Recruiting
Phase 2

Alirocumab

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT07477704

Conditions

Hypercholesterolemia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Alirocumab

Study Details

Brief summary:

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

Conditions

Hypercholesterolemia

Study ID

NCT07477704

Start date

Jun 17, 2026

Status verified date

Jul, 2026

Completion date

Feb 23, 2027

Anticipated

Primary completion date

Dec 29, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply

Study Design

Enrollment

420 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1 - Low Dose

experimental: Arm 2 - Medium Dose

experimental: Arm 3 - High Dose

experimental: Arm 4 - Control Dose

Interventions

Alirocumab

Administered per the protocol

Primary outcome measure

  • Percent change in LDL-C [ Time Frame: From Baseline through Week 12 ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Pinnacle Research Group

Recruiting

Anniston, Alabama, United States, 36207

Cullman Clinical Trials

Recruiting

Cullman, Alabama, United States, 35055

Anaheim Clinical Trials

Recruiting

Anaheim, California, United States, 92801

Cenexel CNS

Recruiting

Los Alamitos, California, United States, 90720

Diablo Clinical Research - Flourish Research

Recruiting

Walnut Creek, California, United States, 94598

Tampa Bay Medical Research

Recruiting

Clearwater, Florida, United States, 33761

Southwest General Healthcare Center

Recruiting

Fort Myers, Florida, United States, 33907

Precision Clinical Research

Recruiting

Sunrise, Florida, United States, 33351

K2 Medical Research The Villages

Recruiting

The Villages, Florida, United States, 32159

Center for Advanced Research and Education

Recruiting

Gainesville, Georgia, United States, 30501

Balanced Life Health Care Solutions

Recruiting

Lawrenceville, Georgia, United States, 30046

East-West Medical Research Institute

Recruiting

Honolulu, Hawaii, United States, 96814

L-MARC Research Center

Recruiting

Louisville, Kentucky, United States, 40213

Tandem Clinical Research

Recruiting

Marrero, Louisiana, United States, 70072

Mercury Street Medical Group, PLLC

Recruiting

Butte, Montana, United States, 59701

Velocity Clinical Research - Omaha

Recruiting

Omaha, Nebraska, United States, 68134

Palm Research Center, Mountainview Medical Center

Recruiting

Las Vegas, Nevada, United States, 89128

Velocity Clinical Research - Durham

Recruiting

Durham, North Carolina, United States, 27701

Accellacare of Wilmington

Recruiting

Wilmington, North Carolina, United States, 28401

Ohio Clinical Trials

Recruiting

Columbus, Ohio, United States, 43212

AMR Norman

Recruiting

Norman, Oklahoma, United States, 73069

Lynn Health Science Institute

Recruiting

Oklahoma City, Oklahoma, United States, 73112

Velocity Clinical Research, Medford

Recruiting

Medford, Oregon, United States, 97504

Altoona Center for Clinical Research

Recruiting

Duncansville, Pennsylvania, United States, 16635

Tribe Clinical Research

Recruiting

Greenville, South Carolina, United States, 29607

Coastal Carolina Research Center_North Charleston

Recruiting

North Charleston, South Carolina, United States, 29405

Velocity Clinical Research Dallas

Recruiting

Dallas, Texas, United States, 75230

Valley Institute of Research, Rockwood Medical Clinic

Recruiting

Fort Worth, Texas, United States, 76164

Be Well Clinical Studies - Round Rock

Recruiting

Round Rock, Texas, United States, 78681

Flourish Research - San Antonio Medical Trials

Recruiting

San Antonio, Texas, United States, 78229

Endeavor Clinical Trials

Recruiting

San Antonio, Texas, United States, 78240

Consano Clinical Research, LLC

Recruiting

Shavano Park, Texas, United States, 78231

Charlottesville Medical Research

Recruiting

Charlottesville, Virginia, United States, 22911

Rainier Clinical Research Center

Recruiting

Renton, Washington, United States, 98057

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Obesity
  • Elevated Low-Density Lipoprotein Cholesterol (LDL-C) Levels

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-07-22.