Clinical Trials

Numerous clinical trials evaluate fenofibrate across Phase 1 through Phase 4 studies sponsored by academic institutions, government entities, and pharmaceutical manufacturers, including the Mayo Clinic, the National Institute of Allergy and Infectious Diseases, Abbott, and Sanofi. These evaluations span metabolic, cardiovascular, renal, and infectious indications, such as hypercholesterolemia, hypertriglyceridemia, metabolic syndrome, diabetic nephropathies, post-liver transplantation complications, COVID-19, and HIV. With recruitment statuses ranging from actively recruiting to completed and terminated, representative Phase 2 and Phase 3 protocols examine fenofibrate for preventing ischemic cholangiopathy and treating diabetic nephropathy.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06755151 RECRUITING
Primary Biliary Cholangitis (PBC)
Xijing Hospital of Digestive Diseases
 2024-01-17 PHASE3
NCT06755541 RECRUITING
Primary Biliary Cholangitis (PBC)
Xijing Hospital of Digestive Diseases
 2024-01-30 PHASE3
NCT07104201 ACTIVE_NOT_RECRUITING
Primary Biliary Cholangitis (PBC)
Xijing Hospital of Digestive Diseases
 2025-03-13 EARLY_PHASE1
NCT04661358 ACTIVE_NOT_RECRUITING
Diabetic Retinopathy
Jaeb Center for Health Research
 2021-03-05 PHASE3
NCT07296458 RECRUITING
Primary Biliary Cholangitis (PBC)
Xijing Hospital of Digestive Diseases
 2025-12-15 PHASE3
NCT06905054 RECRUITING
Primary Sclerosing Cholangitis; Liver Transplant, Complications; PSC; Biliary Strictures
Mayo Clinic
 2025-04-15 PHASE2
NCT05749822 RECRUITING
Primary Biliary Cholangitis
Xijing Hospital of Digestive Diseases
 2023-02-17 PHASE2; PHASE3
NCT05751967 RECRUITING
Primary Biliary Cholangitis
Xijing Hospital of Digestive Diseases
 2023-02-22 PHASE3
NCT07774741 NOT_YET_RECRUITING
Jaundice, Neonatal
Rubab Fatima
 2026-10 PHASE4
NCT07572552 NOT_YET_RECRUITING
Sepsis
Tanta University
 2026-05 PHASE2
NCT06365424 RECRUITING
Primary Biliary Cholangitis
Xijing Hospital of Digestive Diseases
 2017-04-08 PHASE2; PHASE3
NCT06293417 RECRUITING
T2DM (Type 2 Diabetes Mellitus); Dyslipidemias
Korea University Anam Hospital
 2024-03-01
NCT05365425 RECRUITING
Dyslipidemia; Atherosclerosis; Diabetes Mellitus, Type 2
Seoul National University Bundang Hospital
 2023-06-01 PHASE4
NCT06191133 RECRUITING
Cervical Intraepithelial Neoplasia; Invasive Cervical Cancer
Lindsay Ferguson, MD
 2024-11-20 PHASE1
NCT06174402 ACTIVE_NOT_RECRUITING
Primary Biliary Cholangitis
Han Ying
 2023-08-21 PHASE2; PHASE3
NCT01320345 ACTIVE_NOT_RECRUITING
Type 1 Diabetes Mellitus; Diabetic Retinopathy; Diabetic Nephropathies
University of Sydney
 2016-11-03 PHASE3
NCT07025005 RECRUITING
Peripheral Neuropathy; Multiple Myeloma, Neoplasms
Tanta University
 2025-08-30 PHASE4
NCT05753267 COMPLETED
Inflammatory Bowel Diseases
Tanta University
 2023-02-28 PHASE2; PHASE3
NCT06591455 COMPLETED
Primary Biliary Cholangitis (PBC)
Han Ying
 2024-09-14 EARLY_PHASE1
NCT05498090 UNKNOWN
Klinefelter Syndrome
University of Colorado, Denver
