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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 were the Mounjaro® (tirzepatide) discontinuation rates in the SURPASS clinical trial program?
In the SURPASS-1 to -6 trials in adults with T2D, overall treatment discontinuation rates ranged from 7.8% to 21.5% and the rate of adverse events leading to study drug discontinuation ranged from 3.3% to 10.9% in the tirzepatide treatment arms.
See important safety information, including boxed warning, in the attached prescribing information.
Study Drug Discontinuation in the SURPASS Clinical Trial Program
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
The efficacy and safety of tirzepatide were evaluated in people with T2D in the SURPASS clinical trial program.2-7
Among all randomized adults with type 2 diabetes in SURPASS-1 to -6, the overall treatment discontinuation rates ranged from 7.8% to 21.5% in the tirzepatide treatment arms. In these patients, adverse events were the most common reason for discontinuation of treatment.2-7
Rates of study drug discontinuation and of study drug discontinuation due to adverse event by treatment arm in SURPASS-1 to -6 are described in Summary of Study Drug Discontinuation in the SURPASS-1 to -6 Studies.2,3,5-8
Parametera |
Tirzepatide 5 mg |
Tirzepatide 10 mg |
Tirzepatide 15 mg |
Comparatorb |
Study drug discontinuation |
||||
SURPASS-1 |
11/121 (9.1) |
12/121 (9.9) |
26/121 (21.5) |
17/115 (14.8) |
SURPASS-2 |
39/471 (8.3) |
58/469 (12.4) |
62/470 (13.2) |
41/469 (8.7) |
SURPASS-3 |
42/359 (11.7) |
66/361 (18.3) |
59/359 (16.4) |
40/365 (11.0) |
SURPASS-4 |
51/329 (15.5) |
44/330 (13.3) |
55/338 (16.3) |
139/1005 (13.8) |
SURPASS-5 |
11/116 (9.5) |
14/119 (11.8) |
22/120 (18.3) |
4/120 (3.3) |
SURPASS-6 |
19/243 (7.8) |
20/238 (8.4) |
30/236 (12.7) |
88/711 (12.4) |
Study drug discontinuation due to adverse eventc |
||||
SURPASS-1 |
4/121 (3.3) |
6/121 (5.0) |
8/121 (6.6) |
2/115 (1.7) |
SURPASS-2 |
24/471 (5.1) |
36/469 (7.7) |
37/470 (7.9) |
18/469 (3.8) |
SURPASS-3 |
26/359 (7.2) |
35/361 (9.7) |
39/359 (10.9) |
5/365 (1.4) |
SURPASS-4 |
24/329 (7.3) |
26/330 (7.9) |
30/338 (8.9) |
19/1005 (1.9) |
SURPASS-5 |
7/116 (6.0) |
10/119 (8.4) |
13/120 (10.8) |
3/120 (2.5) |
SURPASS-6 |
8/243 (3.3) |
10/238 (4.2) |
21/236 (8.9) |
6/711 (0.8) |
Note: Primary endpoint for SURPASS-1, SURPASS-2, and SURPASS-5 was at 40 weeks and for SURPASS-3, SURPASS-4, and SURPASS-6 was at 52 weeks.
aData are n/N (%); N = all randomized population.
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 three times daily in SURPASS-6 for 52 weeks.
cReported data does not include study drug discontinuation due to death.
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
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
9Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: October 05, 2023