Tirzepatide for the Management of Cardiovascular Risk in Type 2 Diabetes: An Individual Participant Data Meta-analysis of Phase 3 Randomized Clinical Trials

Authors: Arya Aminorroaya, MD, MPH, Evangelos K. Oikonomou, MD, DPhil, Dhruva Biswas, MD, PhD, Ania M. Jastreboff, MD, PhD, Rohan Khera, MD, MS

Funding: The authors acknowledge funding through the National Institutes of Health (NIH) under awards F32HL170592 (EKO), R01DK099039, R01DK136623, R01DK134398 (AMJ), R01AG089981, R01HL167858, and K23HL153775 (RK) and the Doris Duke Charitable Foundation under award 2022060 (RK). The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Disclosures: EKO receives support from the National Heart, Lung, and Blood Institute of the National Institutes of Health (under award F32HL170592). He is named as a co-inventor in patent applications (18/813,882, 17/720,068, 63/508,315, 63/580,137, 63/619,241, 63/562,335) and granted patents (US12067714B2, US11948230B2), has been a consultant for Caristo Diagnostics Ltd and Ensight-AI, Inc., and has received royalty fees from technology licensed through the University of Oxford, outside this work. AMJ conducts multicenter trials with Amgen, Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Rhythm Pharmaceuticals. She serves on scientific advisory boards for Amgen, AstraZeneca, Biohaven, Boehringer Ingelheim, Eli Lilly, Intellihealth, Novo Nordisk, Pfizer, Regeneron Pharmaceuticals, Scholar Rock, Structure Therapeutics, Terns Pharmaceuticals, WeightWatchers, and Zealand Pharma. RK is an Associate Editor of JAMA. He receives research support through Yale from Bristol-Myers Squibb, Novo Nordisk, BridgeBio, and the Blavatnik Family Foundation. He is a co-inventor of US Provisional Patent Applications WO2023230345A1, US20220336048A1, 63/346,610, 63/484,426, 63/508,315, 63/580,137, 63/606,203, 63/619,241, 63/562,335 and 18/813,882, all unrelated to the current work. EKO and RK are co-founders of Evidence2Health, a precision health platform to improve evidence-based cardiovascular care. RK is an academic co-founder of Ensight-AI, Inc., an AI-ECG analytics company. All other authors declare no competing interests.

Acknowledgments: The authors would like to thank Vivli, an independent, non-profit organization that has developed a global data-sharing and analytics platform, for providing access to the data and a secure analytical platform. This study is based on research using data from data contributors Eli Lilly that has been made available through Vivli, Inc. Vivli has not contributed to or approved, and Vivli and Eli Lilly are not in any way responsible for, the contents of this publication.

Data Sharing: We obtained access to the data following the approval of our proposal by an independent review committee and the signing of a data-sharing agreement. The data and documents—including the study protocol, statistical analysis plan, and annotated case report forms—were made available in a secure data-sharing environment. Detailed instructions for obtaining access are provided at https://vivli.org/.