 2022-11-03 PHASE4
NCT06623539 ACTIVE_NOT_RECRUITING
Non Alcoholic Fatty Liver Disease
Yokohama City University
 2020-12-23 PHASE2
NCT04929379 ACTIVE_NOT_RECRUITING
Diabetic Nephropathies
Alessandro Doria
 2022-01-04 PHASE2
NCT06155331 COMPLETED
Breast Cancer Stage 2 and 3
Tanta University
 2023-12-01 PHASE2
NCT05542147 COMPLETED
Type 2 Diabetes; Cardiovascular Diseases; Pharmacogenomic Drug Interaction
Mario Luca Morieri
 2022-07-03
NCT05781698 COMPLETED
Inflammatory Bowel Diseases
Tanta University
 2023-03-20 PHASE2
NCT05813145 COMPLETED
Breast Cancer
Damanhour University
 2023-01-01
NCT06346743 UNKNOWN
Physiological Neonatal Jaundice; Physiological Hyperbilirubinaemia
Muhammad Zark
 2024-04 PHASE2; PHASE3
NCT05514119 TERMINATED
Liver Transplant
Mayo Clinic
 2022-08-17 PHASE2
NCT04907084 ACTIVE_NOT_RECRUITING
Macular Telangiectasia Type 2
The Lowy Medical Research Institute Limited
 2022-04-07 PHASE2
NCT02823366 UNKNOWN
Primary Biliary Cirrhosis
Xijing Hospital of Digestive Diseases
 2016-01 PHASE3
NCT06451900 COMPLETED
Neonatal Jaundice
Ain Shams University
 2023-07-01 PHASE4
NCT03439345 COMPLETED
Diabetic Retinopathy
University of Oxford
 2018-07-23 PHASE4
NCT04998981 COMPLETED
Hyperlipidemia
Kowa Company, Ltd.
 2021-09-17 PHASE3
NCT05514119 Recruiting
Liver Transplant
Mayo Clinic
 2022-08-17 Phase 2
NCT02823353 COMPLETED
Primary Biliary Cirrhosis
Xijing Hospital of Digestive Diseases
 2016-04-08 PHASE3
NCT04661930 UNKNOWN
Corona Virus Disease (COVID-19); Respiratory Distress Syndrome; SARS-CoV-2 Infection
Yaakov Nahmias
 2021-01-01 PHASE3
NCT04882293 UNKNOWN
Dyslipidemia Associated With Type II Diabetes Mellitus
Laboratorios Silanes S.A. de C.V.
 2022-02-15 PHASE3
NCT05256758 UNKNOWN
Aortic Valve Stenosis
University of Oxford
 2019-05-29
NCT04517396 COMPLETED
Covid19
University of Pennsylvania
 2020-08-18 PHASE2
NCT04868019 UNKNOWN
Hyperbilirubinemia, Neonatal
Shaheed Zulfiqar Ali Bhutto Medical University
 2021-09
NCT04528212 COMPLETED
Diabetes Mellitus, Type 2
Rehab Werida
 2020-11-01 PHASE4
NCT02965911 WITHDRAWN
Primary Biliary Cirrhosis
Beijing 302 Hospital
 2016-01 PHASE1; PHASE2
NCT03515213 COMPLETED
Huntington Disease
University of California, Irvine
 2017-04-27 PHASE2
NCT03869931 UNKNOWN
Diabetes Mellitus; Diabetic Nephropathies
Singapore General Hospital
 2019-03-08 PHASE3
NCT03510884 COMPLETED
Hypercholesterolaemia
Sanofi
 2018-05-31 PHASE3
NCT02232360 UNKNOWN
Coronary Artery Disease
Gachon University Gil Medical Center
 2014-01 PHASE4
NCT04650152 Completed
Hypertriglyceridemia|Metabolic Syndrome
Abbott
 2020-10-27 --
NCT04140201 UNKNOWN
Diabetic Retinopathy
Alaa Hassan ElBaz
 2020-02 PHASE4
NCT03557983 UNKNOWN
Radiodermatitis
Second Affiliated Hospital of Soochow University
 2018-06-13
NCT03829514 COMPLETED
Diabetes Mellitus, Type II
Medical University of South Carolina
 2019-02-04 PHASE4
NCT03510715 COMPLETED
Hypercholesterolemia
Sanofi
 2018-08-31 PHASE3
NCT03874260 UNKNOWN
Dyslipidemias
Daewon Pharmaceutical Co., Ltd.
