 - Medium Dose
Drug: Alirocumab
Administered per the protocol
Other Names:
  • SAR236553
  • REGN727
  • Praluent®
Experimental: Arm 3 - High Dose
Drug: Alirocumab
Administered per the protocol
Other Names:
  • SAR236553
  • REGN727
  • Praluent®
Experimental: Arm 4 - Higher Dose
Drug: Alirocumab
Administered per the protocol
Other Names:
  • SAR236553
  • REGN727
  • Praluent®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change in LDL-C
Time Frame: From Baseline through Week 12
From Baseline through Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Severity of TEAEs
Time Frame: Through Week 32
Through Week 32
Number of participants meeting up-titration of dose of alirocumab
Time Frame: Week 12 through Week 24
Week 12 through Week 24
Concentrations of total alirocumab in serum
Time Frame: Through Week 32
Through Week 32
Concentrations of free Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) in serum
Time Frame: Through Week 32
Through Week 32
Percent change in LDL-C
Time Frame: From Baseline through Week 24
From Baseline through Week 24
Percent change in total cholesterol
Time Frame: From Baseline through Week 24
From Baseline through Week 24
Percent change in non-High-Density Lipoprotein-Cholesterol (HDL-C)
Time Frame: From Baseline through Week 24
From Baseline through Week 24
Percent change in HDL-C
Time Frame: From Baseline through Week 24
From Baseline through Week 24
Percent change in triglycerides
Time Frame: From Baseline through Week 24
From Baseline through Week 24
Percent change in Apolipoprotein B (ApoB)
Time Frame: From Baseline through Week 24
From Baseline through Week 24
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Through Week 32
Through Week 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 14, 2026

Primary Completion (Estimated)

October 20, 2026

Study Completion (Estimated)

March 9, 2027

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R727-CL-2553

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD Sharing Time Frame

When Regeneron has:

  • received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy

IPD Sharing Access Criteria

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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