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

NCT07477704 | Recruiting Phase 2 FDA Drug

• 1 other identifier: R727-CL-2553
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 6

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percent change in LDL-C

  From Baseline through Week 12

Secondary Outcomes (10)

• Concentrations of total alirocumab in serum

  Through Week 20

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

  Through Week 20

• Percent change in LDL-C

  From Baseline through Week 8

• Percent change in total cholesterol

  From Baseline through Week 12

• Percent change in non-High-Density Lipoprotein-Cholesterol (HDL-C)

  From Baseline through Week 12

Study Arms (4)

Arm 1 - Low Dose

EXPERIMENTAL

Drug: Alirocumab

Arm 2 - Medium Dose

EXPERIMENTAL

Drug: Alirocumab

Arm 3 - High Dose

EXPERIMENTAL

Drug: Alirocumab

Arm 4 - Control Dose

EXPERIMENTAL

Drug: Alirocumab

Interventions

Alirocumab DRUG

Administered per the protocol

Also known as: Praluent®, REGN727, SAR236553

Arm 1 - Low Dose; Arm 2 - Medium Dose; Arm 3 - High Dose; Arm 4 - Control Dose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Participant has elevated LDL-C level, as defined in the protocol

You may not qualify if:

• Participant plans to initiate or change dose of lipid-lowering therapy
• Use of any PCSK9 inhibitors

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (6)

Precision Clinical Research

Sunrise, Florida, 33351, United States

RECRUITING

Balanced Life Health Care Solutions

Lawrenceville, Georgia, 30046, United States

RECRUITING

Mercury Street Medical Group, PLLC

Butte, Montana, 59701, United States

RECRUITING

Velocity Clinical Research - Durham

Durham, North Carolina, 27701, United States

RECRUITING

Velocity Clinical Research, Medford

Medford, Oregon, 97504, United States

RECRUITING

Velocity Clinical Research Dallas

Dallas, Texas, 75230, United States

RECRUITING

MeSH Terms

Conditions

Hypercholesterolemia; Obesity

Interventions

alirocumab

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start (Estimated): June 29, 2026
• Primary Completion (Estimated): December 29, 2026
• Study Completion (Estimated): February 23, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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
• 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

Locations

US (6)