 2018-07-25 PHASE4
NCT01927315 COMPLETED
Diabetes; Diabetic Retinopathy
University of Padova
 2013-08 PHASE4
NCT03011450 COMPLETED
Severe Hypertriglyceridemia
Kowa Research Institute, Inc.
 2016-11-26 PHASE3
NCT03001817 COMPLETED
Severe Hypertriglyceridemia
Kowa Research Institute, Inc.
 2016-11-28 PHASE3
NCT02891408 COMPLETED
Nonalcoholic Steatohepatitis (NASH)
Gilead Sciences
 2016-09-23 PHASE1
NCT03869931 Unknown status
Diabetes Mellitus|Diabetic Nephropathies
Singapore General Hospital|National Medical Research Council (NMRC) Singapore
 2019-03-08 Phase 3
NCT04418180 COMPLETED
Neonatal Jaundice
Mansoura University
 2016-06-01
NCT02452255 TERMINATED
Burn
The University of Texas Medical Branch, Galveston
 2015-11 PHASE2; PHASE3
NCT02890992 COMPLETED
Hypercholesterolaemia
Sanofi
 2016-09-15 PHASE2
NCT02455336 COMPLETED
Spinal Cord Injury; Dyslipidemia
VA Office of Research and Development
 2015-05-18 PHASE2; PHASE3
NCT02984982 COMPLETED
Hypercholesterolemia; Acute Coronary Syndrome
Sanofi
 2016-11-15 PHASE4
NCT03557983 Unknown status
Radiodermatitis
Second Affiliated Hospital of Soochow University
 2018-06-13 Not Applicable
NCT01752842 COMPLETED
Type II Diabetes Mellitus; Diabetes Complications
Washington University School of Medicine
 2013-03
NCT03618797 COMPLETED
Complex-dyslipidemia
Hanlim Pharm. Co., Ltd.
 2015-11 PHASE3
NCT02166593 COMPLETED
Combined Dyslipidemia
Yooyoung Pharmaceutical Co., Ltd.
 2014-05 PHASE3
NCT04885153 COMPLETED
Diabetic Retinopathy; Dyslipidemias; Diabetes Mellitus
Indonesia University
 2016-11-01
NCT03346187 COMPLETED
Dyslipidemias
Chong Kun Dang Pharmaceutical
 2017-05-19 PHASE1
NCT02642159 COMPLETED
Dyslipidemia
Sanofi
 2016-03-15 PHASE4
NCT02314533 UNKNOWN
Microalbuminuria
Beijing Chao Yang Hospital
 2014-12 PHASE4
NCT02262143 COMPLETED
Mixed Dyslipidemias
IlDong Pharmaceutical Co Ltd
 2014-11 PHASE3
NCT02015988 UNKNOWN
Acute Coronary Syndrome; Diabetes Mellitus, Type 2; Hypertriglyceridemia
Koval' O., MD
 2014-01 PHASE4
NCT01956201 UNKNOWN
Mixed Hyperlipidemia
Chong Kun Dang Pharmaceutical
 2013-12 PHASE3
NCT02354976 COMPLETED
Non-alcoholic Fatty Liver Disease (NAFLD; Hypertriglyceridemia
AstraZeneca
 2015-09-01 PHASE2
NCT02158273 COMPLETED
Alcoholism
The Scripps Research Institute
 2014-05 PHASE2
NCT01965834 TERMINATED
Multiple Myeloma
University of Miami
 2012-11-19 PHASE2
NCT01574131 TERMINATED
Second or Third Degree Burns
The University of Texas Medical Branch, Galveston
 2012-05 PHASE4
NCT02886299 COMPLETED
Fenofibrate/Simvastatin Comparison
Cairo University
 2013-10 PHASE4
NCT00923676 UNKNOWN
Sexual Dysfunction; Hyperlipidemia
University of Campania Luigi Vanvitelli
 2008-04 PHASE4
NCT03615534 COMPLETED
Atherogenic Dyslipidemia; Obesity Associated Disorder
Lewai Sharki Abdulaziz, MSc PhD
 2014-10-01 PHASE4
NCT00884819 TERMINATED
Polycystic Ovary Syndrome
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
 2008-12
NCT02250976 COMPLETED
Healthy Male Volunteers
Hanlim Pharm. Co., Ltd.
