How many Inclisiran clinical trials are there?

46 Inclisiran clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 13 are actively recruiting participants. 22 are marked completed.

Are Inclisiran clinical trials recruiting in 2026?

Yes — 13 Inclisiran trials are actively recruiting in 2026, with 150 U.S. sites across 37 states. See the recruiting trials and the per-state site list further down this page.

What conditions is Inclisiran being studied for?

Inclisiran is being studied for Atherosclerotic Cardiovascular Disease, Hypercholesterolemia, Elevated Cholesterol, Acute Coronary Syndrome, ASCVD and 38 more. The trials are grouped by indication on this page.

What phase is Inclisiran in?

Inclisiran clinical trials span 11 Phase 4, 24 Phase 3, 3 Phase 2, 2 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.

Who sponsors Inclisiran clinical trials?

The lead sponsor across the most Inclisiran trials is Novartis Pharmaceuticals, with 14 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.

Inclisiran Clinical Trials (2026): 46 Studies for Atherosclerotic Cardiovascular Disease & Hypercholesterolemia

Creator: Hipa.ai Research
Published: 2026-05-07T20:05:08.298Z

Hipa.ai Research · Source: ClinicalTrials.gov / AACT

Synced daily from ClinicalTrials.gov via AACT. Last sync: June 18, 2026.

46 Inclisiran clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 24 indications (including Atherosclerotic Cardiovascular Disease & Hypercholesterolemia) and 282,119 total planned enrollment. 24 Phase 3 Inclisiran trials and 3 Phase 2, 11 Phase 4 are listed. 16 Inclisiran clinical trials are actively recruiting at 150 U.S. sites across 37 states. Most recent activity: NCT03705234 (Dec 2049).

Where to Participate: All Inclisiran Trial Sites in the U.S. (150 sites across 37 states)

Every actively recruiting Inclisirantrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.

