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

NCT07615166 — Completed, 996 participants, Sanofi

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

Registry	NCT07615166
Status	Completed
Study type	Observational
Enrollment	996 (Actual)
Sponsor	Sanofi (Industry)
Conditions	Atherosclerotic Cardiovascular Disease
Interventions	Alirocumab 150 mg, Inclisiran (Drug)
Dates	start 2025-05-22, primary completion 2026-06-30, completion 2026-06-30, first posted 2026-05-29, last updated 2026-10-13
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Alirocumab 150 mg		Drug: Alirocumab 150 mg	Participants initiating alirocumab 150 mg were included.
Inclisiran		Drug: Inclisiran	Participants receiving Inclisiran were included.

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.

+Outcome measures

Primary outcomes

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

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]: 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.
Variation in Low-Density Lipoprotein Cholesterol (LDL-C) levels Observed Between Participants [From baseline through 60 to 450 days of follow-up]: Between-participant variability in low-density lipoprotein cholesterol (LDL-C) levels will be summarized using the mid-95% range.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Sanofi	Bridgewater, New Jersey	United States