 2014-09 PHASE1
NCT02066207 COMPLETED
Dyslipidemia (Fredrickson Type Ⅱa); Dyslipidemia (Fredrickson Type Ⅱb)
Chong Kun Dang Pharmaceutical
 2014-03-18 PHASE1
NCT01462877 COMPLETED
Dyslipidemias; Cardiovascular Diseases; Hypertriglyceridemia
Abbott
 2011-10 PHASE4
NCT01426438 COMPLETED
HIV-1 Infection
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2011-11 PHASE2
NCT01674712 COMPLETED
Dyslipidemia
Abbott
 2012-06 PHASE3
NCT01289639 TERMINATED
Fatty Liver
VA Office of Research and Development
 2005-10
NCT01148004 COMPLETED
HIV; Fenofibrate; Protease Inhibitors; Hypertriglyceridemia; Glucuronosyltransferase
National Institutes of Health Clinical Center (CC)
 2010-05-13 PHASE1
NCT01723735 COMPLETED
Hypercholesterolemia
Sanofi
 2012-11 PHASE1
NCT01594983 COMPLETED
Non Familial Chylocmicronemia Syndrome (Non-FCS)
Novartis Pharmaceuticals
 2012-06 PHASE2
NCT01767610 COMPLETED
Healthy Male Volunteers
Hanlim Pharm. Co., Ltd.
 2013-01 PHASE1
NCT00357500 COMPLETED
Central Nervous System Tumor, Pediatric; Leukemia; Lymphoma; Neuroblastoma; Sarcoma; Unspecified Childhood Solid Tumor, Protocol Specific
Dana-Farber Cancer Institute
 2005-01 PHASE2
NCT01666041 COMPLETED
Hypertriglyceridemia
Gachon University Gil Medical Center
 2012-01 PHASE4
NCT01280604 COMPLETED
Hyperlipidemias
Kaiser Permanente
 2010-10
NCT00732485 WITHDRAWN
Burn
The University of Texas Medical Branch, Galveston
 2008-08 PHASE2; PHASE3
NCT01142323 TERMINATED
Primary Sclerosing Cholangitis
University of Miami
 2010-10 PHASE1; PHASE2
NCT00470262 COMPLETED
Metabolic Syndrome X; Prediabetic State
VA Office of Research and Development
 2007-01
NCT01101204 UNKNOWN
Diabetes; Dyslipidemia; Inflammation; Cytokines
Medical University of Silesia
 2012-07
NCT00616772 COMPLETED
Coronary Artery Disease; Coronary Heart Disease; Dyslipidemia
AbbVie (prior sponsor, Abbott)
 2008-02 PHASE3
NCT01539616 COMPLETED
Hypertriglyceridemia; Dyslipidemia
Zydus Lifesciences Limited
 2011-11 PHASE2
NCT00872599 COMPLETED
Hypertension
Vanderbilt University
 2009-09 PHASE4
NCT02153879 COMPLETED
Type 2 Diabetes Mellitus; Dyslipidemia
Institut Investigacio Sanitaria Pere Virgili
 2009-02 PHASE4
NCT01010516 UNKNOWN
Dyslipidemia
University of Ioannina
 2009-10 PHASE4
NCT00843661 UNKNOWN
HIV; Hyperlipidemia; HIV Infections
Ospedale di Circolo - Fondazione Macchi
 2009-03 PHASE4
NCT01211847 COMPLETED
Hypertriglyceridemia; Dyslipidemia
Essentialis, Inc.
