PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA
Thetis Pharmaceuticals LLC
The primary objective of the study is to contrast the pharmacokinetic profiles of metformin
and EPA delivered separately as co-administered products (metformin hydrochloride or
Glucophage and icosapent ethyl or Vascepa) and together as the solid dose form (metformin
eicosapentaenoate or TP-101) under fasted and fed conditions. A secondary objective is to
evaluate the safety and tolerability of single and repeat single doses of TP-101.
Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects
Brigham and Women's Hospital
This pilot trial seeks to obtain preliminary data on the effects of eicosapentaenoic acid
(EPA) (4g/d) on endothelial function measured via endopat2000 after 12 weeks of intervention
among adults with elevated triglycerides and type 2 diabetes.
Impact of Icosapent Ethyl on Alzheimers Disease Biomarkers in Preclinical Adults
Not yet recruiting
University of Wisconsin, Madison
Phase 2/Phase 3
The number of Americans diagnosed with Alzheimer's disease (AD) is expected to triple by
2050. Compared to the general population, Veterans have a greater risk of AD, likely in part
due to their increased incidence of traumatic brain injury, post-traumatic stress disorder,
depression, and other vascular-related health issues. Based on available data, 423,000 new
cases of AD are anticipated in Veterans by 2020. Thus, the discovery of effective therapies
to prevent or delay the onset of AD in Veterans is critical. The goal of this study is to
evaluate the efficacy of a purified form of the omega-3 fatty acid eicosapentaenoic acid
(EPA) called icosapent ethyl (IPE), on improving brain blood flow, spinal fluid markers of
AD pathology, and cognitive performance in middle-aged, cognitively-healthy Veterans with
increased risk of AD. If IPE delays the onset of AD by even 5 years, the incidence of AD
would be reduced by 50% in this population and could have a profound effect on Veteran
quality of life and healthcare costs.
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