Atherosclerotic Cardiovascular DiseaseNCT07615166
Low-Density Lipoprotein Cholesterol Reduction With Alirocumab 150 mg Versus Inclisiran in Individuals Initiating Therapy in Routine Clinical Practice
An observational study of Atherosclerotic Cardiovascular Disease, run by Sanofi at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease
- What is being tested?
- Alirocumab 150 mg and Inclisiran
- How many people
- 996 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Atherosclerotic Cardiovascular Disease
- Being tested
- Alirocumab 150 mg, Inclisiran
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alirocumab 150 mgDrug
The study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.
InclisiranDrug
The study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Alirocumab 150 mg | Participants initiating alirocumab 150 mg were included. Receives: Drug: Alirocumab 150 mg | |
| Inclisiran | Participants receiving Inclisiran were included. Receives: Drug: Inclisiran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percentage Reduction in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline Over the 60 to 450 Days Follow-up
Measured: 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)
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.
Measured: From baseline through 60 to 450 days of follow-up
Variation in Low-Density Lipoprotein Cholesterol (LDL-C) levels Observed Between Participants
Between-participant variability in low-density lipoprotein cholesterol (LDL-C) levels will be summarized using the mid-95% range.
Measured: From baseline through 60 to 450 days of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start22 May 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 996 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615166
- Sponsor's protocol ID
- CEF0218
- Status last verified
- Oct 2026
- First submitted
- 22 May 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction in Low-Density Lipoprotein Cholesterol With Alirocumab 150 mg as Compared With Inclisiran: Comparative Evaluation Via Target-Trial Emulation and G-Computation
- ClinicalTrials.gov ID
- NCT07615166
- Acronym / sponsor ID
- CEF0218
- Conditions
- Atherosclerotic Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 996 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 22 May 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alirocumab 150 mg | – | Drug: Alirocumab 150 mgParticipants initiating alirocumab 150 mg were included. |
| Inclisiran | – | Drug: InclisiranParticipants receiving Inclisiran were included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alirocumab 150 mgThe study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice. | Drug | Alirocumab 150 mg |
| InclisiranThe study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice. | Drug | Inclisiran |
Primary outcome
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
2 secondary outcomes
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
Variation in Low-Density Lipoprotein Cholesterol (LDL-C) levels Observed Between Participants
Time frame: From baseline through 60 to 450 days of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerotic Cardiovascular Disease, run by Sanofi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.