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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.
Does Mounjaro® (tirzepatide) affect liver function tests like AST and ALT?
Changes in AST and ALT were evaluated in the tirzepatide clinical trials in adults with type 2 diabetes.
See important safety information, including boxed warning, in the attached prescribing information.
Clinical Trial Liver Function Tests
SURPASS Clinical Trial Program
Changes in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were evaluated in SURPASS-1, -2 -3, -5 and -6 studies (Summary of Liver Enzymes in SURPASS Studies Using mITT-Safety Analysis Set,).1-5
In the SURPASS clinical trial program, participants were excluded if they met any of the following criteria at screening:
- had acute or chronic hepatitis
- had signs and symptoms of any liver disease other than metabolic dysfunction–associated steatotic liver disease (MASLD), formerly known as nonalcoholic fatty liver disease (NAFLD), and
- ALT level >3.0 times the upper limit of normal (ULN) for the reference range. Participants with MASLD were eligible to participate in the trial if their ALT level was ≤3.0 times the ULN for the reference range.1,2
Parameterb |
Tirzepatide 5 mg |
Tirzepatide 10 mg |
Tirzepatide 15 mg |
Comparatorc |
SURPASS-1 |
N=121 |
N=121 |
N=121 |
N=115 |
AST, % CFB (U/L) |
-11.6 |
-9.5 |
-13.9 |
-2.6 |
ALT, % CFB (U/L) |
-29.1 |
-25.7 |
-32.9 |
-10.2 |
SURPASS-2 |
N=470 |
N=469 |
N=470 |
N=469 |
AST, % CFB (U/L) |
-8.72 |
-13.73 |
-14.10 |
-9.20 |
ALT, % CFB (U/L) |
-22.4 |
-29.2 |
-30.0 |
-21.6 |
SURPASS-3 |
N=358 |
N=360 |
N=359 |
N=360 |
AST, % CFB (U/L) |
-11.40*** |
-12.77*** |
-16.42*** |
-5.75**** |
ALT, % CFB (U/L) |
-22.3*** |
-27.4*** |
-30.7*** |
-17.0*** |
SURPASS-5 |
N=116 |
N=119 |
N=120 |
N=120 |
AST, % CFB (U/L) |
-4.12 |
-8.56* |
-14.07** |
0.02 |
ALT, % CFB (U/L) |
-19.4* |
-23.3* |
-28.3** |
-7.5 |
SURPASS-6 |
N=243 |
N=238 |
N=236 |
N=708 |
AST, % CFB (U/L) |
-6.4 |
-7.0 |
-8.2 |
5.6 |
ALT, % CFB (U/L) |
-15.9 |
-15.4 |
-21.0 |
2.3 |
Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CFB = change from baseline; mITT = modified intention-to-treat; N = all randomly assigned participants.
*p<.05, **p<.001, ***p<.0001, ****p=.0005
aSafety data included all data through safety follow-up from the mITT population.
bAnalysis with log transformation.
cComparators were placebo in SURPASS-1 and SURPASS-5 for 40 weeks, semaglutide 1 mg once weekly in SURPASS-2 for 40 weeks, titrated insulin degludec in SURPASS-3 for 52 weeks, titrated insulin glargine in SURPASS-4 for 52 weeks, and insulin lispro in SURPASS-6 for 52 weeks.
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
4Dahl 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
5Rosenstock 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
Date of Last Review: September 23, 2024