HypercholesterolemiaPhase 2ASCEND-QWNCT07477704
A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia
A Phase 2 study testing Alirocumab in people with Hypercholesterolemia, run by Regeneron Pharmaceuticals at 34 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Alirocumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 438 participants
- Where
- 34 sitesUnited States
- Study dates
- 17 Jun 2026to 23 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Participant has elevated LDL-C level, as defined in the protocol
Who cannot join
- Participant plans to initiate or change dose of lipid-lowering therapy
- Use of any PCSK9 inhibitors
- NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Anaheim Clinical Trials
Anaheim, California, 92801
Pinnacle Research Group
Anniston, Alabama, 36207
Mercury Street Medical Group, PLLC
Butte, Montana, 59701
Charlottesville Medical Research
Charlottesville, Virginia, 22911
Tampa Bay Medical Research
Clearwater, Florida, 33761
Ohio Clinical Trials
Columbus, Ohio, 43212
Cullman Clinical Trials
Cullman, Alabama, 35055
Velocity Clinical Research Dallas
Dallas, Texas, 75230
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Velocity Clinical Research - Durham
Durham, North Carolina, 27701
Southwest General Healthcare Center
Fort Myers, Florida, 33907
Valley Institute of Research, Rockwood Medical Clinic
Fort Worth, Texas, 76164
Center for Advanced Research and Education
Gainesville, Georgia, 30501
Tribe Clinical Research
Greenville, South Carolina, 29607
East-West Medical Research Institute
Honolulu, Hawaii, 96814
Palm Research Center, Mountainview Medical Center
Las Vegas, Nevada, 89128
Balanced Life Health Care Solutions
Lawrenceville, Georgia, 30046
Cenexel CNS
Los Alamitos, California, 90720
L-MARC Research Center
Louisville, Kentucky, 40213
Tandem Clinical Research
Marrero, Louisiana, 70072
Velocity Clinical Research, Medford
Medford, Oregon, 97504
AMR Norman
Norman, Oklahoma, 73069
Coastal Carolina Research Center_North Charleston
North Charleston, South Carolina, 29405
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Velocity Clinical Research - Omaha
Omaha, Nebraska, 68134
Rainier Clinical Research Center
Renton, Washington, 98057
Be Well Clinical Studies - Round Rock
Round Rock, Texas, 78681
Flourish Research, Legacy Oaks Tower
San Antonio, Texas, 78229
Endeavor Clinical Trials
San Antonio, Texas, 78240
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
Precision Clinical Research
Sunrise, Florida, 33351
K2 Medical Research The Villages
The Villages, Florida, 32159
Diablo Clinical Research - Flourish Research
Walnut Creek, California, 94598
Accellacare of Wilmington
Wilmington, North Carolina, 28401
About this study
Official title: 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
- Conditions
- Hypercholesterolemia
- Being tested
- Alirocumab
- Keywords
- Obesity, Elevated Low-Density Lipoprotein Cholesterol (LDL-C) Levels
- Medical subject headings
- Hypercholesterolemia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlirocumabDrug
Also called Praluent®, REGN727, SAR236553
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Low Dose | Experimental | Not described Receives: Drug: Alirocumab |
| Arm 2 - Medium Dose | Experimental | Not described Receives: Drug: Alirocumab |
| Arm 3 - High Dose | Experimental | Not described Receives: Drug: Alirocumab |
| Arm 4 - Control Dose | Experimental | Not described Receives: Drug: Alirocumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in LDL-C
Measured: From Baseline through Week 12
Secondary outcomes (10)
Concentrations of total alirocumab in serum
Measured: Through Week 20
Concentrations of free Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) in serum
Measured: Through Week 20
Percent change in LDL-C
Measured: From Baseline through Week 8
Percent change in total cholesterol
Measured: From Baseline through Week 12
Percent change in non-High-Density Lipoprotein-Cholesterol (HDL-C)
Measured: From Baseline through Week 12
Percent change in HDL-C
Measured: From Baseline through Week 12
Percent change in triglycerides
Measured: From Baseline through Week 12
Percent change in Apolipoprotein B (ApoB)
Measured: From Baseline through Week 12
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Measured: Through Week 20
Severity of TEAEs
Measured: Through Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start17 Jun 2026
- Primary completion29 Dec 2026 (estimated)
- Study completion23 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477704
- Sponsor's protocol ID
- R727-CL-2553
- Acronym
- ASCEND-QW
- Status last verified
- Oct 2026
- First submitted
- 12 Mar 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Weekly Alirocumab in Adults With Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT07477704
- Acronym / sponsor ID
- ASCEND-QW / R727-CL-2553
- Conditions
- Hypercholesterolemia
- Keywords
- Obesity, Elevated Low-Density Lipoprotein Cholesterol (LDL-C) Levels
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- 29 Dec 2026 (estimated)
- Study completion
- 23 Feb 2027 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Participant has elevated LDL-C level, as defined in the protocol
Key exclusion criteria (3 listed)
- Participant plans to initiate or change dose of lipid-lowering therapy
- Use of any PCSK9 inhibitors
- NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlirocumabAlso: Praluent®, REGN727, SAR236553Administered per the protocol | Drug | Arm 1 - Low Dose, Arm 2 - Medium Dose, Arm 3 - High Dose, Arm 4 - Control Dose |
Primary outcome
Percent change in LDL-C
Time frame: From Baseline through Week 12
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Related trials for Hypercholesterolemia
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
RecruitingPhase 3
Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
RecruitingPhase 1
Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia
Hypercholesterolemia, Hypertriglyceridemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alirocumab in people with Hypercholesterolemia, run by Regeneron Pharmaceuticals at 34 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in LDL-C (time frame: From Baseline through Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.