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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.
What is the effect of Mounjaro® (tirzepatide) on fasting serum glucose?
Tirzepatide treatment consistently improved fasting serum glucose in adults with type 2 diabetes.
See important safety information, including boxed warning, in the attached prescribing information.
Improved Fasting Serum Glucose in SURPASS Studies
Tirzepatide is a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D) for once-weekly, subcutaneous administration.1
In the SURPASS clinical trial program, treatment with tirzepatide 5, 10, and 15 mg was associated with improved fasting serum glucose (FSG) compared to baseline in adults with T2D compared with placebo, semaglutide 1 mg injection, titrated insulin degludec, titrated insulin glargine, and titrated insulin lispro (Summary of Fasting Serum Glucose in SURPASS Studies).2-7
Two statistical estimands, efficacy or treatment-regimen, were used to evaluate efficacy data from the phase 3 clinical trials of tirzepatide. Efficacy estimand evaluates the treatment effect prior to discontinuation of the study drug. Treatment-regimen estimand evaluates the treatment effect irrespective of adherence to the study drug. Differences in reported data may reflect the application of these estimands. This response presents data reflecting the efficacy estimand. For treatment-regimen estimand results, please refer to the manuscript cited and/or the US prescribing information, where applicable.
FSG, mg/dLa |
Tirzepatide 5 mg |
Tirzepatide 10 mg |
Tirzepatide 15 mg |
Comparatorb |
||||
SURPASS-1 |
||||||||
FSG at baseline |
153.7±3.7 |
152.6±3.7 |
154.6±3.7 |
155.2±3.8 |
||||
FSG change from baseline |
-43.6±3.4 |
-45.9±3.5 |
-49.3±3.6 |
12.9±4.0 |
||||
Difference vs placeboc |
-56.5 (-66.8, -46.1)*** |
-58.8 (-69.2, -48.4)*** |
-62.1 (-72.7, -51.5)*** |
-- |
||||
SURPASS-2 |
||||||||
FSG at baseline |
174.2±2.39 |
174.6±2.40 |
172.3±2.39 |
170.9±2.40 |
||||
FSG change from baseline |
-56.0±1.57 |
-61.6±1.60 |
-63.4±1.59 |
-48.6±1.58 |
||||
Difference vs semaglutide |
-7.3 (-11.7, -3.0)** |
-13.0 (-17.4, -8.6)*** |
-14.7 (-19.1, -10.3)*** |
-- |
||||
SURPASS-3 |
||||||||
FSG at baseline |
171.8±2.44 |
170.7±2.44 |
168.4±2.44 |
166.4±2.44 |
||||
FSG change from baseline |
-48.2±1.82 |
-54.8±1.86 |
-59.2±1.85 |
-55.7±1.81 |
||||
Difference vs insulin degludec |
7.5 (2.4, 12.5)** |
0.8 (-4.3, 5.9) |
-3.6 (-8.7, 1.5) |
-- |
||||
SURPASS-4 |
||||||||
FSG at baseline |
172.3±2.81 |
175.7±2.84 |
174.2±2.78 |
168.7±1.62 |
||||
FSG change from baseline |
-50.4±2.07 |
-54.9±2.06 |
-59.3±2.04 |
-51.4±1.17 |
||||
Difference vs insulin glargine |
1.0 (-3.7, 5.7) |
-3.6 (-8.2, 1.1) |
-8.0 (-12.6, -3.4)*** |
-- |
||||
SURPASS-5 |
||||||||
FSG at baseline |
162.2±4.81 |
162.9±4.79 |
160.4±4.75 |
164.4±4.75 |
||||
FSG change from baseline |
-61.4±2.55 |
-67.9±2.55 |
-67.7±2.64 |
-38.9±2.49 |
||||
Difference vs placeboc |
-22.5 (-29.5, -15.4)*** |
-29.0 (-36.0, -22.0)*** |
-28.8 (-35.9, -21.6)*** |
-- |
||||
SURPASS-6 |
||||||||
FSG at baseline |
163.4±3.61 |
155.6±3.65 |
156.4±3.67 |
156.0±2.13 |
||||
FSG change from baseline |
-33.2±3.28 |
-43.0±3.32 |
-41.6±3.42 |
-10.0±1.99 |
||||
Difference vs insulin lispro |
-23.2 (-30.8, -15.7)*** |
-33.0 (-40.6, -25.4)*** |
-31.6 (-39.3, -23.8)*** |
-- |
||||
Abbreviations: FSG = fasting serum glucose; LSM = least squares mean; mITT = modified intention-to-treat; MMRM = mixed model repeated measures.
