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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 waist circumference in adults with type 2 diabetes?
In the SURPASS studies, tirzepatide demonstrated reductions in waist circumference compared to either active comparator or placebo.
See important safety information, including boxed warning, in the attached prescribing information.
Waist Circumference Changes 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 a reduction in waist circumference from baseline in adults with T2D compared with placebo, semaglutide 1 mg, titrated insulin degludec, titrated insulin glargine, and titrated insulin lispro. The summary of waist circumference changes can be found in Summary of Waist Circumference in SURPASS Studies.2-7
Waist Circumference (cm)a |
Tirzepatide 5 mg |
Tirzepatide 10 mg |
Tirzepatide 15 mg |
Comparatorb |
SURPASS-1 |
n=121 |
n=121 |
n=120 |
n=113 |
Baseline |
104.2 |
103.2 |
102.9 |
101.9 |
Waist circumference CFB |
-5.7 |
-6.9 |
-7.2 |
-2.0 |
Difference vs placebo (95% CI) |
-3.7 (-5.4, -2.1)c |
-4.9 (-6.6, -3.2)c |
-5.2 (-7.0, -3.5)c |
-- |
SURPASS-2 |
n=470 |
n=469 |
n=469 |
n=468 |
Baseline |
108.1 |
110.5 |
109.6 |
109.0 |
Waist circumference CFB |
-6.9d |
-9.6d |
-9.9d |
-5.6d |
Difference vs semaglutide 1 mg (95% CI) |
-1.3 (-2.4, -0.1)e |
-3.9 (-5.1, -2.8)f |
-4.3 (-5.4, -3.1)f |
-- |
SURPASS-3 |
n=358 |
n=360 |
n=358 |
n=359 |
Baseline |
110.7 |
110.3 |
109.8 |
110.7 |
Waist circumference CFB |
-7.1d |
-9.5d |
-10.9d |
1.3g |
Difference vs insulin degludec (95% CI) |
-8.4 (-9.5, -7.3)h |
-10.8 (-12.0, -9.7)h |
-12.2 (-13.3, -11.1)h |
-- |
SURPASS-4 |
n=328 |
n=326 |
n=337 |
n=998 |
Baseline |
109.4 |
109.2 |
108.4 |
108.3 |
Waist circumference CFB |
-7.7d |
-7.9d |
-9.7d |
0.8g |
Difference vs insulin glargine (95% CI) |
-8.5 (-9.7, -7.3)i |
-8.7 (-9.9, -7.5)i |
-10.5 (-11.7, -9.3)i |
-- |
SURPASS-5 |
n=116 |
n=118 |
n=118 |
n=119 |
Baseline |
112.2 |
111.9 |
111.3 |
109.9 |
Waist circumference CFB |
-3.8d |
-7.4d |
-8.9d |
1.0 |
Difference vs placebo (95% CI) |
-4.8 (-6.7, -2.9)c |
-8.4 (-10.3, -6.5)c |
-10.0 (-11.9, -8.1)c |
-- |
SURPASS-6 |
n=242 |
n=238 |
n=236 |
n=708 |
Baseline |
109.7 |
108.5 |
109.5 |
109.5 |
Waist circumference CFB |
-5.7 |
-7.8 |
-9.6 |
2.1 |
Difference vs insulin lispro (95% CI) |
-7.8 (-8.8, -6.8)j |
-9.9 (-10.9, -8.9)j |
-11.7 (-12.6, -10.7)j |
- |
Abbreviations: CFB = change from baseline; LSM = least squares mean; mITT = modified intention-to-treat.
aData are LSM, mITT population (efficacy analysis set).
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.
cp<.001 vs placebo.
dp<.001 vs baseline.
ep<0.05 vs semaglutide 1 mg.
fp<0.001 vs semaglutide 1 mg.
gp<.01.
hp<.001 vs insulin degludec.
ip<.001 vs insulin glargine.
jp<.001 vs insulin lispro
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.8
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
8Ludvik 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 21, 2023