Cited Literature

Primary clinical trial publications

^[1] Rosenstock J, Wysham C, Frias JP, et al. Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. The Lancet. 2021. DOI: 10.1016/S0140-6736(21)01324-601324-6) · PMID 34186022

^[2] Frias JP, Davies MJ, Rosenstock J, et al. Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes. New England Journal of Medicine. 2021. DOI: 10.1056/NEJMoa2107519

^[3] Del Prato S, Kahn SE, Pavo I, et al. Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial. The Lancet. 2021. DOI: 10.1016/S0140-6736(21)02188-702188-7)

^[4] Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide Once Weekly for the Treatment of Obesity (SURMOUNT-1). New England Journal of Medicine. 2022. DOI: 10.1056/NEJMoa2206038

^[5] Jastreboff AM, le Roux CW, Stefanski A, et al. Tirzepatide for Obesity Treatment and Diabetes Prevention (SURMOUNT-1, 176-week extension). New England Journal of Medicine. 2025. DOI: 10.1056/NEJMoa2410819

^[6] Wadden TA, Chao AM, Machineni S, et al. Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Nature Medicine. 2023. DOI: 10.1038/s41591-023-02597-w

^[7] Aronne LJ, Sattar N, Horn DB, et al. Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial. JAMA. 2024. DOI: 10.1001/jama.2023.24945 · PMID 38078870

^[8] Malhotra A, Grunstein RR, Fietze I, et al. Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity (SURMOUNT-OSA). New England Journal of Medicine. 2024. DOI: 10.1056/NEJMoa2404881

^[9] Packer M, Zile MR, Kramer CM, et al. Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity (SUMMIT). New England Journal of Medicine. 2025. DOI: 10.1056/NEJMoa2410027

^[10] Loomba R, Hartman ML, Lawitz EJ, et al. Tirzepatide for Metabolic Dysfunction-Associated Steatohepatitis with Liver Fibrosis (SYNERGY-NASH, Phase 2). New England Journal of Medicine. 2024. DOI: 10.1056/NEJMoa2401943

Mechanism, pharmacology, and pharmacokinetics

^[11] 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

^[12] Urva S, Quinlan T, Landry J, et al. Population pharmacokinetics of the GIP/GLP receptor agonist tirzepatide. Clinical Pharmacokinetics. 2023. DOI: 10.1007/s40262-023-01293-9

^[13] (Reserved — see ^[12] for population PK and ^[17] for label PK summary.)

^[14] de Boer IH, Khunti K, Sadusky T, et al. Systolic blood pressure reduction with tirzepatide in patients with type 2 diabetes: insights from the SURPASS clinical program. Cardiovascular Diabetology. 2023. DOI: 10.1186/s12933-023-01798-4

^[15] Aronne LJ, et al. Pooled safety and tolerability analysis of tirzepatide in adults with obesity or overweight across the SURMOUNT clinical trial program. Obesity (Silver Spring). 2025. DOI: 10.1002/oby.24222

^[16] Andreadi A, et al. Insights into the Mechanism of Action of Tirzepatide: A Narrative Review. Diabetes Therapy. 2025. DOI: 10.1007/s13300-025-01804-w

^[20] Sun B, Willard FS, Feng D, et al. Structural determinants of dual incretin receptor agonism by tirzepatide. Proceedings of the National Academy of Sciences. 2022. DOI: 10.1073/pnas.2116506119

FDA labeling and regulatory documents

^[17] U.S. Food and Drug Administration. Tirzepatide Prescribing Information (FDA Label). 2025. Available at: accessdata.fda.gov/drugsatfda_docs/label/2025/217806s031lbl.pdf

^[18] U.S. Food and Drug Administration. Declaratory Order: Resolution of Shortages of Tirzepatide Injection Products. 2024. Available at: fda.gov/media/184606/download

^[19] U.S. Food and Drug Administration. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize. 2024. Available at: fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize

How citations are used on this site

Every quantitative claim on Tirzepatide / Get — every dose number, every percentage, every trial outcome, every regulatory date — is sourced to one of the references above. Inline brackets like ^[4] link to the matching entry in this list.

Where two or more references support the same statement, all relevant brackets appear. Where the regulatory record is the primary source (as with the dose schedule, the missed-dose rule, the boxed warning, the shortage resolution dates, and the compounding grace periods), the FDA documents at ^[17], ^[18], and ^[19] are cited rather than secondary commentary.