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★ Mounjaro demonstrated superior mean HbA1c Reductions with with every dose, outperforming comparators in all phase 3 studies

Efficacy Chart

References

1- Rosenstock J, et.al, Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. Lancet. 2021;398(10295):143-155.9.

2- Frías 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):503-515.10.

3- Ludvik B, 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):583-598.11.

4- Del Prato S, et al. Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial. The Lancet. 2021 Nov 13;398(10313):1811-24.12.

5- Dahl D, 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.

SURPASS Studies

Mounjaro vs. Placebo
(T2D patients who had inadequate glycemic control with diet and exercise)

Surpass 1 Trial Design
★ SURPASS-1 Trial Design

  • SURPASS-1 was a 40-week, double-blind, placebo-controlled, phase 3 trial that randomized 478 adult patients with T2D who had inadequate glycemic control with diet and exercise to receive once-weekly SC Mounjaro 5 mg, 10 mg, or 15mg, or placebo (1:1:1:1 ratio).

  • Study participants had a mean baseline A1C of 7.9% and mean T2D duration of 4.7 years.

PRIMARY ENDPOINTS

  • Superiority of Mounjaro 5 mg, 10 mg, and/or 15mg to placebo in mean change from baseline in A1C at 40 weeks.

KEY SECONDARY ENDPOINTS

  • Mean change from baseline in fasting serum glucose to week 40.

  • The proportion of participants with HbA1c target values of less than 7∙0% (<53 mmol/mol) and less than 5∙7% (<3 mmol/mol)

  • Mean change from baseline in bodyweight.

★ Mounjaro demonstrated SUPERIORITY in HbA1c reduction vs. placebo

PRIMARY ENDPOINTS

  • Mean Change in HbA1c from baseline to week 40

Mean Change in HbA1c from baseline to week 40

Mean Change in HbA1c
Up to 2.07%

Significant Reductions

in HbA1c with Mounjaro 15mg at 40 weeks

p<0.0001 vs placebo HbA1c values over time from MMRM analysis. Data are LSM (SE), unless otherwise noted. Estimated treatment differences are LSM (95% CI) at 40 weeks, modified intention-to-treat population (efficacy analysis set). Arrows indicate when the maintenance dose of tirzepatide 5, 10, and 15 mg was reached.

★ Mounjaro demonstrated SUPERIORITY in HbA1c reduction vs. placebo

PRIMARY ENDPOINTS

- Mean Change in HbA1c from baseline to week 40

Mean Change in HbA1c from baseline to week 40

Mean Change in HbA1c
Up to 2.07%
Significant Reductions

in HbA1c with Mounjaro at 40 weeks

p<0.0001 vs placebo HbA1c values over time from MMRM analysis. Data are LSM (SE), unless otherwise noted. Estimated treatment differences are LSM (95% CI) at 40 weeks, modified intention-to-treat population (efficacy analysis set). Arrows indicate when the maintenance dose of tirzepatide 5, 10, and 15 mg was reached.

★ A significantly higher proportion of participants given Mounjaro reached HbA1c targets (<7·0%, ≤6·5%, and <5·7%)

Percentage of participants reaching HbA1c targets (<7·0%, ≤6·5%, and <5·7%)

Percentage of participants reaching HbA1c targets
p<0.0001 vs placebo Change from baseline in HbA1c at 40 weeks from MMRM analysis... Data are LSM (SE), unless otherwise noted. Estimated treatment differences are LSM (95% CI) at 40 weeks, modified intention-to-treat population (efficacy analysis set).

★ Significant Weight Reductions with Mounjaro vs. Placebo

Change from baseline in Bodyweight at 40 weeks

Change from baseline in Bodyweight
11%
Significant Reductions

in bodyweight with Mounjaro 15mg at 40 weeks

p<0.0001 vs placebo Change from baseline in bodyweight at 40 weeks from MMRM analysis. Data are LSM (SE), unless otherwise noted. Estimated treatment differences are LSM (95% CI) at 40 weeks, modified intention-to-treat population (efficacy analysis set).

★ A significantly higher proportion of participants given Mounjaro reached weight loss aims (≤5%, ≤10%, and ≤15%)

Percentage of people who achieved ≥5%, ≥10% and ≥15% Weight Reductions at 40 weeks

Percentage of people who achieved Weight Reductions
p<0.0001 vs placebo Proportion of participants reaching weight loss aims (≤5%, ≤10%, and ≤15%) was obtained by dividing the number of patients reaching respective goals at week 40 by the number of patients with baseline value and at least one non-missing post-baseline value. Missing value at week 40 was predicted from MMRM analysis. Data are LSM (SE), unless otherwise noted. Estimated treatment differences are LSM (95% CI) at 40 weeks, modified intention-to-treat population (efficacy analysis set).

References

Rosenstock J, et.al, Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. Lancet. 2021;398(10295):143-155.