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2026 data Public-data reference. official source

Hypercholesterolemia

Open-data reference.

62 US clinical trials · 5 currently recruiting

Active & Recent Trials

RECRUITING 2,000 participants

Causes and Natural History of Dyslipidemias

National Heart, Lung, and Blood Institute (NHLBI)

NCT00353782

RECRUITING NA 806 participants

Church-based Health Intervention to Eliminate Racial Inequalities in Cardiovascular Health

Tulane University

NCT06065098

RECRUITING NA 410 participants

Pharmacogenomic Informed Statin Prescribing

VA Office of Research and Development

NCT06568601

RECRUITING Phase 2 130 participants

Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial

Wake Forest University Health Sciences

NCT06488105

RECRUITING 10 participants

Pharmacokinetics of Butyrate Tablet BKR-017

BioKier

NCT06556745

ACTIVE NOT RECRUITING Phase 3 3,000 participants

Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension

Merck Sharp & Dohme

NCT06492291

ACTIVE NOT RECRUITING NA 816 participants

A Tool to Help Patients With Muscle Symptoms After Taking a Statin Medication.

University of Utah

NCT06423365

ACTIVE NOT RECRUITING 105 participants

Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy

Johns Hopkins University

NCT02694094

COMPLETED NA 13,340 participants

Evaluating the Efficacy of Pediatric Lipid Screening Alerts

Geisinger Clinic

NCT04118348

COMPLETED Phase 3 10,251 participants

Action to Control Cardiovascular Risk in Diabetes (ACCORD)

National Heart, Lung, and Blood Institute (NHLBI)

NCT00000620

COMPLETED Phase 3 2,341 participants

Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)

Sanofi

NCT01507831

COMPLETED Phase 4 2,176 participants

Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo

Regeneron Pharmaceuticals

NCT02957682

COMPLETED Phase 3 1,743 participants

12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe

AstraZeneca

NCT00525824

COMPLETED Phase 3 1,311 participants

Actual Use Trial of Atorvastatin Calcium 10 mg

Pfizer's Upjohn has merged with Mylan to form Viatris

NCT01964326

COMPLETED NA 1,114 participants

Study of a Holistic Health Program for United Methodist Clergy

Duke Clergy Health Initiative

NCT01564719

COMPLETED Phase 4 1,000 participants

Cholesterol and Pharmacogenetic Study

UCSF Benioff Children's Hospital Oakland

NCT00451828

COMPLETED Phase 3 986 participants

Open Label Study of Long Term Safety Evaluation of Alirocumab

Sanofi

NCT01954394

COMPLETED Phase 3 970 participants

GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound

Amgen

NCT01813422

COMPLETED Phase 3 803 participants

Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1)

Regeneron Pharmaceuticals

NCT01926782

COMPLETED 600 participants

A Real-world Study to Assess the Characteristics and Long-term Effectiveness of Inclisiran in Chinese Adult Patients

Novartis

NCT06595069

COMPLETED Phase 1 500 participants

Potential Risk Factors for Stroke

National Institute of Neurological Disorders and Stroke (NINDS)

NCT00001368

COMPLETED Phase 3 424 participants

Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia

Amgen

NCT02739984

COMPLETED Phase 3 415 participants

Efficacy of Lapaquistat Acetate Alone or Combined With Rosuvastatin in Subjects With Hypercholesterolemia

Takeda

NCT00249912

COMPLETED Phase 3 412 participants

Efficacy and Safety of Valsartan and the Combination of Valsartan and Simvastatin

Novartis

NCT00385931

COMPLETED Phase 3 350 participants

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

Novartis Pharmaceuticals

NCT05763875

COMPLETED Phase 2 349 participants

Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients

Esperion Therapeutics

NCT01941836

COMPLETED Phase 3 316 participants

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I)

Sanofi

NCT01644175

COMPLETED Phase 3 303 participants

A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)

Merck Sharp & Dohme

NCT05952869

COMPLETED Phase 3 301 participants

A Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018) CORALreef AddOn

Merck Sharp & Dohme

NCT06450366

COMPLETED 300 participants

Metabolic Abnormalities in HIV Infected and Uninfected Young Women

University of North Carolina, Chapel Hill

NCT00067587

COMPLETED Phase 3 269 participants

Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility)

Esperion Therapeutics

NCT03001076

COMPLETED Phase 4 230 participants

Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression

National Heart, Lung, and Blood Institute (NHLBI)

NCT01212900

COMPLETED Phase 2 150 participants

Study of Oral MD-0727 Administered to Patients With Primary Hypercholesterolemia

Ironwood Pharmaceuticals

NCT00404001

COMPLETED Phase 2 143 participants

Evaluation of ETC-1002 in Participants With Hypercholesterolemia and Hypertension