 2010-10 PHASE2
NCT01353404 COMPLETED
Hyperlipidemia
Samyang Biopharmaceuticals Corporation
 2011-06 PHASE1
NCT01878227 COMPLETED
Hyperlipoproteinemia
Zhejiang University
 2010-07 PHASE3
NCT01048502 COMPLETED
Cardiovascular Disease
University of Pennsylvania
 2010-01
NCT01414803 COMPLETED
Hyperlipidemia
Yonsei University
 2009-03 PHASE4
NCT00683176 COMPLETED
Diabetic Macular Edema
Abbott Products
 2008-09 PHASE2
NCT01003847 COMPLETED
Hypertriglyceridemia
Gachon University Gil Medical Center
 2009-11 PHASE4
NCT00252499 TERMINATED
Fatty Liver; Insulin Resistance
US Department of Veterans Affairs
 2005-10
NCT00819910 TERMINATED
Hypertriglyceridemia in Type 4 Hyperlipidemia; Non Diabetic Subjects With Normoglycemia
Ahmad Slim
 2008-09 PHASE4
NCT00794963 TERMINATED
Metabolic Syndrome
Northwell Health
 2008-11
NCT00552747 COMPLETED
Coronary Heart Disease; Hyperlipidemia
National Heart Institute, Mexico
 2007-10 PHASE4
NCT02306889 COMPLETED
Healthy
Ranbaxy Laboratories Limited
 2010-01
NCT01122355 COMPLETED
Hypertriglyceridemia With Low HDL-cholesterol
Yonsei University
 2009-02 PHASE4
NCT00627653 UNKNOWN
Cardiovascular Diseases
National Institute on Aging (NIA)
 2005-10
NCT00542178 COMPLETED
Diabetic Retinopathy
National Heart, Lung, and Blood Institute (NHLBI)
 2003-10 PHASE3
NCT02306902 COMPLETED
Healthy
Ranbaxy Laboratories Limited
 2009-10
NCT00246376 COMPLETED
Cardiovascular Diseases; Heart Diseases; HIV Infections; Hyperlipidemia; Hypertriglyceridemia; Insulin Resistance; Atherosclerosis
Baylor College of Medicine
 2004-01
NCT00809068 COMPLETED
HDL Cholesterol
Keogh Institute for Medical Research
 2005-08 PHASE4
NCT00575042 COMPLETED
Primary Biliary Cirrhosis
University of Florida
 2007-08 PHASE2
NCT00644592 TERMINATED
Healthy
University of Florida
 2008-03
NCT00000620 COMPLETED
Atherosclerosis; Cardiovascular Diseases; Hypercholesterolemia; Hypertension; Diabetes Mellitus, Type 2; Diabetes Mellitus; Coronary Disease
National Heart, Lung, and Blood Institute (NHLBI)
 1999-09 PHASE3
NCT01099176 COMPLETED
Hyperlipidemia; Impaired Fasting Glycemia
Medical University of Silesia
 2008-05
NCT00673881 COMPLETED
Dyslipidemia
Radiant Research
 2008-03 PHASE1; PHASE2
NCT00491400 TERMINATED
Diabetes Mellitus; Metabolic Syndrome
Boston University
 2005-09
NCT00262964 COMPLETED
Non-alcoholic Fatty Liver Disease
Washington University School of Medicine
 2004-10
NCT00559962 COMPLETED
Hyperlipidemia
Aegerion Pharmaceuticals, Inc.