State	Facility	City	Trial	Map
AL	Advanced Cardiovascular LLC	Alexander City35010	NCT06909565	Map
AL	Cardiology, PC	Birmingham35211	NCT06909565	Map
AL	Parkway Medical Center	Birmingham35215	NCT06813911	Map
AL	Heart Center Research, LLC	Huntsville35801	NCT06909565	Map
AZ	Clinical Research Inst of Arizona	Sun City West85375	NCT06813911	Map
AR	Arkansas Cardiology	Little Rock72205	NCT06909565	Map
CA	National Heart Institute	Beverly Hills90211	NCT06813911	Map
CA	Pacific Oaks Medical Group	Beverly Hills90211	NCT06909565	Map
CA	UC San Diego Altman Clinical and Translational Research Institute	La Jolla92037	NCT06865885	Map
CA	Radin Cardiovascular Medical Group, Inc	Newport Beach92663	NCT06909565	Map
CA	Valley Clinical Trials, LLC - Flourish Research	Northridge91325	NCT06909565	Map
CA	Riverside Community Hospital	Riverside92501	NCT06909565	Map
CA	San Diego Cardiac Center	San Diego92123	NCT06909565	Map
CA	UC San Francisco Medical Center	San Francisco94143	NCT06597006	Map
CA	UC San Francisco Medical Center	San Francisco94143	NCT06597006	Map
CA	UC San Francisco Medical Center	San Francisco94143-0348	NCT06597019	Map
CA	UC San Francisco Medical Center	San Francisco94143	NCT06597019	Map
CA	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Torrance90502	NCT06909565	Map
CA	The Heart Medical Group	Van Nuys91406	NCT06909565	Map
CA	FOMAT - West Coast Research Center	Ventura93030	NCT06909565	Map
CA	Interv Cardiology Med Grp	West Hills91307	NCT06813911	Map
CA	Interventional Cardiology Medical Group	West Hills91307	NCT06909565	Map
CT	Bridgeport Hospital	Bridgeport06610	NCT06909565	Map
CT	Nuvance Health- Danbury Hospital	Danbury06810	NCT06909565	Map
CT	Cardiology Associates of Fairfield County	Stamford06305	NCT06909565	Map
DC	Childrens National Hospital	Washington D.C.20010	NCT06597006	Map
DC	Childrens National Hospital	Washington D.C.20010	NCT06597019	Map
FL	Excel Medical Clinical Trials LLC	Boca Raton33434	NCT06597019	Map
FL	BayCare Medical Group	Clearwater33756	NCT06909565	Map
FL	Clearwater Cardiovascular Consultants	Clearwater33756	NCT06909565	Map
FL	Pioneer Clinical Studies	Coral Gables33134	NCT06909565	Map
FL	Arrow Clinical Trails	Daytona Beach32117	NCT06909565	Map
FL	Jacksonville Center for Clinical	Jacksonville32216	NCT06813911	Map
FL	Clearwater Cardiovascular and Interventional Consultants- Bardmoor	Largo33777	NCT06909565	Map
FL	Baptist Health South	Miami33173	NCT06813911	Map
FL	University of Miami Hospital	Miami33136	NCT06813911	Map
FL	Inpatient Research Clinic, LLC	Miami Lakes33014	NCT06909565	Map
FL	FXM Clin Res Miramar LLC	Miramar33027	NCT06813911	Map
FL	Ocala Cardiovascular Research	Ocala34471	NCT06813911	Map
FL	Cardiovascular Institute of Northwest Florida	Panama City32405	NCT06909565	Map
FL	SEC Clinical Research	Pensacola32503	NCT06813911	Map
FL	Charlotte Heart & Vascular Center, PA	Port Charlotte33948	NCT06909565	Map
FL	Peace River Cardiovascular Center	Port Charlotte33952	NCT06813911	Map
FL	Clearwater Cardiovascular Consultants	Safety Harbor34695	NCT06909565	Map
FL	Tampa Cardiovascular Interventions and Research	Tampa33614	NCT06909565	Map
FL	University Of South Florida	Tampa33612	NCT06813911	Map
FL	FC Site Partners Miami	Winter Park32789	NCT06813911	Map
GA	Northeast Georgia Heart Center, PC	Gainesville30501	NCT06909565	Map
GA	Javara, Inc.	Peachtree City30269	NCT06909565	Map
