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NCT Number: NCT07477704

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

Recruiting

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Key information

Conditions

Hypercholesterolemia Body Weight Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pinnacle Research Group, Anniston, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Participant has elevated LDL-C level, as defined in the protocol

Key Exclusion Criteria:

  • Participant plans to initiate or change dose of lipid-lowering therapy
  • Use of any PCSK9 inhibitors

NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply

Treatment and study plan

Alirocumab

Drug

Administered per the protocol

Other names: Praluent®, REGN727, SAR236553

Primary outcomes

  1. Percent change in LDL-C

    Time frame: From Baseline through Week 12

Secondary outcomes

  1. Concentrations of total alirocumab in serum

    Time frame: Through Week 20

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

    Time frame: Through Week 20

  3. Percent change in LDL-C

    Time frame: From Baseline through Week 8

  4. Percent change in total cholesterol

    Time frame: From Baseline through Week 12

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

    Time frame: From Baseline through Week 12

  6. Percent change in HDL-C

    Time frame: From Baseline through Week 12

  7. Percent change in triglycerides

    Time frame: From Baseline through Week 12

  8. Percent change in Apolipoprotein B (ApoB)

    Time frame: From Baseline through Week 12

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

    Time frame: Through Week 20

  10. Severity of TEAEs

    Time frame: Through Week 20

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Weekly Alirocumab in Adults With Hypercholesterolemia

Acronym: ASCEND-QW

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 17, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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