812-P: The Role of Industry and NIH/Academia in the Clinical Development of GLP-1 Agonists and SGLT2 Inhibitors

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GLP-1 agonists and SGLT2 inhibitors are increasingly prescribed as second line agents for type 2 diabetes. However, costs for these drugs are high. Pharmaceutical manufacturers often cite high development costs as a justification for high prices. Therefore, we sought to characterize the role of NIH/academia in the development of these drugs. We used clinicaltrials.gov to assess US clinical trials of GLP-1 agonists and SGLT2i. We used NIH Reporter to determine if lead investigators received diabetes or cardiovascular NIH grants as a measure of indirect NIH support. We examined 200 GLP-1 agonist and 104 SGLT2i phase 3 clinical trials. For GLP-1 agonists, 179(90%) were sponsored by industry and 21(10%) were sponsored by NIH/academia. For SGLT2i, 93(89%) and 11(11%) were sponsored by industry and NIH/academia, respectively. Of the 179 phase 3 industry-sponsored GLP-1 agonist trials, 52% were led by NIH-supported scientists. For the 93 phase 3 industry-sponsored SGLT2i trials, 42% were led by NIH-supported scientists. When sponsorship was analyzed by drug, we found exenatide and canagliflozin, the first FDA approved drugs of each class, received more public support than other drugs in the same class. Our findings suggest that public support by direct NIH sponsorship or intellectual leadership by NIH-supported scientists was substantial in the development of GLP-1 agonists and SLGT2 inhibitors.View largeDownload slideView largeDownload slide DisclosureB. R. Kocak: None. Z. Kassir: None. J. Luo: Consultant; Self; Alosa Health, Research Support; Self; Health Action International.