GA	Atlanta Heart Specialists LLC	Tucker30084	NCT06909565	Map
IL	Advocate Lutheran General Childrens Hospital	Park Ridge60068	NCT06813911	Map
IN	Midwest Cardiovascular Research and Education Foundation	Elkhart46514	NCT06909565	Map
IN	American Health Network Research Dept	Muncie47304	NCT06813911	Map
IN	American Health Network Research Dept	Muncie47304	NCT06813911	Map
IN	Reid Physician Associates	Richmond47374	NCT06909565	Map
IA	Iowa Heart Center	West Des Moines50266	NCT06909565	Map
KS	Midwest Heart and Vascular Specialists	Overland Park66211	NCT06909565	Map
KY	Research Integrity, LLC	Owensboro42303	NCT06909565	Map
LA	Grace Research, LLC	Bossier City71111	NCT06909565	Map
LA	Cardiovascular Associates Research	Covington70433	NCT06813911	Map
LA	Louisiana Heart Center	Covington70433	NCT06909565	Map
LA	Omega Clinical Research	Metairie70006	NCT06813911	Map
LA	Tulane School of Medicine	New Orleans70112	NCT06909565	Map
LA	Cardiovascular Solutions, LLC	Shreveport71103	NCT06909565	Map
LA	Monroe Research LLC	West Monroe71291	NCT06909565	Map
ME	Northern Light Eastern Maine Medical Center	Bangor04401	NCT06909565	Map
MD	Flourish Research Bowie	Bowie20715	NCT06813911	Map
MD	Anderson Medical Research	Ft. Washington20744	NCT06813911	Map
MD	Capitol Cardiology Associates PA	Lanham20706	NCT06909565	Map
MD	Shady Grove Adventist Hospital	Rockville20850	NCT06909565	Map
MD	TidalHealth Peninsula Regional	Salisbury21804	NCT06909565	Map
MD	Jadestone Clinical Research, LLC	Silver Spring20904	NCT06909565	Map
MI	Henry Ford Hospital	Detroit48202	NCT06813911	Map
MI	Aa Mrc Llc	Flint48504	NCT06813911	Map
MI	UMH-Sparrow Clinical Research Institute	Lansing48912	NCT06909565	Map
MI	MyMichigan Medical Center Midland	Midland48670	NCT06813911	Map
MI	MyMichigan Medical Center Midland	Midland48670	NCT06909565	Map
MI	Healthy Heart Cardiology at Rochester Hills (Advanced Cardiology Associates	Rochester Hills48307	NCT06909565	Map
MN	Aspirus Saint Luke's Hospital	Duluth55805	NCT06909565	Map
MN	Essentia Health-SMMC	Duluth55805	NCT06909565	Map
MN	JAVARA Inc, - Mankato Clinic	Mankato56001	NCT06909565	Map
MS	Stern Cardiovascular	Southaven38671	NCT06909565	Map
MS	Cardiology Associates of North Mississippi	Tupelo38801	NCT06909565	Map
MO	Washington Univ School Of Medicine	St Louis63110	NCT06597006	Map
NE	CHI Health Nebraska Heart	Grand Island68803	NCT06909565	Map
NE	Bryan Heart	Lincoln68506	NCT06909565	Map
NE	CHI Health Nebraska Heart	Lincoln68526	NCT06909565	Map
NE	Methodist Physicians Clinic Heart Consultants	Omaha68114	NCT06909565	Map
NV	AB Clinical Trials	Las Vegas89119	NCT06813911	Map
NH	Dartmouth-Hitchcock Medical Center	Lebanon03756	NCT06909565	Map
NJ	Advanced Heart Care LLC	Bridgewater08807	NCT06909565	Map
NJ	Cardiovascular Associates of the Delaware Valley	Elmer08318	NCT06909565	Map
NJ	Advanced Heart and Vascular Institute Of Hunterdon	Flemington08822	NCT06909565	Map
NJ	Cardiovascular Associates of the Delaware Valley	Haddon Heights08035	NCT06909565	Map
NJ	AtlantiCare Regional Medical Center	Pomona08240	NCT06909565	Map
NJ	Cardiovascular Associates of the Delaware Valley	Sewell08080	NCT06909565	Map
NJ	Overlook Medical Center	Summit07901	NCT06813911	Map
NY	Capital Cardiology Associates	Albany12211	NCT06909565	Map
NY	Sisters of Charity Hospital	Buffalo14214	NCT06909565	Map
NY	Trinity Medical WNY, PC	Buffalo14214	NCT06909565	Map
NY	Icahn School of Med at Mt Sinai	New York10029	NCT06597019	Map
NY	Mount Sinai Fuster Heart Hospital	New York10029	NCT06494501	Map
NY	Mount Sinai School of Medicine	New York10029	NCT06909565	Map
NY	Hudson Valley Cardiovascular Practice PC	Poughkeepsie12601	NCT06909565	Map
NY	Richmond University Medical Center	Staten Island10310	NCT06909565	Map
NC	Asheville Cardiology Associates Research Department	Asheville28803	NCT06909565	Map
NC	Mecklenburg Heart Specialists	Charlotte28207	NCT06909565	Map
NC	Novant Health Clinical Research/Heart & Vascular Institute	Charlotte28204	NCT06909565	Map
NC	Javara Inc.	Fayetteville28304	NCT06909565	Map
NC	Duke Cardiology	Morrisville27560	NCT06909565	Map
NC	Wake Forest University Baptist Medical Center	Winston-Salem27157	NCT06813911	Map
OH	Aultman Hospital	Canton44710	NCT06909565	Map
OH	Heart House Research Foundation LLC	Springfield45505	NCT06909565	Map
OH	Genesis HealthCare System	Zanesville43701	NCT06909565	Map
OK	South Oklahoma Heart Research, LLC	Oklahoma City73135	NCT06909565	Map
OR	The Corvallis Clinic P C	Corvallis97330	NCT06813911	Map
PA	Capital Area Research LLC	Camp Hill17011	NCT06909565	Map
PA	Wellspan Chambersburg Hospital	Chambersburg17201	NCT06909565	Map
PA	Penn Lancaster General Health Research Institute	Lancaster17602	NCT06909565	Map
PA	Cardiology Associates of West Reading	West Reading19611	NCT06909565	Map
PA	WellSpan Heart and Vascular Research	York17403	NCT06909565	Map
SC	AnMed Health Medical Center	Anderson29621	NCT06909565	Map
TN	Stern Cardiovascular Center	Germantown38138	NCT06909565	Map
TN	Apex Research Foundation, LLC	Jackson38301	NCT06909565	Map
TN	TriStar Centennial Medical Center	Nashville37203	NCT06909565	Map
TN	Novartis Investigative Site	Tullahoma37388	NCT06813911	Map
TX	Amarillo Heart Clinical Research Institute, Inc.	Amarillo79124	NCT06909565	Map
TX	PharmaTex Research	Amarillo79106	NCT06909565	Map
TX	PharmaTex Research LLC	Amarillo79106	NCT06813911	Map
TX	Austin Heart	Austin78705	NCT06909565	Map
TX	Javara inc.	Conroe77384	NCT06909565	Map
TX	Kelsey Seybold Research Foundation	Houston77030	NCT06813911	Map
TX	Texas Cardiology Associates of Houston	Kingwood77339	NCT06909565	Map
TX	Heart Institute of East Texas	Lufkin75904	NCT06909565	Map
TX	Austin Heart PLLC	Round Rock78681	NCT06909565	Map
TX	Austin Heart	San Marcos78666	NCT06909565	Map
TX	Northwest Houston Clinical Research PLLC	Tomball77375	NCT06813911	Map
TX	Northwest Houston Heart Center	Tomball77375	NCT06909565	Map
TX	Viva Heart and Vein	Tomball77375	NCT06909565	Map
UT	Intermountain Medical Center	Murray84107	NCT06813911	Map
UT	Primary Childrens Medical Center	Salt Lake City84113	NCT06597019	Map
VA	Virginia Heart	Falls Church22042	NCT06813911	Map
VA	TPMG Clinical Research	Newport News23606	NCT06909565	Map
VA	Chippenham Hospital	Richmond23225	NCT06909565	Map
VA	Virginia Commonwealth University	Richmond23298	NCT06597019	Map
VA	Winchester Cardiology and Vascular Medicine	Winchester22601	NCT06909565	Map
WA	MultiCare Institute for Research and Innovation	Puyallup98372	NCT06909565	Map
WA	MultiCare Institute for Research and Innovation	Tacoma98405	NCT06909565	Map
WV	West Virginia Childrens Hospital	Morgantown26506	NCT06597019	Map
WV	West Virginia Childrens Hospital	Morgantown26506	NCT06597019	Map

Inclisiran clinical trials at a glance: phase × recruitment status

Phase	recruiting	active not recruiting	completed	not yet recruiting	unknown	Total
P1			2			2
P2			3			3
P3	6	5	13			24
P4	4	2	3	2		11
N/A	3		1	1	1	6

Recruiting Inclisiran clinical trials (16)

Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).

NCT ID	Title	Phase	Indication	Enrollment	Started
NCT06494501	PRECADThe Prevent Coronary Artery Disease Trial	P3	Atherosclerotic Cardiovascular Disease	1,600	Sep 2024
NCT05682378	V-PEDS-OLELong-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Pediatric ORION-16, ORION-13, ORION-20, or ORION-19 Studies	P3	Heterozygous or Homozygous Familial Hypercholesterolemia	195	Feb 2023
NCT06287177	CHOLINETMulticenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy	—	Hypercholesterolemia	3,000	Nov 2022
NCT06909565	V-INTERVENTIONInclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention	P4	Percutaneous Coronary Intervention	6,000	Jul 2025
NCT06597006	ORION-19Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia	P3	Familial Hypercholesterolemia - Homozygous	9	Feb 2025
NCT06597019	ORION-20Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia	P3	Familial Hypercholesterolemia - Heterozygous	60	Dec 2024
NCT06813911	ADD-VANTAGELp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD	P3	Atherosclerotic Cardiovascular Disease (ASCVD)	340	Apr 2025
NCT06858332	STaRTLipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia	—	Atherosclerotic Cardiovascular Disease	2,382	Apr 2025
NCT06421363	CAPRICIContinuity of Care Between Primary Care Cardiology and Specialty Services for Patients With Chronic Ischemic Heart Disease	P4	Ischemic Heart Disease	50	Jun 2024
NCT07102628	ACSEvaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes	P3	Acute Coronary Syndrome	300	Oct 2025
NCT06372925	V-ACCELERATEIntravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction	P4	Plaque, Atherosclerotic	318	Jul 2024
NCT06865885	SOLVE-LDL-CLDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering	P4	Drug Interactions	100	Apr 2025
NCT05587621	GoTIntensive Lipid-lowering in Patients With STEMI and NSTEMI (Germany on Target)	N/A	ST Elevation Myocardial Infarction	300	Apr 2024
NCT06586684	Effect of Small Interfering RNA Inclisiran on Carotid Plaques As Assessed by Carotid Ultrasound	P4	Carotid Plaque	40	Sep 2024
NCT04073797	PIILLPET Imaging of Inflammation and Lipid Lowering Study	N/A	Hypercholesterolemia	63	Mar 2023
NCT06338293	EItoCVPEffects of Inclisiran Combined With Statins on the Morphology of Coronary Vulnerable Plaques	P4	Coronary Artery Disease	40	Mar 2024

Inclisiran clinical trials by indication

Atherosclerotic Cardiovascular Disease (10)

