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Article History

Received: 4 December 2025

Accepted: 11 March 2026

First Online: 21 May 2026

Acknowledgements

: The authors acknowledge and thank B. Frier (The Queen’s Medical Research Institute, University of Edinburgh, UK) and D. Muchmore (Kinexum Services, USA) for assistance with protocol design and L. Heinemann (Science Consulting in Diabetes, Germany) for assistance with protocol design and manuscript review. The authors would also like to thank the research staff at Centricity Research for their exemplary conduct of the study procedures.

: Elements of the information presented in this publication are available at ClinicalTrials.gov (NCT05007977). The study protocol and de-identified individual participant data can be requested from the study sponsor (Zucara Therapeutics Inc.) for academic non-commercial research purposes and may be made available, based on approval of the researcher’s study plan, beginning 3 months after and ending 12 months after publication of this article.

: The study was funded by the sponsor, Zucara Therapeutics Inc. The study sponsor/funder was involved in the study design; data analysis and interpretation and writing the report. The funder was not involved in the data collection. The University of Cambridge has received salary support for ME from the National Health Service in the East of England through the Clinical Academic Reserve.

: RL, ES and SP are employees of the study sponsor, Zucara Therapeutics Inc. and RL, ES, SP and MR are shareholders or stock option holders of the company. RL and ES are inventors named in a patent relating to ZT-01. MR, ME and FKK were members of Zucara’s Clinical Advisory Board during the conduct of this study. The authors declare that there are no other relationships or activities that might bias, or be perceived to bias, their work.

: All authors contributed to the study protocol design, reviewed the data and contributed to its interpretation. RL wrote the first draft of the manuscript with input from SP, AA and MR. MR, ES, ME, FKK and AA reviewed and edited the manuscript. RL, SP, ES and AA accessed and verified the data from this study. All authors had access to the data and were responsible for the final decision to submit for publication. AA, the study’s principal investigator, is the guarantor of this work.