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

NCT07615166 | Completed FDA Drug

• 1 other identifier: CEF0218
• Study Type: observational
• Target: 996
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atherosclerotic Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cumulative Number of Days With Low-Density Lipoprotein Cholesterol (LDL-C) Less Than 70 mg/dL (1.8 mmol/L)

  From baseline through 60 to 450 days of follow-up

• Variation in Low-Density Lipoprotein Cholesterol (LDL-C) levels Observed Within the Same Participant

  From baseline through 60 to 450 days of follow-up

Study Arms (2)

Alirocumab 150 mg

Participants initiating alirocumab 150 mg were included.

Drug: Alirocumab 150 mg

Inclisiran

Participants receiving Inclisiran were included.

Drug: Inclisiran

Interventions

Alirocumab 150 mg DRUG

The study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.

Alirocumab 150 mg

Inclisiran DRUG

The study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.

Inclisiran

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Atherosclerosis

Interventions

alirocumab; ALN-PCS

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: May 22, 2025
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)