NCT	Acronym	Phase	Status	Title
NCT03705234	ORION-4	P3	active not recruiting	A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease
NCT06494501	PRECAD	P3	recruiting	The Prevent Coronary Artery Disease Trial
NCT05030428	VICTORION-2P	P3	active not recruiting	Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease
NCT06858332	STaRT	N/A	recruiting	Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia
NCT06249165	V-INCLUSION	P4	active not recruiting	VictORION-INCLUSION: Evaluating Inclisiran for Cholesterol Managment in Heart Disease
NCT05639218	—	N/A	unknown	Impact of Optimal Pharmacotherapy on Lipid Profile and Qualitative Features of Atherosclerotic Plaques
NCT05974345	SIRIUS	N/A	completed	In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Disease
NCT04929249	V-INITIATE	P3	completed	A Randomized Study to Evaluate the Effect of an "Inclisiran First" Implementation Strategy Compared to Usual Care in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE)
+ 2 more, see All trials below.

Hypercholesterolemia (8)

NCT	Acronym	Phase	Status	Title
NCT06287177	CHOLINET	N/A	recruiting	Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy
NCT04765657	ASCVD	P3	active not recruiting	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)
NCT04073797	PIILL	N/A	recruiting	PET Imaging of Inflammation and Lipid Lowering Study
NCT06431763	—	P4	completed	A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular Disease.
NCT05192941	V-DIFFERENCE	P4	completed	Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipid-lowering Therapy, in Participants With Hypercholesterolemia
NCT05004675	LIBerate-VI	P3	completed	Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients
NCT05763875	V-Mono	P3	completed	Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.
NCT04666298	ORION-15	P2	completed	Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C

ASCVD (3)

NCT	Acronym	Phase	Status	Title
NCT03814187	ORION-8	P3	completed	Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C
NCT03399370	ORION-10	P3	completed	Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol
NCT03400800	ORION-11	P3	completed	Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol

Acute Coronary Syndrome (2)

NCT	Acronym	Phase	Status	Title
NCT07102628	ACS	P3	recruiting	Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes
NCT04873934	V-INCEPTION	P3	completed	Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome

Familial Hypercholesterolemia - Homozygous (2)

NCT	Acronym	Phase	Status	Title
NCT06597006	ORION-19	P3	recruiting	Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
NCT04659863	ORION-13	P3	completed	Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia

Familial Hypercholesterolemia - Heterozygous (2)

NCT	Acronym	Phase	Status	Title
NCT06597019	ORION-20	P3	recruiting	Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia
NCT04652726	ORION-16	P3	completed	Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia

Coronary Artery Disease (2)

NCT	Acronym	Phase	Status	Title
NCT05360446	V-PLAQUE	P3	active not recruiting	Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
NCT06338293	EItoCVP	P4	recruiting	Effects of Inclisiran Combined With Statins on the Morphology of Coronary Vulnerable Plaques

Percutaneous Coronary Intervention (1)

NCT	Acronym	Phase	Status	Title
NCT06909565	V-INTERVENTION	P4	recruiting	Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention

Coronary Heart Disease (1)

NCT	Acronym	Phase	Status	Title
NCT06941792	V-INVINCIBLE	P4	active not recruiting	Inclisiran Effectiveness in China: a Pragmatic Randomized Trial

Atherosclerotic Cardiovascular Disease (ASCVD) (1)

NCT	Acronym	Phase	Status	Title
NCT06813911	ADD-VANTAGE	P3	recruiting	Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD

Drug Interactions (1)

NCT	Acronym	Phase	Status	Title
NCT06865885	SOLVE-LDL-C	P4	recruiting	LDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering

Hypercholesterolemia and Mixed Hyperlipidemia (1)

NCT	Acronym	Phase	Status	Title
NCT07421232	—	P2	completed	A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia

Primary Hypercholesterolemia (1)

NCT	Acronym	Phase	Status	Title
NCT06386419	—	P4	completed	A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

Carotid Plaque (1)

NCT	Acronym	Phase	Status	Title
NCT06586684	—	P4	not yet recruiting	Effect of Small Interfering RNA Inclisiran on Carotid Plaques As Assessed by Carotid Ultrasound

Plaque, Atherosclerotic (1)

NCT	Acronym	Phase	Status	Title
NCT06372925	V-ACCELERATE	P4	recruiting	Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction

Ischemic Heart Disease (1)

NCT	Acronym	Phase	Status	Title
NCT06421363	CAPRICI	P4	not yet recruiting	Continuity of Care Between Primary Care Cardiology and Specialty Services for Patients With Chronic Ischemic Heart Disease

ST Elevation Myocardial Infarction (1)

NCT	Acronym	Phase	Status	Title
NCT05587621	GoT	N/A	not yet recruiting	Intensive Lipid-lowering in Patients With STEMI and NSTEMI (Germany on Target)

Primary Hypercholesterolemia or Mixed Dyslipidemia (1)

NCT	Acronym	Phase	Status	Title
NCT05888103	V-Mono China	P3	completed	Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol.

