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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 incidence of nausea in adults with type 2 diabetes taking Mounjaro® (tirzepatide)?
Gastrointestinal adverse events, including nausea, were the most frequently reported adverse reactions in clinical trials with tirzepatide. Incidence decreased over time and was comparable to the GLP-1 receptor agonist class.
See important safety information, including boxed warning, in the attached prescribing information.
Nausea
Mounjaro (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
Reported gastrointestinal (GI) adverse events (AEs), including nausea, were the most frequently reported adverse reactions in clinical trials with tirzepatide. The majority of the reported GI AEs occurred during dose escalation and decreased over time.1
In pooled data derived from 2 placebo-controlled trials with a mean treatment duration of 36.6 weeks, nausea was reported in
- 18% of patients receiving tirzepatide 15 mg
- 15% of patients receiving tirzepatide 10 mg
- 12% of patients receiving tirzepatide 5 mg, and
- 4% of patients receiving placebo.1
Across 5 clinical studies, SURPASS-1, 2, 3, 4, and 5, the percent of patients experiencing nausea ranged between
- 18% to 24% for tirzepatide 15 mg
- 13% to 23% for tirzepatide 10 mg, and
- 12% to 17% for tirzepatide 5 mg.2-6
The study design for the SURPASS clinical trial program included a 20 week dose escalation phase. The starting dose of tirzepatide was 2.5 mg once weekly for 4 weeks, escalated in 2.5 mg increments every 4 weeks until the assigned dose of 5, 10, or 15 mg was achieved. 2-6
The slow dose escalation scheme used in the SURPASS clinical trial program was associated with a better GI AE profile than the rapid dose escalation scheme used in the phase 2 trial.3
The incidence of nausea with tirzepatide, which refers to the proportion of participants who experienced a new event during a specified time interval, decreased over time during clinical trials and was comparable to the GLP-1 receptor agonist class.1,7
The incidence of nausea over time in SURPASS-2, which compared tirzepatide with semaglutide 1 mg, is shown in Incidence of Nausea Over Time Through 40 Weeks in SURPASS-2.3
Figure 1 description: In SURPASS-2, tirzepatide 5 mg, 10 mg, and 15 mg, and semaglutide 1 mg each demonstrated similar rates of nausea during initiation but decreased over time.
Abbreviations: mITT = modified intention-to-treat; SEMA = semaglutide; TZP = tirzepatide.
Data are percent of participants who reported a new event relative to participants at risk during a time interval; mITT population (safety analysis set). Shaded areas indicate the period of time before reaching the maintenance dose of the study treatments. Incidence refers to the proportion of participants who have a new event during a time interval.
Use of Antiemetic Medication in SURPASS-1 to -5
The clinical trial protocols for SURPASS-1 to -5 provided information on the management of patients with GI symptoms. Among other options to mitigate GI symptoms and manage patients with intolerable GI AEs, the investigator was asked to
- advise patients to eat smaller meals and to stop eating when they feel full, and
- prescribe symptomatic medication (eg, antiemetic medication) per local country availability and individual patient needs.8
Use of symptomatic medication was captured as concomitant medication in the study record.8
In the SURPASS-1 to -5 trials, the proportion of tirzepatide-treated patients who received antiemetic medications during the course of the trial is shown in (Proportion of Patients Taking 1 or More Antiemetic Medication During the Study Treatment Period in SURPASS-1 to -5).8
Trial |
Tirzepatide 5 mg |
Tirzepatide 10 mg |
Tirzepatide 15 mg |
SURPASS-1 |
10/121 (8.3) |
9/121 (7.4) |
11/121 (9.1) |
SURPASS-2 |
67/470 (14.3) |
71/469 (15.1) |
101/470 (21.5) |
SURPASS-3 |
22/358 (6.1) |
36/360 (10.0) |
52/359 (14.5) |
SURPASS-4 |
33/329 (10.0) |
47/328 (14.3) |
63/338 (18.6) |
SURPASS-5 |
7/116 (6.0) |
13/119 (10.9) |
12/120 (10.0) |
Abbreviation: mITT = modified intention-to-treat.
Note: Data is n/N (%) from the mITT population (full analysis set), defined as the number of patients who were randomized and received at least 1 dose of study drug per the assigned treatment group.
n = number of patients in the assigned treatment group that reported taking ≥1 antiemetic medication during the study treatment period.
N = number of patients in the assigned treatment group who were randomized and received at least 1 dose of study drug.
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; 2025.
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
7Karagiannis T, Avgerinos I, Liakos A, et al. Management of type 2 diabetes with the dual GIP/GLP-1 receptor agonist tirzepatide: a systematic review and meta-analysis. Diabetologia. 2022;65(8):1251-1261. https://doi.org/10.1007/s00125-022-05715-4
8Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: June 08, 2023