Efficacy estimand evaluates the treatment effect prior to discontinuation of the study drug without confounding effects of antihyperglycemic rescue therapy. Analyzed by MMRM using the mITT population (efficacy analysis set).
**p<.01, and ***p<.001 versus comparator.
aData are LSM±SE at baseline and change from baseline at endpoint and treatment differences are LSM (95% CI).
bComparator was placebo in SURPASS-1 and SURPASS-5 for 40 weeks. Comparator was semaglutide 1 mg once weekly in SURPASS-2 for 40 weeks. Comparator was titrated insulin degludec in SURPASS-3 for 52 weeks. Comparator was titrated insulin glargine in SURPASS-4 for 52 weeks. Comparator was titrated insulin lispro in SURPASS-6 for 52 weeks.
cTested for superiority, controlled for type 1 error.
SURPASS Study Summaries
SURPASS-1 was a 40-week, phase 3, double-blind, randomized study of tirzepatide 5, 10, and 15 mg once weekly as monotherapy compared with placebo in 478 adults with T2D inadequately controlled with diet and exercise alone.2
SURPASS-2 was a 40-week, phase 3, open-label, randomized study of tirzepatide 5, 10, and 15 mg once weekly compared with semaglutide 1 mg once weekly as add-on therapy to metformin in 1879 adults with T2D.3
SURPASS-3 was a 52-week, phase 3, open-label study of tirzepatide 5, 10, and 15 mg once weekly compared with titrated insulin degludec daily in 1444 adults with T2D inadequately controlled on metformin with or without a sodium-glucose cotransporter-2 (SGLT-2) inhibitor.9
SURPASS-4 was a 52-week, phase 3, open-label, parallel-group, randomized study comparing tirzepatide 5, 10, and 15 mg once weekly with titrated insulin glargine once daily added to at least 1 and up to 3 oral antihyperglycemic medications (OAMs) [metformin, sulfonylureas, or sodium-glucose cotransporter-2 (SGLT-2) inhibitors] in 2002 adults with T2D and increased cardiovascular risk.5
SURPASS-5 was a 40-week, phase 3, double-blind, randomized study of tirzepatide 5, 10, and 15 mg once weekly compared with placebo in 475 adults with T2D, as add-on to titrated insulin glargine with or without metformin.6
SURPASS-6 was a 52-week, phase 3b, open-label, multicenter, parallel-group, randomized study of tirzepatide 5, 10, and 15 mg once weekly compared with prandial insulin lispro 3 times daily in 1428 adults with T2D as add-on to titrated insulin glargine with or without metformin.7
The number of study participants randomly assigned to a treatment group and who took at least 1 dose of the study drug for all available SURPASS trials are summarized in Summary of Study Participants Randomized to Treatment Groups for SURPASS Studies at Baseline .2-7
Study |
Tirzepatide 5 mg |
Tirzepatide 10 mg |
Tirzepatide 15 mg |
Comparatora |
SURPASS-1 |
121 |
121 |
121 |
115 |
SURPASS-2 |
470 |
469 |
470 |
469 |
SURPASS-3 |
358 |
360 |
359 |
360 |
SURPASS-4 |
329 |
328 |
338 |
1000 |
SURPASS-5 |
116 |
119 |
120 |
120 |
SURPASS-6 |
243 |
238 |
236 |
708 |
Abbreviations: N = all randomly assigned participants who took at least 1 dose of the study drug.
aComparators 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).
1Mounjaro [package insert]. Indianapolis, IN: Eli Lilly and Company; 2023.
2Rosenstock 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
3Frías 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
4Ludvik 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
5Del 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
6Dahl 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
7Rosenstock 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. Published online October 3, 2023. https://doi.org/10.1001/jama.2023.20294
8Data on file, Eli Lilly and Company and/or one of its subsidiaries.
9Ludvik 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
Date of Last Review: September 12, 2023