ADA2021

#ADA2021 Latest data from SURPASS trials demonstrate tirzepatide provided meaningful blood sugar reductions and weight loss

Results from four clinical studies identify potential new treatment option for people with type 2 diabetes

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WASHINGTON, DC (JUNE 29, 2021) – Data from the SURPASS global clinical development program for Eli Lilly and Company’s tirzepatide, a novel investigational once-weekly medication for the treatment of type 2 diabetes, demonstrates statistically significant A1C and weight reductions versus several comparators. Findings of global registration trials, SURPASS-1, SURPASS-2, SURPASS-3, and SURPASS-5 were presented at the virtual 81st Scientific Sessions of the American Diabetes Association® (ADA). The SURPASS-1 study was be simultaneously published in The Lancet and SURPASS-2 was simultaneously published in The New England Journal of Medicine.

For patients with diabetes, high blood glucose levels and being overweight translates to greater risk of developing complications. Blood glucose levels over the past two to three months can be measured with a test called A1C. With more than 34 million Americans living with diabetes1 and 78% of people with diabetes considered to have obesity,2 there is an ongoing need for solutions to help patients manage weight and meet their full treatment needs.

Tirzepatide is a novel, once-weekly injectable dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that integrates the actions of the GIP and GLP-1 incretins into a single molecule, representing a new class of medicines for the treatment of type 2 diabetes. Tirzepatide is under development and in phase three of clinical trials for the treatment of type 2 diabetes.

Each SURPASS trial was designed to provide insights into tirzepatide’s potential as a treatment for type 2 diabetes. SURPASS-1 evaluated the efficacy and safety of three tirzepatide doses (5 mg, 10 mg, and 15 mg) as monotherapy against placebo among people with type 2 diabetes. SURPASS-2 and SURPASS-3 compared the efficacy and

1 https://www.cdc.gov/diabetes/data/statistics- report/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fdiabetes%2Fdata%2Fstatistics%2Fstatistics- report.html

2 https://www.tandfonline.com/doi/full/10.1185/03007995.2016.1168291

 

safety of the same three doses of tirzepatide to injectable semaglutide 1 mg and insulin degludec, respectively. SURPASS-5 evaluated the efficacy and safety of tirzepatide as an add-on to insulin glargine compared to placebo.

 

In each study, tirzepatide achieved its primary and key secondary endpoints for the efficacy estimand and delivered consistent safety and efficacy with sustained A1C reduction and progressive weight loss among people with type 2 diabetes:

  • In SURPASS-1, all three tirzepatide doses demonstrated statistically significant and clinically meaningful improvements in A1C and body weight reductions compared to placebo. Up to 92% of participants on tirzepatide achieved an A1C of less than 7%—the ADA’s recommended target for most people with diabetes. Up to 52% achieved an A1C of less than 7%—the level for people without diabetes.
  • In SURPASS-2, all three tirzepatide doses delivered superior A1C and body weight reductions from baseline compared to semaglutide. Up to 92% of participants on tirzepatide achieved an A1C of less than 7% and up to 51% achieved an A1C less than 5.7%.
  • In SURPASS-3, all three tirzepatide doses delivered superior A1C and body weight reductions from baseline compared to titrated insulin Up to 93% of participants on tirzepatide achieved an A1C of less than 7% and up to 48% achieved an A1C of less than 5.7%.
  • In SURPASS-5, all three tirzepatide doses delivered superior A1C reductions and weight reductions compared to placebo both added to titrated insulin glargine. Up to 97% of participants on tirzepatide achieved an A1C of less than 7% and up to 62% of participants on tirzepatide achieved an A1C of less than 5.7%.

 

“Collectively, the SURPASS study results exceeded our expectations and point toward tirzepatide’s efficacy in people living with type 2 diabetes at different stages of their treatment journeys,” said Laura Fernández Landó, M.D., Senior Medical Director of tirzepatide for type 2 diabetes at Eli Lilly and Company. “Tirzepatide is delivering unprecedented results that could help millions of people with type 2 diabetes and their health care providers reach A1C and weight goals—both key measures of diabetes management.”

The studies presented at the ADA’s 81st Scientific Sessions are part of the SURPASS global clinical development program, which has enrolled more than 19,000 people with type 2 diabetes across ten clinical trials, five of which are global registration studies.

Research presentation details:

  • Study investigators presented the findings of the SURPASS trial during the sessions listed below (all sessions will be recorded and accessible for 90 days):

 

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