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

Study acronym: ASCEND-QW
StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Enrollment closed, study ongoing Show 4 more changesShow less
    • Enrollment target: estimated 420 to confirmed 438
    • Secondary endpoints: details revised at 1 of 10 entries
    • Study sites revised (34)
    • Eligibility criteria expanded, about 2 words
  2. Trial sites expanded: 30 → 34 locationsv5
  3. Trial sites expanded: 6 → 30 locationsv4
  4. Start date changed from estimate of Jun 29, 2026 to Jun 17, 2026v3
  5. Recruitment openedv2 Show 6 more changesShow less
    • Start date: Apr 14, 2026 to Jun 29, 2026
    • Primary completion pushed from Oct 20, 2026 to Dec 29, 2026
    • Trial sites expanded: 0 → 6 locations
    • Study completion date: Mar 9, 2027 to Feb 23, 2027
    • Secondary endpoints: 11 to 10
    • Eligibility criteria shortened, about 5 words
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Regeneron
153 trials monitored
See 14 trials at risk
Obesity
3,888 trials monitored
See 157 trials at risk
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 Details
NCT Number NCT07477704
Lead Sponsor Regeneron Pharmaceuticals
Conditions
(from sponsor)		 Hypercholesterolemia
Related terms Hypercholesterolemia, Obesity
Enrollment 438 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov