Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate the safety, pharmacokinetics, and therapeutic utility of bempedoic acid for cardiovascular and lipid disorders, including hypercholesterolemia, hyperlipidemia, atherosclerotic cardiovascular disease, and acute coronary syndromes. Sponsored by academic investigators and commercial leaders such as Esperion Therapeutics, Novartis, Daiichi Sankyo, and Otsuka Pharmaceutical, these completed, active, and recruiting studies also include Phase 2 protocols in pediatric hypercholesterolemia and HIV-associated dyslipidemia. Additionally, observational and post-marketing studies continue to monitor real-world safety and treatment outcomes.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07282821 NOT_YET_RECRUITING
ADPKD (Autosomal Dominant Polycystic Kidney Disease)
Kenneth Hallows
 2026-09-21 PHASE2
NCT07474649 NOT_YET_RECRUITING
Coronary Atherosclerosis; Mixed Dyslipidemia; Hypercholesterolemia
Daiichi Sankyo
 2026-08-15 PHASE3
NCT05488431 RECRUITING
Dyslipidemias; Cardiovascular Diseases; HIV Infections; Atherosclerosis
Priscilla Hsue, MD
 2023-03-01 PHASE2
NCT07440381 NOT_YET_RECRUITING
Acute Coronary Syndromes; Secondary Prevention; Lipids
Heart Care Foundation
 2026-09 PHASE3
NCT07623915 NOT_YET_RECRUITING
Primary Hyperlipidemia
CSPC Ouyi Pharmaceutical Co., Ltd.
 2026-06-12 PHASE3
NCT07614958 RECRUITING
Mixed Dyslipidemia; Hypercholesterolaemia
A. Menarini International Licensing S.A.
 2026-05-06 PHASE3
NCT07239414 NOT_YET_RECRUITING
Cardiovascular
Sohaib Ashraf
 2025-11-10 PHASE3
NCT07508254 NOT_YET_RECRUITING
Acute Coronary Syndromes (ACS); Hypercholesterolemia
Punjab Institute of Cardology
 2026-05-01 PHASE4
NCT05587621 NOT_YET_RECRUITING
ST Elevation Myocardial Infarction; Non-ST Elevation Myocardial Infarction; LDL-cholesterol
Jena University Hospital
 2024-04-01
NCT07255820 COMPLETED
Type 2 Diabetes Mellitus; Hypercholesterolemia / Elevated LDL Cholesterol
Bahria University
 2026-01-01 PHASE4
NCT07268625 COMPLETED
Healthy Subjects
Daiichi Sankyo
 2025-12-09 PHASE1
NCT07235189 COMPLETED
Healthy Subjects
Daiichi Sankyo
 2025-10-28 PHASE1
NCT07201545 COMPLETED
Healthy Subjects
Daiichi Sankyo
 2025-10-07 PHASE1
NCT06431763 COMPLETED
Hypercholesterolemia
Novartis Pharmaceuticals
 2024-06-21 PHASE4
NCT07182383 COMPLETED
Healthy Subjects
Daiichi Sankyo
 2025-09-29 PHASE1
NCT06742853 COMPLETED
Dyslipidemia
AstraZeneca
 2024-12-20 PHASE1
NCT06925100 COMPLETED
Primary Hypercholesterolemia or Mixed Hyperlipidemia
Daiichi Sankyo
 2025-04-01 PHASE4
NCT06780410 RECRUITING
Primary Hyperlipidemia
Gan & Lee Pharmaceuticals.
 2024-12-20 PHASE3
NCT06381947 UNKNOWN
Dyslipidemias; Statin Adverse Reaction; Cardiovascular Diseases; Lipid Metabolism Disorders
University of Salerno
 2024-05-01 PHASE4
NCT07170852 COMPLETED
Hypercholesterolaemia
Humanis Saglık Anonim Sirketi
 2025-05-21 PHASE1
NCT05694260 COMPLETED
Hypercholesterolemia
Esperion Therapeutics, Inc.
 2023-01-12 PHASE2
NCT06450366 COMPLETED
Hypercholesterolemia
Merck Sharp & Dohme LLC
 2024-07-08 PHASE3
NCT06923956 COMPLETED
Hypercholesterolaemia; Mixed Dyslipidaemia; Cardiovascular Diseases
Humanis Saglık Anonim Sirketi
 2024-12-04 PHASE1
NCT06035874 RECRUITING
Type 2 Diabetes; Non Alcholic Fatty Liver Disease
Medanta, The Medicity, India
 2023-10-15
NCT05687071 COMPLETED
Hyper-low-density Lipoprotein (LDL) Cholesterolemia
Otsuka Pharmaceutical Co., Ltd.
 2023-02-27 PHASE3
NCT06021951 COMPLETED
Healthy Lactating Women
Esperion Therapeutics, Inc.
 2023-08-04 PHASE4
NCT05683340 COMPLETED
Hyper-low-density Lipoprotein (LDL) Cholesterolemia
Otsuka Pharmaceutical Co., Ltd.
 2023-02-13 PHASE3
NCT05263778 UNKNOWN
Cardiovascular Diseases; NSTEMI; STEMI
Kaiser Permanente
 2022-03 PHASE4
NCT05694260 Recruiting
Hypercholesterolemia
Esperion Therapeutics Inc.
 2023-01-12 Phase 2
NCT02993406 COMPLETED
Cardiovascular Diseases; Statin Adverse Reaction
Esperion Therapeutics, Inc.
 2016-12-22 PHASE3
NCT04784442 COMPLETED
Hypercholesterolemia
Otsuka Pharmaceutical Co., Ltd.
 2021-03-24 PHASE2
NCT04929249 Completed
Atherosclerotic Cardiovascular Disease
Novartis Pharmaceuticals|Novartis
 2021-06-25 Phase 3
NCT03067441 COMPLETED
Hypercholesterolemia; Atherosclerotic Cardiovascular Disease
Esperion Therapeutics, Inc.
 2017-02-03 PHASE3
NCT03531905 COMPLETED
Diabetes; Diabetes Mellitus, Type 2; Cholesterolemia
Esperion Therapeutics, Inc.
 2018-05-09 PHASE2
NCT02991118 COMPLETED
Hypercholesterolemia; Atherosclerotic Cardiovascular Disease
Esperion Therapeutics, Inc.
 2016-11-18 PHASE3
NCT03337308 COMPLETED
Hyperlipidemias
Esperion Therapeutics, Inc.
 2017-10-23 PHASE3
NCT02988115 COMPLETED
Hypercholesterolemia; Atherosclerotic Cardiovascular Disease; Statin Adverse Reaction
Esperion Therapeutics, Inc.
 2016-11-16 PHASE3
NCT02666664 COMPLETED
Hypercholesterolemia; Atherosclerotic Cardiovascular Diseases
Esperion Therapeutics, Inc.
 2016-01-21 PHASE3
NCT03193047 COMPLETED
Hypercholesterolemia
Esperion Therapeutics, Inc.
 2017-04-07 PHASE2
NCT03001076 COMPLETED
Hypercholesterolemia; Atherosclerosis; Statin Adverse Reaction
Esperion Therapeutics, Inc.
 2016-11-29 PHASE3
NCT03051100 COMPLETED
Hypercholesterolemia
Esperion Therapeutics, Inc.
 2017-01-19 PHASE2
NCT02659397 COMPLETED
Hyperlipidemia
Esperion Therapeutics, Inc.
 2015-12 PHASE2
NCT02659397 Completed
Hyperlipidemia
Esperion Therapeutics Inc.
 2015-12 Phase 2
NCT02178098 COMPLETED
Hypercholesterolemia; Hypertension
Esperion Therapeutics, Inc.
 2014-06-16 PHASE2
NCT02072161 COMPLETED
Hypercholesterolemia
Esperion Therapeutics, Inc.
 2014-03 PHASE2
NCT01941836 COMPLETED
Hypercholesterolemia
Esperion Therapeutics, Inc.
 2013-09 PHASE2
NCT02178098 Completed
Hypercholesterolemia|Hypertension
Esperion Therapeutics Inc.|Medpace Inc.
 2014-06-16 Phase 2
NCT02044627 COMPLETED
Hyperlipidemia
Esperion Therapeutics, Inc.
 2013-12 PHASE1
NCT01779453 COMPLETED
Hypercholesterolemia
Esperion Therapeutics, Inc.
 2012-12 PHASE2
NCT01751984 COMPLETED
Hypercholesterolemia
Esperion Therapeutics, Inc.
 2012-10-04 PHASE2
NCT01607294 COMPLETED
Hyperlipidemia; Type 2 Diabetes
Esperion Therapeutics, Inc.
 2012-04 PHASE2
NCT01485146 COMPLETED
Safety Evaluation of Escalating Doses
Esperion Therapeutics, Inc.
 2011-10-25 PHASE1
NCT01262638 COMPLETED
Dyslipidemia
Esperion Therapeutics, Inc.
 2010-12 PHASE2
NCT01105598 COMPLETED
Mild Dyslipidemia
Esperion Therapeutics, Inc.
 2010-04-20 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-23)

Check the Bempedoic acid (ETC-1002) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bempedoic acid inhibits hepatic ATP-citrate lyase and activates AMP-activated protein kinase, thereby suppressing downstream de novo cholesterol synthesis and upregulating hepatic low-density lipoprotein receptor expression. This cellular response enhances systemic clearance of circulating low-density lipoprotein cholesterol, directly mitigating hypercholesterolemia and atherosclerotic cardiovascular disease as evaluated in clinical trials.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.