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Article History

Received: 19 December 2024

Accepted: 26 February 2025

First Online: 21 March 2025

Declarations

:

: Yuki Otani, Rodrigo Escobar, Nathan J. Morris, Christopher D. Payne, Michelle Ugolini Lopes, and Xin Zhang are employees and shareholders of Eli Lilly and Company. Brian G. Feagan has received consulting fees from AbbVie, Abivax, Adiso, AgomAB Therapeutics, Akros, Alira Health, Ally Bridge Group, AnaptysBio, Apini Therapeutics, Argenx, Avoro Capital Advisors, Belmore Law, BioFactura, BioJamp, Biora Therapeutics, Blackbird Laboratories, Boehringer Ingelheim, Boxer Capital, Celsius Therapeutics, Celgene/BMS, Celltrion, Clarivate, Connect BioPharma, Disc Medicine, Duality, EcoR1, Eli Lilly, Ensho Therapeutics, Evida, Enveda, Faes Farma, First Wave, Forbion, Galapagos, Galen Atlantica, Genentech/Roche, General Atlantic, Genesis Therapeutics, Gilead, Gossamer Pharma, GSK, Imhotex, ImmiDomics, Immunic Therapeutics, Intercept, Janssen, Japan Tobacco Inc., Klick Health, LifeMine Therapeutics, Mage Biologics, Merck, Mestag, Mirador Therapeutics, Mobius, Monte Rosa Tx, Morphic Therapeutics, Nexys Therapeutics, Nighthawk Therapeutics, Nimbus Therapeutics, Novartis, OncoC4, OrbiMed, Orphagen, Pendopharm, Pfizer, Protagonist,32 Bio, REDX, Roche, Roivant/Televant, Sanofi, Sobi, Sorriso, Spyre Therapeutics, Surrozen Inc., Sun Pharma, Synedgen, Takeda, Teva, Triastek, Trex Bio, TR1X Inc. TVM Lifesciences, Ventyx Biosciences, Versant Ventures, Vida Ventures, Zagbio; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Abbvie, Takeda, Janssen, Pfizer, Eli Lilly; payment for expert testimony from Belmore Law; participation on a Data Safety Monitoring Board or Advisory Board for AbbVie, AnaptysBio, Boehringer Ingelheim, Celgene/BMS, Eli Lilly, Genentech/Roche, Janssen, Merck, MiroBio, Origo BioPharma, Pfizer, REDX Pharma, Sanofi, Takeda, Teva, Ecor1Capital, Morphic, GSK; and stock options from Connect BioPharma, EnGene. Geert R. D’Haens has served as adviser and/or speaker for Abbvie, Alimentiv, Bristol Meiers Squibb, Boehringer Ingelheim, Celltrion, Eli Lilly, Galapagos, Glaxo Smith Kline, Immunic, Index Pharmaceuticals, Johnson and Johnson, Merck, Polpharm, Prometheus biosciences, Prometheus Laboratories, Procise diagnostics, Protagonist, Sandoz, Takeda, Tillotts, and Ventyx.

: The studies were conducted in accordance with the study protocols and with consensus ethics principles derived from international ethics guidelines, including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines, applicable International Council for Harmonisation Good Clinical Practice Guidelines, and applicable laws and regulations. The study protocols were approved by the institutional review boards before all studies were initiated. Ethical review boards were in place for all studies: the WCG – Midlands Independent Review Board and WCG Independent Review Board were the overall (“master”) ethics committees for study A, and the Salus Institutional Review Board was the overall (“master”) ethics committee for studies B and C. Informed consent forms, required to provide details about why the research was being done and what it would involve, were approved by the respective review boards and provided to participants. Subsequent dated written informed consent was required by each participant before the participant could participate in the study. The informed consent forms also noted that study data which did not directly identify participants could be published.