> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-see-how-safe-and-effective-alirocumab-is-when-cb1b958f-1198-45d0-a2e4-eeadfc2d0af2 > Record changed: 2026-10-13 # A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia NCT07477704 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) Participants 420 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) Lead sponsor Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) Start date 2026-06-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) Number of sites 34 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) **Acronym** ASCEND-QW Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) **Short title** A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) **Official title** A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Weekly Alirocumab in Adults With Hypercholesterolemia Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) ## Dates **Completion date** 2027-02-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) **First posted** 2026-03-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) **Registry last updated** 2026-07-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) **Primary completion date** 2026-12-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) **Start date** 2026-06-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) ## Size and sites **Participants** 420 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) **Planned participants** 420 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) **Number of sites** 34 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) **Lead sponsor** Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) ## Identifiers **Registry ID** NCT07477704 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) **ClinicalTrials.gov ID** NCT07477704 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) ## Outcomes ### Primary outcomes 1. Percent change in LDL-C Timeframe: From Baseline through Week 12 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) ## Eligibility **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07477704) ## Related records ### Drugs (1) - [Alirocumab](https://trialight.com/data/asset/alirocumab-94bb5dc8-32f2-4ed6-a82e-b554472e2cd5.md) ### Lead sponsors (1) - [Regeneron Pharmaceuticals](https://trialight.com/data/company/regeneron-pharmaceuticals-254198d1-c0e1-4fb8-bdf8-2e7dab8b3589.md) ### Conditions (2) - [Hypertriglyceridemia](https://trialight.com/data/condition/hypertriglyceridemia-538285c3-ad71-513e-bd58-6cc97634acb2.md) Primary condition - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) ### Targets (1) - [PCSK9](https://trialight.com/data/target/pcsk9-8d1e28c2-2f47-5dc5-b51e-ccfdc60cfc75.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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