Primary Prevention of Atherosclerotic Cardiovascular Disease (1)

NCT	Acronym	Phase	Status	Title
NCT05739383	—	P3	active not recruiting	A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.

Heterozygous or Homozygous Familial Hypercholesterolemia (1)

NCT	Acronym	Phase	Status	Title
NCT05682378	V-PEDS-OLE	P3	recruiting	Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Pediatric ORION-16, ORION-13, ORION-20, or ORION-19 Studies

Hyperlipidemia (1)

NCT	Acronym	Phase	Status	Title
NCT04774003	ORION-14	P1	completed	Study of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inclisiran in Chinese Participants With Elevated Serum LDL-C

Homozygous Familial Hypercholesterolemia (1)

NCT	Acronym	Phase	Status	Title
NCT03851705	ORION-5	P3	completed	A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

Heterozygous Familial Hypercholesterolemia (1)

NCT	Acronym	Phase	Status	Title
NCT03397121	ORION-9	P3	completed	Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH)

Renal Impairment (1)

NCT	Acronym	Phase	Status	Title
NCT03159416	ORION-7	P1	completed	A Study of Inclisiran in Participants With Renal Impairment Compared to Participants With Normal Renal Function (ORION-7)

Inclisiran pivotal trial highlights (Phase 2/3/4)

Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.

Acronym	NCT	Phase	Status	Indication	Enrollment	PubMed
V-INTERVENTION	NCT06909565	P4	recruiting	Percutaneous Coronary Intervention	6,000	PMID 38972336
CAPRICI	NCT06421363	P4	not yet recruiting	Ischemic Heart Disease	50	—
V-INVINCIBLE	NCT06941792	P4	active not recruiting	Coronary Heart Disease	1,590	—
V-INCLUSION	NCT06249165	P4	active not recruiting	Atherosclerotic Cardiovascular Disease	130	—
V-ACCELERATE	NCT06372925	P4	recruiting	Plaque, Atherosclerotic	318	—
SOLVE-LDL-C	NCT06865885	P4	recruiting	Drug Interactions	100	PMID 27754879
EItoCVP	NCT06338293	P4	recruiting	Coronary Artery Disease	40	—
V-DIFFERENCE	NCT05192941	P4	completed	Hypercholesterolemia	1,770	PMID 40436308
ORION-4	NCT03705234	P3	active not recruiting	Atherosclerotic Cardiovascular Disease	16,124	—
PRECAD	NCT06494501	P3	recruiting	Atherosclerotic Cardiovascular Disease	1,600	—
V-PEDS-OLE	NCT05682378	P3	recruiting	Heterozygous or Homozygous Familial Hypercholesterolemia	195	—
ORION-19	NCT06597006	P3	recruiting	Familial Hypercholesterolemia - Homozygous	9	—
ORION-20	NCT06597019	P3	recruiting	Familial Hypercholesterolemia - Heterozygous	60	—
ADD-VANTAGE	NCT06813911	P3	recruiting	Atherosclerotic Cardiovascular Disease (ASCVD)	340	—
VICTORION-2P	NCT05030428	P3	active not recruiting	Atherosclerotic Cardiovascular Disease	17,004	—
ACS	NCT07102628	P3	recruiting	Acute Coronary Syndrome	300	—
ASCVD	NCT04765657	P3	active not recruiting	Hypercholesterolemia	345	PMID 38371290
V-PLAQUE	NCT05360446	P3	active not recruiting	Coronary Artery Disease	608	PMID 40769373
ORION-16	NCT04652726	P3	completed	Familial Hypercholesterolemia - Heterozygous	141	PMID 41616799
ORION-13	NCT04659863	P3	completed	Familial Hypercholesterolemia - Homozygous	13	PMID 40391436
V-Mono China	NCT05888103	P3	completed	Primary Hypercholesterolemia or Mixed Dyslipidemia	207	—
LIBerate-VI	NCT05004675	P3	completed	Hypercholesterolemia	166	—
V-INCEPTION	NCT04873934	P3	completed	Acute Coronary Syndrome	400	—
V-Mono	NCT05763875	P3	completed	Hypercholesterolemia	350	PMID 40392667
V-INITIATE	NCT04929249	P3	completed	Atherosclerotic Cardiovascular Disease	450	PMID 38593947
ORION-8	NCT03814187	P3	completed	ASCVD	3,275	PMID 38753448
SPIRIT	NCT04807400	P3	completed	Atherosclerotic Cardiovascular Disease	892	PMID 40010816
ORION-5	NCT03851705	P3	completed	Homozygous Familial Hypercholesterolemia	56	PMID 37850379
ORION-10	NCT03399370	P3	completed	ASCVD	1,561	PMID 37282500
ORION-9	NCT03397121	P3	completed	Heterozygous Familial Hypercholesterolemia	482	PMID 32197277
ORION-11	NCT03400800	P3	completed	ASCVD	1,617	PMID 39093262
ORION-15	NCT04666298	P2	completed	Hypercholesterolemia	312	—
ORION-3	NCT03060577	P2	completed	Atherosclerotic Cardiovascular Disease	382	PMID 36620965

