A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia
ASCEND-QW
A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Weekly Alirocumab in Adults With Hypercholesterolemia
1 other identifier
interventional
420
1 country
34
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2026
Shorter than P25 for phase_2
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2026
CompletedFirst Posted
Study publicly available on registry
March 17, 2026
CompletedStudy Start
First participant enrolled
June 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 23, 2027
July 22, 2026
July 1, 2026
7 months
March 12, 2026
July 20, 2026
Conditions
Keywords
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
- +5 more secondary outcomes
Study Arms (4)
Arm 1 - Low Dose
EXPERIMENTALArm 2 - Medium Dose
EXPERIMENTALArm 3 - High Dose
EXPERIMENTALArm 4 - Control Dose
EXPERIMENTALInterventions
Administered per the protocol
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Pinnacle Research Group
Anniston, Alabama, 36207, United States
Cullman Clinical Trials
Cullman, Alabama, 35055, United States
Anaheim Clinical Trials
Anaheim, California, 92801, United States
Cenexel CNS
Los Alamitos, California, 90720, United States
Diablo Clinical Research - Flourish Research
Walnut Creek, California, 94598, United States
Tampa Bay Medical Research
Clearwater, Florida, 33761, United States
Southwest General Healthcare Center
Fort Myers, Florida, 33907, United States
Precision Clinical Research
Sunrise, Florida, 33351, United States
K2 Medical Research The Villages
The Villages, Florida, 32159, United States
Center for Advanced Research and Education
Gainesville, Georgia, 30501, United States
Balanced Life Health Care Solutions
Lawrenceville, Georgia, 30046, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
Tandem Clinical Research
Marrero, Louisiana, 70072, United States
Mercury Street Medical Group, PLLC
Butte, Montana, 59701, United States
Velocity Clinical Research - Omaha
Omaha, Nebraska, 68134, United States
Palm Research Center, Mountainview Medical Center
Las Vegas, Nevada, 89128, United States
Velocity Clinical Research - Durham
Durham, North Carolina, 27701, United States
Accellacare of Wilmington
Wilmington, North Carolina, 28401, United States
Ohio Clinical Trials
Columbus, Ohio, 43212, United States
AMR Norman
Norman, Oklahoma, 73069, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Velocity Clinical Research, Medford
Medford, Oregon, 97504, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Tribe Clinical Research
Greenville, South Carolina, 29607, United States
Coastal Carolina Research Center_North Charleston
North Charleston, South Carolina, 29405, United States
Velocity Clinical Research Dallas
Dallas, Texas, 75230, United States
Valley Institute of Research, Rockwood Medical Clinic
Fort Worth, Texas, 76164, United States
Be Well Clinical Studies - Round Rock
Round Rock, Texas, 78681, United States
Flourish Research - San Antonio Medical Trials
San Antonio, Texas, 78229, United States
Endeavor Clinical Trials
San Antonio, Texas, 78240, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Central Study Contacts
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
June 17, 2026
Primary Completion (Estimated)
December 29, 2026
Study Completion (Estimated)
February 23, 2027
Last Updated
July 22, 2026
Record last verified: 2026-07
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
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.