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

NCT07477704
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Recruiting
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Participants
420
clinicaltrials.gov
Lead sponsor
Regeneron Pharmaceuticals
clinicaltrials.gov
Start date
2026-06-17
clinicaltrials.gov
Number of sites
34
clinicaltrials.gov

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
clinicaltrials.gov
Acronym
ASCEND-QW
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Short title
A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia
clinicaltrials.gov
Official title
A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Weekly Alirocumab in Adults With Hypercholesterolemia
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2027-02-23
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First posted
2026-03-17
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Registry last updated
2026-07-22
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Primary completion date
2026-12-29
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Start date
2026-06-17
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Participants
420
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Participant count basis
Estimated
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Planned participants
420
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Protocol amendments
1
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Number of sites
34
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Regeneron Pharmaceuticals
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Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07477704
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07477704
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Percent change in LDL-C

    Timeframe: From Baseline through Week 12

  1. Concentrations of total alirocumab in serum

    Timeframe: Through Week 20

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

    Timeframe: Through Week 20

  3. Percent change in LDL-C

    Timeframe: From Baseline through Week 8

  4. Percent change in total cholesterol

    Timeframe: From Baseline through Week 12

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

    Timeframe: From Baseline through Week 12

  6. Percent change in HDL-C

    Timeframe: From Baseline through Week 12

  7. Percent change in triglycerides

    Timeframe: From Baseline through Week 12

  8. Percent change in Apolipoprotein B (ApoB)

    Timeframe: From Baseline through Week 12

  9. Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Timeframe: Through Week 20

  10. Severity of TEAEs

    Timeframe: Through Week 20

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No

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

Sources for eligibility
clinicaltrials.gov

  • Pinnacle Research GroupAnniston, United StatesRecruiting
  • Cullman Clinical TrialsCullman, United StatesRecruiting
  • Anaheim Clinical TrialsAnaheim, United StatesRecruiting
  • Cenexel CNSLos Alamitos, United StatesRecruiting
  • Diablo Clinical Research - Flourish ResearchWalnut Creek, United StatesRecruiting
  • Tampa Bay Medical ResearchClearwater, United StatesRecruiting
  • Southwest General Healthcare CenterFort Myers, United StatesRecruiting
  • Precision Clinical ResearchSunrise, United StatesRecruiting
  • K2 Medical Research The VillagesThe Villages, United StatesRecruiting
  • Center for Advanced Research and EducationGainesville, United StatesRecruiting
  • Balanced Life Health Care SolutionsLawrenceville, United StatesRecruiting
  • East-West Medical Research InstituteHonolulu, United StatesRecruiting
  • L-MARC Research CenterLouisville, United StatesRecruiting
  • Tandem Clinical ResearchMarrero, United StatesRecruiting
  • Mercury Street Medical Group, PLLCButte, United StatesRecruiting
  • Velocity Clinical Research - OmahaOmaha, United StatesRecruiting
  • Palm Research Center, Mountainview Medical CenterLas Vegas, United StatesRecruiting
  • Velocity Clinical Research - DurhamDurham, United StatesRecruiting
  • Accellacare of WilmingtonWilmington, United StatesRecruiting
  • Ohio Clinical TrialsColumbus, United StatesRecruiting
  • AMR NormanNorman, United StatesRecruiting
  • Lynn Health Science InstituteOklahoma City, United StatesRecruiting
  • Velocity Clinical Research, MedfordMedford, United StatesRecruiting
  • Altoona Center for Clinical ResearchDuncansville, United StatesRecruiting
  • Tribe Clinical ResearchGreenville, United StatesRecruiting

And 9 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)

Targets (1)