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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 are the long-term efficacy results of Mounjaro® (tirzepatide) in adults with type 2 diabetes?
In adults with type 2 diabetes treated with tirzepatide, sustained reductions in HbA1c and weight continued through the primary treatment period to 104 weeks.
See important safety information, including boxed warning, in the attached prescribing information.
Tirzepatide Long-term Efficacy
The efficacy of tirzepatide in adults with type 2 diabetes (T2D) was evaluated in the SURPASS clinical trial program. Currently, the SURPASS-4 study provides the longest available efficacy data.
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.1
All participants were treated for at least 52 weeks, and treatment was to continue until
- 104 weeks, or
- study completion.1
Study completion was determined by the number of participants experiencing cardiovascular events. Safety measures were assessed over the full study period.1
In tirzepatide-treated patients, reductions in glycated hemoglobin (HbA1c)
- continued through the primary endpoint at 52 weeks, and
- were sustained after 78 and 88 weeks of treatment.1
Sustained reductions in HbA1c continued after 104 weeks of treatment were consistent, but the sample size was smaller. This study provides initial support for sustained glycemic control for more than 1 year with tirzepatide treatment.1
At 104 weeks, treatment with tirzepatide 5, 10, and 15 mg once weekly resulted in a sustained reduction in HbA1c and body weight (see Summary of Efficacy Outcomes at 104 Weeks From the SURPASS-4 Study).1
Parametera |
TZP 5 mg |
TZP 10 mg |
TZP 15 mg |
Insulin Glargineb |
Mean HbA1c at 104 weeks, % |
6.4 |
6.1 |
6.1 |
7.5 |
Mean HbA1c CFB at 104 weeks, % (baseline HbA1c 8.53%) |
-2.2 |
-2.5 |
-2.6 |
-1.1 |
Mean FSG CFB at 104 weeks, mg/dL (baseline 171.4 mg/dL) |
119.0 |
113.7 |
119.9 |
129.1 |
Mean weight at 104 weeks, kg |
83.6 |
80.8 |
79.2 |
92.9 |
Mean weight CFB at 104 weeks, kg (baseline 90.3 kg) |
-5.8 |
-10.4 |
-11.1 |
2.3 |
Abbreviations: CFB = change from baseline; FSG = fasting serum glucose; HbA1c = glycated hemoglobin; LSM = least squares mean; mITT = modified intention-to-treat; TZP = tirzepatide.
aData are LSM unless otherwise noted, mITT population (efficacy analysis set) N = participants in each arm at 104 weeks.
bThe starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a fasting blood glucose <100 mg/dL, following a treat-to-target algorithm. The mean insulin glargine dose was 47.0 IU at week 104.
The profile of HbA1c level over time with tirzepatide treatment indicated a sustained reduction up to 104 weeks, with nonmissing baseline HbA1c and 78-week data for 1166 (58%) participants and 104-week data for 199 (10%) participants (see Mean HbA1c Over Time in SURPASS-4 ).1
Figure 1 description: In SURPASS-4, tirzepatide demonstrated superiority and sustainability in the reduction of HbA1c when compared with insulin glargine added to at least 1 and up to 3 oral antihyperglycemic medications (metformin, sulfonylureas, or sodium-glucose cotransporter-2 inhibitors) in adults with type 2 diabetes up to 104 weeks.
Abbreviations: HbA1c = glycated hemoglobin; LSM = least squares mean; mITT population = modified intention-to-treat; MMRM = mixed-effects model for repeated measures; TZP = tirzepatide.
Note: mITT population (efficacy analysis set). Data are LSM (SE) over time, MMRM analysis up to 104 weeks. Arrows indicate time of primary endpoint. Dashed lines show baseline values and dotted lines show target values.
In SURPASS-4, reductions in fasting serum glucose were similar between tirzepatide and insulin glargine and were sustained over the duration of the study (see Mean Fasting Serum Glucose Over Time in SURPASS-4 ).1
Figure 2 description: In SURPASS-4, reductions in fasting serum glucose levels were similar between tirzepatide and insulin glargine added to at least 1 and up to 3 oral antihyperglycemic medications (metformin, sulfonylureas, or sodium-glucose cotransporter-2 inhibitors) and were sustained up to 104 weeks in adults with type 2 diabetes.
Abbreviations: FSG = fasting serum glucose; LSM = least squares mean; mITT population = modified intention-to-treat; MMRM = mixed-effects model for repeated measures; TZP = tirzepatide.
Note: mITT population (efficacy analysis set). Data are LSM (SE) over time, MMRM analysis up to 104 weeks. Arrows indicate time of primary endpoint. Dashed lines show baseline values and dotted lines show target values.
The reductions from baseline in weight for tirzepatide 5, 10, and 15 mg remained similar from 52 through 104 weeks (see Mean Body Weight Over Time in SURPASS-4 ).1
Figure 3 description: In SURPASS-4, tirzepatide demonstrated superiority and sustainability in body weight loss when compared with insulin glargine added to at least 1 and up to 3 oral antihyperglycemic medications (metformin, sulfonylureas, or sodium-glucose cotransporter-2 inhibitors) in adults with type 2 diabetes up to 104 weeks.
Abbreviations: BMI = body mass index; LSM = least squares mean; mITT = modified intention-to-treat; MMRM = mixed-effects model for repeated measures; TZP = tirzepatide.
Note: mITT population (efficacy analysis set). Data are LSM (SE) over time, MMRM analysis up to 104 weeks. Arrow indicates time of primary endpoint. Dashed line shows baseline value.
Enclosed Prescribing Information
References
The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).
1Del 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
Date of Last Review: August 26, 2024