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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07615166

Enrollment

996

Registered

2026-05-29

Start date

2025-05-22

Completion date

2026-06-30

Last updated

2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerotic Cardiovascular Disease

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.

Interventions

DRUGAlirocumab 150 mg

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

DRUGInclisiran

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

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Measure	Time frame	Description
Variation in Low-Density Lipoprotein Cholesterol (LDL-C) levels Observed Within the Same Participant	From baseline through 60 to 450 days of follow-up	Within-participant variability in low-density lipoprotein cholesterol (LDL-C) levels will be summarized using the mid-95% range.
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026