Low-Density Lipoprotein Cholesterol Reduction With Alirocumab 150 mg Versus Inclisiran in Individuals Initiating Therapy in Routine Clinical Practice

Part of paid clinical trials in Bridgewater, New Jersey.

Sponsor
Sanofi
Study ID
NCT07615166
Status
Active Not Recruiting

Conditions

  • Atherosclerotic Cardiovascular Disease

Eligibility Criteria

Sex
MALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Alirocumab 150 mg — DRUG
    The study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.
  • Inclisiran — DRUG
    The study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.

Study Details

The objective of this study is to evaluate LDL-C reduction over time among individuals initiating alirocumab 150 mg compared with inclisiran in routine clinical practice. The study will leverage observational data reflective of routine care and apply contemporary methods in target trial emulation and causal inference to estimate comparative treatment effects.

Key Dates

Start date
May 22, 2025
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
124 participants (estimated)

Arms

  • Arm: Alirocumab 150 mg
    Participants initiating alirocumab 150 mg were included.
  • Arm: Inclisiran
    Participants receiving Inclisiran were included.

Primary Outcome Measure

Mean Percentage Reduction in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline Over the 60 to 450 Days Follow-up [ Time Frame: From baseline through 60 to 450 days of follow-up ]

Locations (1)

FacilityCityStateZIPSite coordinators
SanofiBridgewaterNew Jersey08807-

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By research site
Sanofi· Bridgewater, NJ

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