 2007-10 PHASE2
NCT00186537 COMPLETED
Insulin Resistance; Hypertriglyceridemia
Stanford University
 2003-09
NCT00362206 COMPLETED
Hyperlipidemia
Solvay Pharmaceuticals
 2006-09 PHASE3
NCT00349375 COMPLETED
Hyperlipidemia
Solvay Pharmaceuticals
 2005-11 PHASE3
NCT00362934 COMPLETED
Hyperlipidemia
Solvay Pharmaceuticals
 2006-10 PHASE3
NCT00362323 COMPLETED
Dyslipidemia/Glucose Metabolism Disorder
Solvay Pharmaceuticals
 2006-10 PHASE3
NCT00352183 COMPLETED
Cardiovascular Diseases
Solvay Pharmaceuticals
 2006-01 PHASE3
NCT01109758 COMPLETED
Healthy
Solvay Pharmaceuticals
 2008-03 PHASE1
NCT00891293 COMPLETED
Hypertriglyceridemia
GlaxoSmithKline
 2006-03 PHASE4
NCT00459745 COMPLETED
Combined Hyperlipidemia
Shionogi
 2007-04 PHASE3
NCT00504829 COMPLETED
Dyslipidemia
Veloxis Pharmaceuticals
 2007-07 PHASE2
NCT00816829 TERMINATED
Dyslipidemia; Sleep Apnea Syndrome; Overweight; Obesity
Solvay Pharmaceuticals
 2005-09 PHASE2
NCT00400231 COMPLETED
Metabolic Syndrome x
University of Pennsylvania
 2005-08 PHASE2
NCT00361868 TERMINATED
Dyslipidemia; Glucose Metabolism Disorder
Solvay Pharmaceuticals
 2006-06 PHASE3
NCT00960687 COMPLETED
Healthy
Mutual Pharmaceutical Company, Inc.
 2007-10 PHASE1
NCT00961116 COMPLETED
Healthy
Mutual Pharmaceutical Company, Inc.
 2007-10 PHASE1
NCT00359281 COMPLETED
Healthy
Aegerion Pharmaceuticals, Inc.
 2006-03 PHASE2
NCT00458055 COMPLETED
Coronary Arteriosclerosis; Hypoalphalipoproteinemias; Genetic Diseases, Inborn
McGill University Health Centre/Research Institute of the McGill University Health Centre
 2006-11
NCT00385658 COMPLETED
Dyslipidemia
Novartis
 2006-08 PHASE4
NCT00246636 COMPLETED
Hypertriglyceridemia
GlaxoSmithKline
 2005-10 PHASE4
NCT00813527 COMPLETED
Hyperlipidemias
Takeda
 2006-02 PHASE2
NCT00145431 TERMINATED
Hyperlipoproteinemia Type III
Pfizer
 2005-03 PHASE3
NCT00158899 COMPLETED
Dyslipidaemias; Dyslipidaemia
GlaxoSmithKline
 2004-08 PHASE2
NCT00093899 COMPLETED
Hyperlipidemia; Hypercholesterolemia; Hypertriglyceridemia
Organon and Co
 2004-11 PHASE3
NCT00169559 COMPLETED
Dyslipidaemias
GlaxoSmithKline
 2003-11 PHASE2
NCT00092573 COMPLETED
Hypercholesterolemia; Hypertriglyceridemia
Organon and Co
 2003-04 PHASE3
NCT00703482 COMPLETED
Patients With Type 2 Diabetes
Solvay Pharmaceuticals
 2003-05 PHASE2
NCT00703755 COMPLETED
Patients With Metabolic Syndrome
Solvay Pharmaceuticals
 2003-03 PHASE2
NCT00092560 COMPLETED
Hypercholesterolemia; Hypertriglyceridemia
Organon and Co
 2002-12 PHASE3
NCT00703690 TERMINATED
Metabolic X Syndrome Dyslipidemia
Merck Sharp & Dohme LLC
 2002-01 PHASE2
NCT00754039 COMPLETED
Hypercholesterolemia; Hyperlipidemia, Familial Combined
Daiichi Sankyo
 2003-02 PHASE4
NCT00928694 COMPLETED
Dyslipidemia
Merck Sharp & Dohme LLC
 2003-02 PHASE1
NCT00092157 COMPLETED
