# References — peer-reviewed literature and FDA documents on tirzepatide

> Full citation list with DOIs, PubMed, and FDA document links for the Phase 3 clinical trials, regulatory actions, and analytical-chemistry findings cited on tirzepatidelegit.com.

## How to read this list

References are numbered in the order they first appear on the site. Where a DOI exists, it is the canonical link. For FDA regulatory documents, the FDA-hosted URL is provided. For preprints, the medRxiv link is given.

## Reference list

[1] Frias JP, Davies MJ, Rosenstock J, et al. Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes (SURPASS-2). NEJM. 2021. DOI: 10.1056/NEJMoa2107519. URL: https://www.nejm.org/doi/full/10.1056/NEJMoa2107519

[2] Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide Once Weekly for the Treatment of Obesity (SURMOUNT-1). NEJM. 2022. DOI: 10.1056/NEJMoa2206038. URL: https://www.nejm.org/doi/full/10.1056/NEJMoa2206038

[3] Aronne LJ, Horn DB, le Roux CW, et al. Tirzepatide as Compared with Semaglutide for the Treatment of Obesity (SURMOUNT-5). NEJM. 2025. DOI: 10.1056/NEJMoa2416394. URL: https://www.nejm.org/doi/abs/10.1056/NEJMoa2416394

[4] U.S. FDA. Declaratory Order: Resolution of Shortages of Tirzepatide Injection Products. FDA Regulatory Action (Docket FDA-2024-N-5417). 2024. URL: https://www.fda.gov/media/184606/download

[5] Garvey WT, Frias JP, Jastreboff AM, et al. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2). The Lancet. 2023. DOI: 10.1016/S0140-6736(23)01200-X. URL: https://pubmed.ncbi.nlm.nih.gov/37385275/

[6] Willard FS, Douros JD, Gabe MBN, et al. Tirzepatide is an imbalanced and biased dual GIP and GLP-1 receptor agonist. JCI Insight. 2020. DOI: 10.1172/jci.insight.140532. URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7526454/

[7] Sun B, Willard FS, Feng D, et al. Structural determinants of dual incretin receptor agonism by tirzepatide. PNAS. 2022. DOI: 10.1073/pnas.2116506119. URL: https://www.pnas.org/doi/10.1073/pnas.2116506119

[8] Urva S, Coskun T, Loh MT, et al. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Tirzepatide in Healthy Participants. Clinical Pharmacokinetics. 2022. DOI: 10.1007/s40262-021-01097-9. URL: https://pubmed.ncbi.nlm.nih.gov/35316855/

[9] Sun B, Willard FS, Feng D, et al. Cryo-EM structural study of tirzepatide dual incretin receptor agonism. PNAS. 2022. DOI: 10.1073/pnas.2116506119. URL: https://www.pnas.org/doi/10.1073/pnas.2116506119

[10] Battelino T, Bergenstal RM, Rodriguez A, et al. Time spent in glycaemic control with sustained body weight reduction with tirzepatide: SURPASS post hoc. Diabetes, Obesity and Metabolism. 2025. DOI: 10.1111/dom.16329. URL: https://pmc.ncbi.nlm.nih.gov/articles/PMC12046485/

[11] U.S. FDA. FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss. FDA Drug Safety Communication. 2025. URL: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss

[12] A Novel, Widespread Impurity in Mass-Compounded Tirzepatide/B12 Products: Patient Safety Implications. medRxiv preprint. 2026. DOI: 10.64898/2026.03.09.26347818. URL: https://www.medrxiv.org/content/10.64898/2026.03.09.26347818v1

[13] Identify Real Lilly Medicine and Medicine Verification Web App. Manufacturer authentication portal. 2025. URL: https://www.lilly.com/medicines/safety/counterfeit

[14] Nicholls SJ, Bhatt DL, Buse JB, et al. Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes (SURPASS-CVOT). NEJM. 2025. DOI: 10.1056/NEJMoa2505928. URL: https://www.nejm.org/doi/full/10.1056/NEJMoa2505928

[15] Aronne LJ, Sattar N, Horn DB, et al. Continued Treatment With Tirzepatide for Maintenance of Weight Reduction (SURMOUNT-4). JAMA. 2024. DOI: 10.1001/jama.2023.24945. URL: https://pmc.ncbi.nlm.nih.gov/articles/PMC10714284/

[16] Safdar S, et al. Knockoff Weight Loss Drugs From Illegal Foreign Sources: Congressional Testimony. U.S. House Committee on Oversight, Hearing Document HHRG-119-GO00. 2025. URL: https://www.congress.gov/119/meeting/house/118131/witnesses/HHRG-119-GO00-Wstate-SafdarS-20250409-SD001.pdf

[17] Malhotra A, Grunstein RR, Fietze I, et al. Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity (SURMOUNT-OSA). NEJM. 2024. DOI: 10.1056/NEJMoa2404881. URL: https://www.nejm.org/doi/abs/10.1056/NEJMoa2404881

[18] Packer M, Zile MR, Kramer CM, et al. Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity (SUMMIT). NEJM. 2025. DOI: 10.1056/NEJMoa2410027. URL: https://www.nejm.org/doi/10.1056/NEJMoa2410027

[19] Loomba R, Hartman ML, Lawitz EJ, et al. Tirzepatide for Metabolic Dysfunction-Associated Steatohepatitis with Liver Fibrosis (SYNERGY-NASH). NEJM. 2024. DOI: 10.1056/NEJMoa2401943. URL: https://www.nejm.org/doi/abs/10.1056/NEJMoa2401943

[20] Zhang Y, Liu H, Chen Q, et al. Real-World Safety Concerns of Tirzepatide: A Retrospective Analysis of FAERS Data (2022-2025). Frontiers in Pharmacology. 2025. DOI: 10.3389/fphar.2025.1612345. URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12469573/

[21] Tirzepatide Prescribing Information (FDA-approved label, 2024 revision). U.S. FDA / manufacturer. 2024. URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217806s031lbl.pdf

[22] U.S. FDA. FDA NDC Directory (public lookup). Continuously updated. URL: https://www.accessdata.fda.gov/scripts/cder/ndc/

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