Esperion Therapeutics

NCT02178098

COMPLETED Phase 4 134 participants

A Study Comparing CoQ10 Levels While Taking 3 Different Statins

University of Kansas Medical Center

NCT01660191

COMPLETED Phase 1 133 participants

A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects

Pfizer

NCT01720537

COMPLETED Phase 4 129 participants

Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol

Daiichi Sankyo

NCT00754039

COMPLETED NA 124 participants

Diets Enriched With Pecans

University of Georgia

NCT04376632

COMPLETED NA 100 participants

The Effect of BiosLife on Serum Lipids

University of Utah

NCT00457756

COMPLETED Phase 2 99 participants

Pilot Study To Assess CAT-2003 in Patients With Hyperlipidemia

Catabasis Pharmaceuticals

NCT01912560

COMPLETED Phase 3 98 participants

Effect of a Decision Aid About Statin Use in Patients With Type 2 Diabetes Mellitus

Mayo Clinic

NCT00217061

COMPLETED 95 participants

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

Novartis

NCT06507852

COMPLETED Phase 1 87 participants

Study of the Response of Human Small Blood Vessels

National Heart, Lung, and Blood Institute (NHLBI)

NCT00001622

COMPLETED Phase 4 76 participants

Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet

Pfizer's Upjohn has merged with Mylan to form Viatris

NCT00917579

COMPLETED Phase 1 74 participants

Safety, Tolerability, PK and PD of LGT209 in Healthy Volunteers and Patients With Hypercholesterolemia

Novartis Pharmaceuticals

NCT01979601

COMPLETED Phase 1 72 participants

Ascending Multi-dose Study of REGN727(SAR236553) With and Without Concomitant Atorvastatin

Regeneron Pharmaceuticals

NCT01161082

COMPLETED Phase 4 72 participants

A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Simvastatin for at Least 4 Weeks.

Daiichi Sankyo

NCT00753779

COMPLETED Phase 1 68 participants

Safety And Tolerability Of Multiple Doses Of PF-04950615 (RN316) In Subjects With Hypercholesterolemia

Pfizer

NCT01243151

COMPLETED Phase 2 63 participants

Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg, Ezetimibe 10mg, and Atorvastatin 20 mg Triplet Therapy in Patients With Elevated LDL-C

Esperion Therapeutics

NCT03051100

COMPLETED Phase 2 60 participants

The Safety & Efficacy of Combination BMS-201038 (AEGR-733) & Ezetimibe vs. Monotherapy in Moderate Hypercholesterolemia

Aegerion Pharmaceuticals

NCT00405067

COMPLETED NA 60 participants

Low Fat Vegan or American Heart Association Diets & Cardiovascular Risk in Obese 9-18 y.o. With Elevated Cholesterol

The Cleveland Clinic

NCT01817491

COMPLETED Phase 2 58 participants

Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)

Regeneron Pharmaceuticals

NCT01576484

COMPLETED NA 57 participants

Effect of Diabetes Mellitus on Cholesterol Metabolism

Medical College of Wisconsin

NCT00879710

COMPLETED Phase 1 43 participants

Pilot Program to Improve Statin Adherence and Lower Cholesterol in Older Adults

University of Missouri-Columbia

NCT01227330

COMPLETED Phase 2 36 participants

Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells

Emory University

NCT00166036

COMPLETED Phase 4 34 participants

Comparison of the Effect of Vytorin 10/80 Tablet Split Into 4 and Simvastatin 20 Milligrams on Low-density Lipoprotein (LDL) Cholesterol

Bronx VA Medical Center

NCT00762164

COMPLETED Phase 2 32 participants

Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003

LIB Therapeutics

NCT03847974

COMPLETED NA 30 participants

Niacin for Treatment of Elevated Cholesterol and Triglycerides in HIV-Infected Patients

National Institute of Allergy and Infectious Diseases (NIAID)

NCT00046267

COMPLETED NA 22 participants

Evaluation of Ubiquinol on Mitochondrial Oxidative Capacity in Statin Patients Using 31PMRS

Beth Israel Deaconess Medical Center

NCT01702987

COMPLETED 19 participants

Using Nudges to Implement Comparative Effectiveness

NYU Langone Health

NCT01575171

COMPLETED Phase 1 13 participants

A Study of LY3015014 in Healthy Participants With High Cholesterol

Eli Lilly and Company

NCT01671085

COMPLETED NA 10 participants

Metabolism And Health Effects Of Citrus Limonoids in Hypercholesterolemic Humans

USDA, Western Human Nutrition Research Center

NCT02011789

Phase Distribution

PhaseTrial count
Early Phase 1 8
Phase 2 10
Phase 3 17
Phase 4 8

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

Reading the Hypercholesterolemia Trial Landscape

ClinicalTrials.gov lists 62 US studies indexed under Hypercholesterolemia, and 5 of those are currently open to recruitment — roughly 8% of the total volume on the registry. That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.

The phase distribution for Hypercholesterolemia shows 25 late-stage studies (Phase 3 and Phase 4 combined) alongside 18 earlier-phase entries (Phase 1 through Phase 2). Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.

Top sponsor activity for Hypercholesterolemia is led by Esperion Therapeutics with 4 indexed trials, alongside 9 other organizations in the top contributor list. The list on this page surfaces up to 62 of the most relevant recent and active entries, ordered with recruiting studies first so practical options are visible. All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation — eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.

Frequently Asked Questions

How many clinical trials are there for Hypercholesterolemia?

PlainTrial tracks 62 US clinical trials for Hypercholesterolemia, of which 5 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Hypercholesterolemia?

Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.

Is this data current?

Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.

Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2024 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.

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