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OpenTrials
Completed

NCT Number: NCT07615166

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

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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Key information

Conditions

Atherosclerotic Cardiovascular Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

Sanofi

Bridgewater, New Jersey, 08807, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 29, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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