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Showing 1–19 of 19 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Inclisiran Sodium 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 7, 2026, 6:09 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 7, 2026, 6:09 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 7, 2026, 6:09 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 7, 2026, 6:09 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 7, 2026, 6:09 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 7, 2026, 6:09 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 7, 2026, 6:09 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 7, 2026, 6:09 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 7, 2026, 6:09 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 7, 2026, 6:09 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 7, 2026, 6:09 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 7, 2026, 6:09 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 7, 2026, 6:09 AM EDT
Active, not recruiting Phase 3 Interventional

Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease

NCT05030428
View directory record Official record
Conditions
Atherosclerotic Cardiovascular Disease
Interventions
Inclisiran sodium 300 mg, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
40 Years to 100 Years
Enrollment
17,004 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
271
States / cities
Birmingham, Alabama • Fairhope, Alabama • Foley, Alabama + 214 more
Source: ClinicalTrials.gov public record
Updated Aug 24, 2026 · Synced Sep 7, 2026, 6:09 AM EDT
Completed Phase 3 Interventional Results available

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)

NCT04929249
View directory record Official record
Conditions
Atherosclerotic Cardiovascular Disease
Interventions
Inclisiran
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
450 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
43
States / cities
Little Rock, Arkansas • Los Angeles, California • Greenwich, Connecticut + 32 more
Source: ClinicalTrials.gov public record
Updated May 15, 2025 · Synced Sep 7, 2026, 6:09 AM EDT
Recruiting Phase 4 Interventional

LDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering

NCT06865885
View directory record Official record
Conditions
Drug Interactions, Primary Prevention, Cardiometabolic Syndrome, LDL-Cholersterol Lowering
Interventions
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
Drug
Lead sponsor
University of California, San Diego
Other
Eligibility
18 Years to 85 Years
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
1
States / cities
La Jolla, California
Source: ClinicalTrials.gov public record
Updated Jul 12, 2026 · Synced Sep 7, 2026, 6:09 AM EDT
Completed Phase 3 Interventional Results available

Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH)

NCT03397121
View directory record Official record
Conditions
Heterozygous Familial Hypercholesterolemia, Elevated Cholesterol
Interventions
Inclisiran, Placebo
Drug
Lead sponsor
The Medicines Company
Industry
Eligibility
18 Years and older
Enrollment
482 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
10
States / cities
Mission Viejo, California • Newport Beach, California • Stanford, California + 7 more
Source: ClinicalTrials.gov public record
Updated Oct 27, 2020 · Synced Sep 7, 2026, 6:09 AM EDT
Completed Phase 3 Interventional Results available

Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C

NCT03814187
View directory record Official record
Conditions
ASCVD, Elevated Cholesterol, Heterozygous Familial Hypercholesterolemia, Homozygous Familial Hypercholesterolemia
Interventions
Inclisiran Sodium
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
3,275 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2023
U.S. locations
141
States / cities
Birmingham, Alabama • Foley, Alabama • Huntsville, Alabama + 109 more
Source: ClinicalTrials.gov public record
Updated Mar 5, 2024 · Synced Sep 7, 2026, 6:09 AM EDT
Active, not recruiting Phase 3 Interventional

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

NCT05360446
View directory record Official record
Conditions
Coronary Artery Disease
Interventions
Inclisiran sodium 300 mg, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 80 Years
Enrollment
609 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
27
States / cities
Huntsville, Alabama • Anchorage, Alaska • Beverly Hills, California + 22 more
Source: ClinicalTrials.gov public record
Updated Jul 12, 2026 · Synced Sep 7, 2026, 6:09 AM EDT