All Inclisiran trials (46)

Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.

NCT ID	Acronym	Title	Phase	Status	Enrollment	Sponsor	Started
NCT03705234	ORION-4	A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease	P3	active not recruiting	16,124	University of Oxford	Oct 2018
NCT06494501	PRECAD	The Prevent Coronary Artery Disease Trial	P3	recruiting	1,600	Icahn School of Medicine at Mount Sinai	Sep 2024
NCT05682378	V-PEDS-OLE	Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Pediatric ORION-16, ORION-13, ORION-20, or ORION-19 Studies	P3	recruiting	195	Novartis Pharmaceuticals	Feb 2023
NCT06287177	CHOLINET	Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy	—	recruiting	3,000	Federico II University	Nov 2022
NCT06909565	V-INTERVENTION	Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention	P4	recruiting	6,000	Duke University	Jul 2025
NCT05739383		A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.	P3	active not recruiting	14,012	Novartis Pharmaceuticals	Mar 2023
NCT06597006	ORION-19	Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia	P3	recruiting	9	Novartis Pharmaceuticals	Feb 2025
NCT06597019	ORION-20	Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia	P3	recruiting	60	Novartis Pharmaceuticals	Dec 2024
NCT06813911	ADD-VANTAGE	Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD	P3	recruiting	340	Novartis Pharmaceuticals	Apr 2025
NCT05030428	VICTORION-2P	Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease	P3	active not recruiting	17,004	Novartis Pharmaceuticals	Nov 2021
NCT06858332	STaRT	Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia	—	recruiting	2,382	Novartis Pharmaceuticals	Apr 2025
NCT06421363	CAPRICI	Continuity of Care Between Primary Care Cardiology and Specialty Services for Patients With Chronic Ischemic Heart Disease	P4	not yet recruiting	50	Jose Seijas Amigo	Jun 2024
NCT06941792	V-INVINCIBLE	Inclisiran Effectiveness in China: a Pragmatic Randomized Trial	P4	active not recruiting	1,590	Novartis Pharmaceuticals	Jun 2025
NCT06249165	V-INCLUSION	VictORION-INCLUSION: Evaluating Inclisiran for Cholesterol Managment in Heart Disease	P4	active not recruiting	130	Duke University	Dec 2024
NCT07102628	ACS	Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes	P3	recruiting	300	Novartis Pharmaceuticals	Oct 2025
NCT06372925	V-ACCELERATE	Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction	P4	recruiting	318	Novartis Pharmaceuticals	Jul 2024
NCT06865885	SOLVE-LDL-C	LDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering	P4	recruiting	100	University of California, San Diego	Apr 2025
NCT05587621	GoT	Intensive Lipid-lowering in Patients With STEMI and NSTEMI (Germany on Target)	N/A	not yet recruiting	300	Jena University Hospital	Apr 2024
NCT04765657	ASCVD	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	active not recruiting	345	Novartis Pharmaceuticals	Mar 2021
NCT05360446	V-PLAQUE	Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events	P3	active not recruiting	608	Novartis Pharmaceuticals	Jul 2022
NCT06586684		Effect of Small Interfering RNA Inclisiran on Carotid Plaques As Assessed by Carotid Ultrasound	P4	not yet recruiting	40	First Affiliated Hospital of Xinjiang Medical University	Sep 2024
NCT04073797	PIILL	PET Imaging of Inflammation and Lipid Lowering Study	N/A	recruiting	63	University of Cambridge	Mar 2023
NCT07421232		A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia	P2	completed	156	CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.	Dec 2024
NCT06386419		A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia	P4	completed	65	Novartis Pharmaceuticals	Nov 2024
NCT06431763		A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular Disease.	P4	completed	402	Novartis Pharmaceuticals	Jun 2024
NCT06338293	EItoCVP	Effects of Inclisiran Combined With Statins on the Morphology of Coronary Vulnerable Plaques	P4	recruiting	40	Nanjing First Hospital, Nanjing Medical University	Mar 2024
NCT05192941	V-DIFFERENCE	Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipid-lowering Therapy, in Participants With Hypercholesterolemia	P4	completed	1,770	Novartis Pharmaceuticals	Apr 2022
NCT04652726	ORION-16	Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia	P3	completed	141	Novartis Pharmaceuticals	Jan 2021
NCT04659863	ORION-13	Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia	P3	completed	13	Novartis Pharmaceuticals	Feb 2021
NCT05888103	V-Mono China	Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol.	P3	completed	207	Novartis Pharmaceuticals	Jul 2023
NCT05004675	LIBerate-VI	Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients	P3	completed	166	LIB Therapeutics LLC	Jun 2022
NCT04873934	V-INCEPTION	Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome	P3	completed	400	Novartis Pharmaceuticals	Jun 2021
NCT05763875	V-Mono	Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.	P3	completed	350	Novartis Pharmaceuticals	Mar 2023
NCT05639218		Impact of Optimal Pharmacotherapy on Lipid Profile and Qualitative Features of Atherosclerotic Plaques	—	unknown	50	Pauls Stradins Clinical University Hospital	Jun 2021
NCT05974345	SIRIUS	In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Disease	—	completed	204,691	Novartis Pharmaceuticals	Nov 2023
NCT04929249	V-INITIATE	A Randomized Study to Evaluate the Effect of an "Inclisiran First" Implementation Strategy Compared to Usual Care in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE)	P3	completed	450	Novartis Pharmaceuticals	Jun 2021
NCT03814187	ORION-8	Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C	P3	completed	3,275	Novartis Pharmaceuticals	Apr 2019
NCT04807400	SPIRIT	Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support	P3	completed	892	Novartis Pharmaceuticals	Jul 2021
NCT04666298	ORION-15	Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C	P2	completed	312	Novartis Pharmaceuticals	Jan 2021
NCT03060577	ORION-3	An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol	P2	completed	382	Novartis Pharmaceuticals	Apr 2017
NCT04774003	ORION-14	Study of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inclisiran in Chinese Participants With Elevated Serum LDL-C	P1	completed	40	Novartis Pharmaceuticals	Feb 2021
NCT03851705	ORION-5	A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH)	P3	completed	56	Novartis Pharmaceuticals	Feb 2019
NCT03399370	ORION-10	Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol	P3	completed	1,561	The Medicines Company	Dec 2017
NCT03397121	ORION-9	Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH)	P3	completed	482	The Medicines Company	Nov 2017
NCT03400800	ORION-11	Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol	P3	completed	1,617	The Medicines Company	Nov 2017
NCT03159416	ORION-7	A Study of Inclisiran in Participants With Renal Impairment Compared to Participants With Normal Renal Function (ORION-7)	P1	completed	31	The Medicines Company	Jun 2017

Inclisiran clinical trials: frequently asked questions

How many Inclisiran clinical trials are there?: 46 Inclisiran clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 13 are actively recruiting participants. 22 are marked completed.
Are Inclisiran clinical trials recruiting in 2026?: Yes — 13 Inclisiran trials are actively recruiting in 2026, with 150 U.S. sites across 37 states. See the recruiting trials and the per-state site list further down this page.
What conditions is Inclisiran being studied for?: Inclisiran is being studied for Atherosclerotic Cardiovascular Disease, Hypercholesterolemia, Elevated Cholesterol, Acute Coronary Syndrome, ASCVD and 38 more. The trials are grouped by indication on this page.
What phase is Inclisiran in?: Inclisiran clinical trials span 11 Phase 4, 24 Phase 3, 3 Phase 2, 2 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
Who sponsors Inclisiran clinical trials?: The lead sponsor across the most Inclisiran trials is Novartis Pharmaceuticals, with 14 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.

Sources and methodology

Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Inclisiranas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.

Last refreshed June 18, 2026.

Related pages on Hipa.ai:

Inclisiran overview Inclisiran evidence & publications