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Article History

Received: 10 October 2025

Accepted: 9 February 2026

First Online: 7 March 2026

Declarations

:

: Shraddha Shinde, Chisom Kanu, Oralee J. Varnado, Jo Bednarik, and Ellen B. Dennehy are employees and minor shareholders of Eli Lilly, which funded this study. Carla Dias-Barbosa and Natalie Taylor are employees of PPD™ Evidera™ Patient-Centered Research, part of Thermo Fisher Scientific, which received funding from Eli Lilly for work on this study.

: Ethics approval was obtained from a US central institutional review board (Advarra, 12 September, 2023) and a German ethics committee (Schleswig-Holstein Medical Association, 18 December, 2023) before participant recruitment.

: All study participants provided written informed consent.

: Not applicable.

: Lilly provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the US and European Union and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at .

: Not applicable.

: SS: conceptualization, methodology, writing (review and editing), project administration, funding acquisition; CK: conceptualization, methodology, writing (review and editing); OJV: writing (review and editing), project administration; JB: conceptualization, methodology, writing (review and editing); EBD: writing (review and editing); CD-B: conceptualization, methodology, validation, formal analysis, investigation, resources, data curation, writing (original draft), writing (review and editing), visualization, supervision, project administration, funding acquisition; NT: conceptualization, methodology, validation, formal analysis, investigation, resources, data curation, writing (review and editing), supervision, project administration, funding acquisition.