How many clinical trials are running for inclisiran?

ClinicalTrials.gov lists more than 16 phase 2–4 inclisiran trials. This page tracks the 16 largest by enrolment: 3 phase 2, 10 phase 3, and 3 phase 4 among them, with 2 actively recruiting. Updated daily.

Are there clinical trials for Leqvio?

Leqvio is the brand name for inclisiran, so inclisiran trials on ClinicalTrials.gov cover it. ClinicalTrials.gov lists more than 16 phase 2–4 inclisiran trials. This page tracks the 16 largest by enrolment: 3 phase 2, 10 phase 3, and 3 phase 4 among them, with 2 actively recruiting. Updated daily.

Where does this data come from?

All trial data is sourced from ClinicalTrials.gov (CTGov) and refreshed on this page daily.

Can I compare inclisiran against other drugs?

Yes. The free ComplyRx Trial Pipeline tool compares up to five drugs side by side on one timeline, with PNG and PDF export. Add any competitor in the search box above.

Lipid & Lp(a) therapies · Live ClinicalTrials.gov data

Inclisiran (Leqvio) clinical trial pipeline

The timeline below tracks the 16 largest phase 2–4 inclisiran (Leqvio) trials on ClinicalTrials.gov by enrolment, 2 of them actively recruiting. The next phase 3 primary completion among them is expected Oct 2026. Refreshed daily. Add up to four competitors to compare pipelines side by side.

16+

Major trials tracked

Phase 3 trials

Actively recruiting

Oct 2026

Next phase 3 primary completion

30,792

Participants across trials

Novartis Pharmaceuticals

Lead sponsor by trial count

inclisiran (16)5 active2016–2034

Hide completed

inclisiran

Key

Actual date

Anticipated

Forecast to primary completion

RecruitingActive, not recruitingCompleted

'16

'18

'20

'22

'24

'26

'28

'30

'32

'34

inclisiran

ORION-1P2

ORION-3P2

ORION-11P3

ORION-9P3

ORION-10P3

ORION-4P3

ORION-8P3

ORION-15P2

Study of Efficacy and Safety of Inclisiran in Asian Participants With Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD High Risk and Elevated Low Density Lipoprotein Cholesterol (LDL-C)P3

V-INCEPTIONP3

SPIRITP3

V-DIFFERENCEP4

V-PLAQUEP3

A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular Disease.P4

PRECADP3

LATAM LOWERS LDL-CP4

Upcoming readouts

4 ahead · inclisiran

Select a trial to load its full ClinicalTrials.gov record.

Key inclisiran trials

Top 12 of the 16 tracked phase 2–4 trials, ordered by phase and status. Trial names open the full ComplyRx trial page; NCT ids link to ClinicalTrials.gov.

Trial	Title	Phase	Status	Primary completion
NCT06501443	LATAM LOWERS LDL-C	Phase 4	Recruiting	Nov 2026
NCT05192941	V-DIFFERENCE: Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, o…	Phase 4	Completed	Jun 2024
NCT06431763	A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Pa…	Phase 4	Completed	Dec 2025
NCT06494501	PRECAD: The Prevent Coronary Artery Disease Trial	Phase 3	Recruiting	Jun 2032
NCT04765657	Study of Efficacy and Safety of Inclisiran in Asian Participants With Atherosclerotic Cardiovasc…	Phase 3	Active, not recruiting	Jun 2022
NCT03705234	ORION-4: A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Ca…	Phase 3	Active, not recruiting	Oct 2026
NCT05360446	V-PLAQUE: Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally T…	Phase 3	Active, not recruiting	Oct 2026
NCT03400800	ORION-11: Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotei…	Phase 3	Completed	Jul 2019
NCT03397121	ORION-9: Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL…	Phase 3	Completed	Aug 2019
NCT03399370	ORION-10: Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density…	Phase 3	Completed	Sept 2019
NCT04807400	SPIRIT: Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support	Phase 3	Completed	Jan 2023
NCT03814187	ORION-8: Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and E…	Phase 3	Completed	Feb 2023

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Get an alert when a trial changes status, moves its completion date, or a new trial registers in scope. Checked nightly against ClinicalTrials.gov.

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FAQ

How many clinical trials are running for inclisiran?: ClinicalTrials.gov lists more than 16 phase 2–4 inclisiran trials. This page tracks the 16 largest by enrolment: 3 phase 2, 10 phase 3, and 3 phase 4 among them, with 2 actively recruiting. Updated daily.
Are there clinical trials for Leqvio?: Leqvio is the brand name for inclisiran, so inclisiran trials on ClinicalTrials.gov cover it. ClinicalTrials.gov lists more than 16 phase 2–4 inclisiran trials. This page tracks the 16 largest by enrolment: 3 phase 2, 10 phase 3, and 3 phase 4 among them, with 2 actively recruiting. Updated daily.
Where does this data come from?: All trial data is sourced from ClinicalTrials.gov (CTGov) and refreshed on this page daily.
Can I compare inclisiran against other drugs?: Yes. The free ComplyRx Trial Pipeline tool compares up to five drugs side by side on one timeline, with PNG and PDF export. Add any competitor in the search box above.

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Key inclisiran trials

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