Hypercholesterolemia
Organon and Co
 2002-05-01 PHASE3
NCT00775827 COMPLETED
Healthy
Ranbaxy Laboratories Limited
 2002-11
NCT00632840 COMPLETED
Obesity; Lipid Disorders; Hypertriglyceridemia; Cardiovascular Disease
The University of Western Australia
 2001-06 PHASE4
NCT00775359 COMPLETED
Healthy
Ranbaxy Laboratories Limited
 2002-08
NCT00422396 COMPLETED
Hypertriglyceridemia With the Metabolic Syndrome
University of Michigan
 2001-01
NCT00490178 COMPLETED
Diabetes Mellitus, Type 2; Dyslipidemia
Solvay Pharmaceuticals
 2007-03 PHASE3
NCT00076518 COMPLETED
HIV Infections; Hypertriglyceridemia
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00349635 COMPLETED
Obesity
Solvay Pharmaceuticals
 2004-10 PHASE2
NCT00543647 COMPLETED
Healthy Volunteers
Solvay Pharmaceuticals
 2002-08 PHASE1
NCT00361751 COMPLETED
Burns; Insulin Resistance
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2003-05 PHASE2
NCT00304993 COMPLETED
Metabolic Syndrome X; Insulin Resistance
Foundation Research, Florida
 2001-01 PHASE4
NCT00309712 COMPLETED
Type II Diabetes Mellitus; Mixed Dyslipidemia
Intermountain Health Care, Inc.
 2002-08
NCT00139061 COMPLETED
Hyperlipidemia
Pfizer
 2005-03 PHASE3
NCT00362765 TERMINATED
Type 2 Diabetes; Dyslipidemia
Solvay Pharmaceuticals
 2006-10 PHASE2; PHASE3
NCT00349284 COMPLETED
Hyperlipidemia Combined
Solvay Pharmaceuticals
 2005-01 PHASE3
NCT00483210 WITHDRAWN
Tissue Lipid Metabolism
University of Arkansas
NCT01141296 WITHDRAWN
Primary Biliary Cirrhosis
University of Miami
 2011-04 PHASE2
NCT00376285 WITHDRAWN
Obesity
Pfizer
 2006-11 PHASE1
NCT00006412 COMPLETED
HIV Infections; Lipodystrophy
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00349128 COMPLETED
Dyslipidemia/Glucose Metabolism Disorder
Solvay Pharmaceuticals
 2004-01 PHASE2; PHASE3
NCT00261352 TERMINATED
Type 2 Diabetes
AstraZeneca
 2005-03 PHASE3
NCT00195793 COMPLETED
Hyperlipidemia
Abbott
 2004-08 PHASE3
NCT00745407 COMPLETED
Hypertriglyceridemia
Gachon University Gil Medical Center
 2005-01 PHASE4
NCT00348725 COMPLETED
Dyslipidemia/Glucose Metabolism Disorder
Solvay Pharmaceuticals
 2005-04 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-01-08)

Check the Fenofibrate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fenofibrate acts as a selective agonist of peroxisome proliferator-activated receptor alpha (PPARα), which regulates gene expression to enhance fatty acid oxidation and stimulate cellular autophagy. This transcriptional modulation promotes lipid clearance and suppresses inflammatory responses, establishing its clinical relevance in reducing serum triglycerides and low-density lipoproteins in trials evaluating hypertriglyceridemia, metabolic syndrome, and diabetic nephropathies.

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.