If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)
Mounjaro ® (tirzepatide) injection
2.5 mg/5 mg/7.5 mg/10 mg/12.5 mg/15 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Can Mounjaro® (tirzepatide) be used in patients with type 1 diabetes?
Lilly has not studied tirzepatide in people with type 1 diabetes and it is not approved for use in these patients. SURPASS-T1D-1 and SURPASS-T1D-2 will evaluate the use of tirzepatide in participants with T1D.
See important safety information, including boxed warning, in the attached prescribing information.
Tirzepatide Use in Patients With Type 1 Diabetes
Patients with type 1 diabetes (T1D) were excluded from the tirzepatide type 2 diabetes (T2D) and weight management clinical trials. Therefore, there is no information on the use of tirzepatide in people with T1D with or without obesity.1-13
Eli Lilly and Company cannot provide treatment recommendations on the use of tirzepatide in people who have T1D.
In formulating an assessment and approach, the health care practitioner may consider
- the patient’s prior medical history and concomitant medications, and
- other individual factors.
The health care practitioner should consider potential risks and benefits of treatment options and monitor appropriately.
Ongoing Lilly Studies on Tirzepatide Use in People With Type 1 Diabetes
Ongoing Non-Lilly Studies on Tirzepatide Use in People With Type 1 Diabetes
The following are ongoing phase 2 and phase 3 clinical studies, not sponsored by Lilly, evaluating tirzepatide use in adults with T1D;
- AID-JUNCT
- TZP-T1D, and
- TIRTLE2.16-18
Please note that this may not be the full list of ongoing clinical studies available.
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Rosenstock J, Wysham C, Frías 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. Lancet. 2021;398(10295):143-155. https://doi.org/10.1016/S0140-6736%2821%2901324-6
2Frías JP, Davies MJ, Rosenstock J, et al; SURPASS-2 Investigators. Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes. N Engl J Med. 2021;385(6):503-515. https://doi.org/10.1056/NEJMoa2107519
3Ludvik B, Giorgino F, Jódar E, et al. Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial. Lancet. 2021;398(10300):583-598. https://doi.org/10.1016/S0140-6736(21)01443-4
4Del Prato S, Kahn SE, Pavo I, et al; SURPASS-4 Investigators. Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial. Lancet. 2021;398(10313):1811-1824. https://doi.org/10.1016/S0140-6736(21)02188-7
5Dahl D, Onishi Y, Norwood P, et al. Effect of subcutaneous tirzepatide vs placebo added to titrated insulin glargine on glycemic control in patients with type 2 diabetes: the SURPASS-5 randomized clinical trial. JAMA. 2022;327(6):534-545. https://doi.org/10.1001/jama.2022.0078
6Rosenstock J, Frías JP, Rodbard HW, et al. Tirzepatide vs insulin lispro added to basal insulin in type 2 diabetes: the SURPASS-6 randomized clinical trial. JAMA. 2023;330(17):1631-1640. https://doi.org/10.1001/jama.2023.20294
7Inagaki N, Takeuchi M, Oura T, et al. Efficacy and safety of tirzepatide monotherapy compared with dulaglutide in Japanese patients with type 2 diabetes (SURPASS J-mono): a double-blind, multicentre, randomised, phase 3 trial. Lancet. 2022;10(9):623-633. https://doi.org/10.1016/S2213-8587(22)00188-7
8Kadowaki T, Chin R, Ozeki A, et al. Safety and efficacy of tirzepatide as an add-on to single oral antihyperglycaemic medication in patients with type 2 diabetes in Japan (SURPASS J-combo): a multicentre, randomised, open-label, parallel-group, phase 3 trial. Lancet. 2022;10(9):634-644. https://doi.org/10.1016/S2213-8587(22)00187-5
9Gao L, Lee BW, Chawla M, et al. Tirzepatide versus insulin glargine as second-line or third-line therapy in type 2 diabetes in the Asia-Pacific region: the SURPASS-AP-Combo trial. Nat Med. 2023;29(6):1500-1510. https://doi.org/10.1038/s41591-023-02344-1
10Jastreboff AM, Aronne LJ, Ahmad NN, et al; SURMOUNT-1 Investigators. Tirzepatide once weekly for the treatment of obesity. N Engl J Med. 2022;387(3):205-216. https://doi.org/10.1056/NEJMoa2206038
11Garvey WT, Frias JP, Jastreboff AM, et al; SURMOUNT-2 investigators. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2023;402(10402):613-626. https://doi.org/10.1016/S0140-6736(23)01200-X
12Wadden TA, Chao AM, Machineni S, et al. Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Nat Med. 2023;29(11):2909-2918. https://doi.org/10.1038/s41591-023-02597-w
13Aronne LJ, Sattar N, Horn DB, et al; SURMOUNT-4 Investigators. Continued treatment with tirzepatide for maintenance of weight reduction in adults with obesity: the SURMOUNT-4 randomized clinical trial. JAMA. 2024;331(1):38-48. https://doi.org/10.1001/jama.2023.24945
14A study of tirzepatide (LY3298176) compared with placebo in adults with type 1 diabetes and obesity or overweight (SURPASS-T1D-1). ClinicalTrials.gov identifier: NCT06914895. Updated April 13, 2025. Accessed April 21, 2025. https://clinicaltrials.gov/study/NCT06914895
15A long-term study of tirzepatide (LY3298176) in adults with type 1 diabetes and obesity or overweight (SURPASS-T1D-2). ClinicalTrials.gov identifier: NCT06962280. Updated May 8, 2025. Accessed May 12, 2025.https://clinicaltrials.gov/study/NCT06962280?term=SURPASS-T1D-2&rank=1
16GIP/GLP-1RA as adjunctive to automated insulin delivery in adults with type 1 diabetes (AID-JUNCT). ClinicalTrials.gov identifier: NCT06630585. Updated October 18, 2024. Accessed April 21, 2025. https://clinicaltrials.gov/study/NCT06630585
17Tirzepatide for the treatment of concurrent type 1 diabetes and overweight or obesity (TZP-T1D). ClinicalTrials.gov identifier: NCT06180616. Updated June 3, 2024. Accessed April 21, 2025. https://clinicaltrials.gov/study/NCT06180616
18Acute metabolic effects of tirzepatide in type 1 diabetes (TIRTLE2). ClinicalTrials.gov identifier: NCT06820281. Updated February 19, 2025. Accessed April 21, 2025. https://clinicaltrials.gov/study/NCT06820281
Date of Last Review: April 21, 2025