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

Reduction in Low-Density Lipoprotein Cholesterol With Alirocumab 150 mg as Compared With Inclisiran: Comparative Evaluation Via Target-Trial Emulation and G-Computation

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atherosclerotic Cardiovascular Disease
• Intervention / Treatment: Drug: Alirocumab 150 mg; Drug: Inclisiran

• Study Type: Observational
• Enrollment (Estimated): 124

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • Sanofi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults (>= 18 years) initiating alirocumab 150 mg or inclisiran among adults eligible for proprotein convertase subtilisin/kexin type 9 (PCSK9) -targeting therapy in routine practice: from January 2016 to July 2024.

Description

Inclusion Criteria:

• Participants initiating alirocumab 150 mg or inclisiran.
• Participants with at least once LDL-C measurement during 365 days before index.
• Participants who continuously enrolled in medical and pharmacy benefits for at least 365 days pre index.

Exclusion Criteria:

• Participants with unknown sex, geographic region, or insurance type, and age < 18 years at index.
• Participants with exposure to evolocumab before index.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Alirocumab 150 mg; Participants initiating alirocumab 150 mg were included.	Drug: Alirocumab 150 mg; The study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.
Inclisiran; Participants receiving Inclisiran were included.	Drug: Inclisiran; The study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Number of Days With Low-Density Lipoprotein Cholesterol (LDL-C) Less Than 70 mg/dL (1.8 mmol/L)	Total number of days during which a participant's LDL-C level will remain below 70 mg/dL (1.8 mmol/L) will be reported.	From baseline through 60 to 450 days of follow-up
Variation in Low-Density Lipoprotein Cholesterol (LDL-C) levels Observed Within the Same Participant	Within-participant variability in low-density lipoprotein cholesterol (LDL-C) levels will be summarized using the mid-95% range.	From baseline through 60 to 450 days of follow-up

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; alirocumab; ALN-PCS
• Other Study ID Numbers: CEF0218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No