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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 people with autoimmune disorders other than plaque psoriasis, psoriatic arthritis, ulcerative colitis, or Crohn's?
Tirzepatide has not been studied in people with significant and active autoimmune disorders other than PsA, PsO, UC, or CD. Lilly cannot provide treatment recommendations on the use of tirzepatide in people with these conditions.
See important safety information, including boxed warning, in the attached prescribing information.
Can Tirzepatide be Used in People With Autoimmune Disorders?
No information is available on the use of tirzepatide in patients with significant and active autoimmune abnormalities such as, but not limited to, lupus, multiple sclerosis, or rheumatoid arthritis. Participants were excluded from clinical trials if they were receiving, or likely to require systemic glucocorticoids during the course of the study.1-9
Clinical Considerations
Eli Lilly and Company cannot provide treatment recommendations on the use of tirzepatide in patients with a history of a significant and active autoimmune disorder. In formulating an assessment and approach, the health care practitioner may consider
- the information provided
- 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.
Tirzepatide Psoriatic Arthritis and Plaque Psoriasis Studies
In clinical studies conducted by Lilly to assess the safety and efficacy of ixekizumab and ixekizumab with concomitantly administered tirzepatide, patients enrolled must have
- moderate-to-severe plaque psoriasis and obesity or overweight, or
- psoriatic arthritis and obesity or overweight.
Participants with type 2 diabetes (T2D) were eligible for enrollment unless they required treatment with insulin.10-12
Tirzepatide Ulcerative Colitis and Crohn's Disease Studies
A phase 3b study, COMMIT-UC, is being conducted in adult patients with moderately to severely active ulcerative colitis and obesity or overweight to determine if treatment with mirikizumab plus tirzepatide compared with mirikizumab plus placebo leads to decrease or disappearance of ulcerative colitis symptoms, and at least a 10% reduction in body weight.13
A phase 3b study, COMMIT-CD, is being conducted to assess the efficacy and safety of mirikizumab plus placebo compared with mirikizumab plus tirzepatide in adult patients with moderately to severely active Crohn's disease and obesity or overweight.14
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
6Jastreboff 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
7Garvey 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
8Wadden 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
9Aronne 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
10Ixekizumab concomitantly administered with tirzepatide in adults with psoriatic arthritis and obesity or overweight (TOGETHER-PsA). ClinicalTrials.gov identifier: NCT06588296. Updated January 21, 2026. Accessed March 3, 2026. https://clinicaltrials.gov/study/NCT06588296
11Ixekizumab concomitantly administered with tirzepatide in adults with moderate-to-severe plaque psoriasis and obesity or overweight (TOGETHER-PsO). ClinicalTrials.gov identifier: NCT06588283. Updated January 20, 2026. Accessed March 17, 2026. https://clinicaltrials.gov/study/NCT06588283
12Merola JF, Mease P, Kivitz A, et al. Ixekizumab with tirzepatide achieved greater disease control than ixekizumab alone in adults with psoriatic arthritis and overweight or obesity: results from a randomized clinical trial. Arthritis Rheumatol. Published online March 28, 2026. https://doi.org/10.1002/art.70134
13Mirikizumab administered at the same time as tirzepatide in adult participants with moderately to severely active ulcerative colitis and obesity or overweight: phase 3b study (COMMIT-UC). ClinicalTrials.gov identifier: NCT06937086. Updated April 22, 2025. Accessed April 22, 2025. https://clinicaltrials.gov/study/NCT06937086
14Mirikizumab and tirzepatide concomitantly administered in adult participants with moderately to severely active Crohn’s disease and obesity or overweight: phase 3b study (COMMIT-CD). ClinicalTrials.gov identifier: NCT06937099. Updated April 22, 2025. Accessed April 22, 2025. https://clinicaltrials.gov/study/NCT06937099
Date of Last Review: March 28, 2026