See important safety information, including boxed warning, in the attached prescribing information.

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

The SURPASS clinical trial program assessed the efficacy and safety of tirzepatide as a treatment to improve glycemic control in people with T2D. Global registration trials include 5 registered clinical trials which compared tirzepatide with placebo, semaglutide, insulin degludec, and insulin glargine.2-6 SURPASS-6 compared tirzepatide with 3-times daily insulin lispro, both as add-on therapy in patients inadequately controlled with basal insulin.7

In patients with T2D, tirzepatide 5, 10, and 15 mg demonstrated

• superior glycated hemoglobin (HbA1c) reduction from baseline versus comparator (Summary of HbA1c in SURPASS Studies), and
• clinically meaningful and statistically significant proportion of participants achieving HbA1c goals of <7%, ≤6.5%, and <5.7% versus comparators (Proportion of Participants Achieving HbA1c Targets 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 without confounding effects of antihyperglycemic rescue therapy. Treatment-regimen estimand evaluates the treatment effect irrespective of adherence to the study drug or initiation of rescue antidiabetic drugs. 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.2-7 

In pooled data from SURPASS-1 to -4, participants with FSG reductions ≥10% or ≥20% after 4 weeks of tirzepatide treatment exhibited greater changes from baseline in HbA1c at week 40 compared to participants with FSG reductions of <10% or <20% by week 4.9 

In addition, greater early FSG reduction also corresponded to a greater proportion of these participants achieving HbA1c <7% by week 40.9

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.11

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

MOUNJARO® (tirzepatide) injection, for subcutaneous use, Lilly

The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).