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Showing 1–24 of 33 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: ALN-PCSSC Clear all
Completed Phase 3 Interventional Results available

Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia

NCT04659863
View directory record Official record
Conditions
Familial Hypercholesterolemia - Homozygous
Interventions
Inclisiran, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
12 Years to 17 Years
Enrollment
13 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
1
States / cities
Boca Raton, Florida
Source: ClinicalTrials.gov public record
Updated Jan 12, 2026 · Synced Sep 6, 2026, 8:14 AM EDT
Completed No phase listed Observational

Patterns of Inclisiran Use in the Real World: An Analysis of US Databases

NCT07023445
View directory record Official record
Conditions
Atherosclerotic Cardiovascular Disease, Familial Hypercholesterolemia
Interventions
Not listed
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
37,688 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
1
States / cities
East Hanover, New Jersey
Source: ClinicalTrials.gov public record
Updated Jun 16, 2025 · Synced Sep 6, 2026, 8:14 AM EDT
Completed Phase 2 Interventional Results available

Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low Density Lipoprotein Cholesterol (LDL-C)

NCT02597127
View directory record Official record
Conditions
Atherosclerotic Cardiovascular Disease, Familial Hypercholesterolemia, Diabetes
Interventions
ALN-PCSSC, Normal Saline
Drug
Lead sponsor
The Medicines Company
Industry
Eligibility
18 Years to 99 Years
Enrollment
501 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
8
States / cities
Jacksonville, Florida • Indianapolis, Indiana • New York, New York + 4 more
Source: ClinicalTrials.gov public record
Updated May 16, 2019 · Synced Sep 6, 2026, 8:14 AM EDT
Active, not recruiting Phase 3 Interventional

A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.

NCT05739383
View directory record Official record
Conditions
Primary Prevention of Atherosclerotic Cardiovascular Disease
Interventions
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL, Placebo in 1.5ml
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
40 Years to 79 Years
Enrollment
14,012 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2029
U.S. locations
242
States / cities
Birmingham, Alabama • Fairhope, Alabama • Foley, Alabama + 188 more
Source: ClinicalTrials.gov public record
Updated Sep 3, 2026 · Synced Sep 6, 2026, 8:14 AM EDT
Completed No phase listed Observational

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

NCT07615166
View directory record Official record
Conditions
Atherosclerotic Cardiovascular Disease
Interventions
Alirocumab 150 mg, Inclisiran
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
996 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
1
States / cities
Bridgewater, New Jersey
Source: ClinicalTrials.gov public record
Updated Sep 3, 2026 · Synced Sep 6, 2026, 8:14 AM EDT
Recruiting Phase 3 Interventional

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

NCT05682378
View directory record Official record
Conditions
Heterozygous or Homozygous Familial Hypercholesterolemia
Interventions
Inclisiran
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
12 Years to 100 Years
Enrollment
195 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2032
U.S. locations
5
States / cities
Boca Raton, Florida • New York, New York • Cincinnati, Ohio + 2 more
Source: ClinicalTrials.gov public record
Updated May 14, 2026 · Synced Sep 6, 2026, 8:14 AM EDT
Completed No phase listed Observational

A Real-world Study of Inclisiran Adherence, Treatment Patterns, Patient Characteristics, and Effectiveness in ASCVD Patients With Hypercholesterolemia, ASCVD-risk Equivalent Patients With Hypercholesterolemia and Familial Hypercholesterolemia

NCT06507852
View directory record Official record
Conditions
Atherosclerotic Cardiovascular Disease, Hypercholesterolemia
Interventions
Not listed
Lead sponsor
Novartis
Industry
Eligibility
18 Years and older
Enrollment
95 participants
Timeline
2022 – 2023
U.S. locations
1
States / cities
East Hanover, New Jersey
Source: ClinicalTrials.gov public record
Updated Jul 17, 2024 · Synced Sep 6, 2026, 8:14 AM EDT
Completed No phase listed Observational

A Study to Assess the Real-World Effectiveness of Inclisiran and PCSK9 mAbs in Chinese Hypercholesterolemia Adult Patients

NCT07409636
View directory record Official record
Conditions
Hypercholesterolemia, Mixed Dyslipidemia
Interventions
Not listed
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
11,991 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025
U.S. locations
1
States / cities
East Hanover, New Jersey
Source: ClinicalTrials.gov public record
Updated Feb 16, 2026 · Synced Sep 6, 2026, 8:14 AM EDT
Completed Phase 3 Interventional Results available

Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.

NCT05763875
View directory record Official record
Conditions
Hypercholesterolemia
Interventions
Inclisiran, Ezetimibe, Matching Placebo for Inclisiran, Matching Placebo for Ezetimibe
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 75 Years
Enrollment
350 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
22
States / cities
Birmingham, Alabama • Dothan, Alabama • DeLand, Florida + 19 more
Source: ClinicalTrials.gov public record
Updated Oct 15, 2025 · Synced Sep 6, 2026, 8:14 AM EDT
Recruiting Phase 3 Interventional

Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia

NCT06597019
View directory record Official record
Conditions
Familial Hypercholesterolemia - Heterozygous
Interventions
Inclisiran, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
6 Years to 11 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
9
States / cities
San Francisco, California • Washington D.C., District of Columbia • Boca Raton, Florida + 4 more
Source: ClinicalTrials.gov public record
Updated May 14, 2026 · Synced Sep 6, 2026, 8:14 AM EDT
Completed No phase listed Observational

Potential Eligibility and Estimated Preventable Cardiovascular Disease Events From Inclisiran Treatment in the United States

NCT07214857
View directory record Official record
Conditions
Cardiovascular Disease
Interventions
Not listed
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
1,385 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024
U.S. locations
1
States / cities
East Hanover, New Jersey
Source: ClinicalTrials.gov public record
Updated Oct 8, 2025 · Synced Sep 6, 2026, 8:14 AM EDT
Recruiting Phase 2 Interventional

A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia

NCT07610278
View directory record Official record
Conditions
Hypercholesterolaemia
Interventions
QCZ484, Inclisiran, QCZ484 placebo, Inclisiran placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 75 Years
Enrollment
120 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
27
States / cities
Foley, Alabama • Saraland, Alabama • Lincoln, California + 24 more
Source: ClinicalTrials.gov public record
Updated Jul 29, 2026 · Synced Sep 6, 2026, 8:14 AM EDT
Recruiting Phase 1 Interventional Accepts healthy volunteers

Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation

NCT07626281
View directory record Official record
Conditions
Inclisiran Formulation
Interventions
Inclisiran formulation containing PS80, Currently marketed inclisiran formulation
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 60 Years
Enrollment
120 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026
U.S. locations
3
States / cities
Lenexa, Kansas • San Antonio, Texas • Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Jul 9, 2026 · Synced Sep 6, 2026, 8:14 AM EDT
Completed Phase 2 Interventional Results available

An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol

NCT03060577
View directory record Official record
Conditions
Atherosclerotic Cardiovascular Disease, Symptomatic Atherosclerosis, Type2 Diabetes, Familial Hypercholesterolemia
Interventions
Inclisiran, Evolocumab
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
382 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2021
U.S. locations
8
States / cities
Jacksonville, Florida • Indianapolis, Indiana • New York, New York + 4 more
Source: ClinicalTrials.gov public record
Updated Mar 23, 2023 · Synced Sep 6, 2026, 8:14 AM EDT
Active, not recruiting Phase 3 Interventional

A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease

NCT03705234
View directory record Official record
Conditions
Atherosclerotic Cardiovascular Disease
Interventions
Inclisiran, Placebo
Drug
Lead sponsor
University of Oxford
Other
Eligibility
40 Years and older
Enrollment
16,124 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2049
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Apr 30, 2026 · Synced Sep 6, 2026, 8:14 AM EDT
Active, not recruiting Phase 4 Interventional

VictORION-INCLUSION: Evaluating Inclisiran for Cholesterol Managment in Heart Disease

NCT06249165
View directory record Official record
Conditions
Atherosclerotic Cardiovascular Disease
Interventions
Inclisiran
Drug
Lead sponsor
Duke University
Other
Eligibility
18 Years and older
Enrollment
130 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
23
States / cities
Birmingham, Alabama • Orange, California • San Francisco, California + 20 more
Source: ClinicalTrials.gov public record
Updated Jul 28, 2026 · Synced Sep 6, 2026, 8:14 AM EDT
Recruiting Phase 3 Interventional

Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia

NCT06597006
View directory record Official record
Conditions
Familial Hypercholesterolemia - Homozygous
Interventions
Inclisiran, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
2 Years to 11 Years
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
4
States / cities
San Francisco, California • Washington D.C., District of Columbia • St Louis, Missouri + 1 more
Source: ClinicalTrials.gov public record
Updated Jul 23, 2026 · Synced Sep 6, 2026, 8:14 AM EDT
Withdrawn Phase 4 Interventional

Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP)

NCT06280976
View directory record Official record
Conditions
Coronary Artery Disease, Atherosclerosis, Heart Attack
Interventions
Statin, Aspirin tablet, Nexlizet, LEQVIO, Vascepa, Jardiance, Colchicine
Drug
Lead sponsor
University of Louisville
Other
Eligibility
18 Years to 80 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2025
U.S. locations
1
States / cities
Louisville, Kentucky
Source: ClinicalTrials.gov public record
Updated Mar 16, 2025 · Synced Sep 6, 2026, 8:14 AM EDT
Completed Phase 3 Interventional Results available

Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia

NCT04652726
View directory record Official record
Conditions
Familial Hypercholesterolemia - Heterozygous
Interventions
Inclisiran, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
12 Years to 17 Years
Enrollment
141 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
6
States / cities
Tucson, Arizona • New York, New York • Winston-Salem, North Carolina + 3 more
Source: ClinicalTrials.gov public record
Updated Jan 12, 2026 · Synced Sep 6, 2026, 8:14 AM EDT
Completed Phase 3 Interventional Results available

Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol

NCT03399370
View directory record Official record
Conditions
ASCVD, Elevated Cholesterol
Interventions
Inclisiran Sodium, Placebo
Drug
Lead sponsor
The Medicines Company
Industry
Eligibility
18 Years and older
Enrollment
1,561 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
145
States / cities
Birmingham, Alabama • Foley, Alabama • Huntsville, Alabama + 110 more
Source: ClinicalTrials.gov public record
Updated Oct 4, 2020 · Synced Sep 6, 2026, 8:14 AM EDT
Recruiting Phase 4 Interventional

Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention

NCT06909565
View directory record Official record
Conditions
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Interventions
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL, Normal Saline (Placebo)
Drug
Lead sponsor
Duke University
Other
Eligibility
18 Years and older
Enrollment
6,000 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
136
States / cities
Alexander City, Alabama • Birmingham, Alabama • Huntsville, Alabama + 122 more
Source: ClinicalTrials.gov public record
Updated Aug 27, 2026 · Synced Sep 6, 2026, 8:14 AM EDT
Completed Phase 2 Interventional Results available

A Study of ALN-PCSSC in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

NCT02963311
View directory record Official record
Conditions
Homozygous Familial Hypercholesterolemia
Interventions
ALN-PCSSC, Standard of Care
Drug
Lead sponsor
The Medicines Company
Industry
Eligibility
12 Years and older
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated May 17, 2020 · Synced Sep 6, 2026, 8:14 AM EDT
Recruiting Phase 3 Interventional

The Prevent Coronary Artery Disease Trial

NCT06494501
View directory record Official record
Conditions
Atherosclerotic Cardiovascular Disease
Interventions
Inclisiran
Drug
Lead sponsor
Icahn School of Medicine at Mount Sinai
Other
Eligibility
30 Years to 50 Years
Enrollment
1,600 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2032
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Apr 28, 2025 · Synced Sep 6, 2026, 8:14 AM EDT
Completed Phase 3 Interventional Results available

Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome

NCT04873934
View directory record Official record
Conditions
Acute Coronary Syndrome
Interventions
Inclisiran
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years
Enrollment
400 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
88
States / cities
Jonesboro, Arkansas • Bakersfield, California • Fresno, California + 75 more
Source: ClinicalTrials.gov public record
Updated Oct 15, 2025 · Synced Sep 6, 2026, 8:14 AM EDT