Over Half of Patients Achieve Normal A1C Levels with Lilly's GIP/GLP-1 Dual Agonist Tirzepatide in Positive Phase 3 Trial

Eli Lilly and Company today announced that tirzepatide, its dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist, achieved positive top-line results in the Phase 3 SURPASS-1 clinical trial. After 40 weeks of treatment, tirzepatide significantly reduced glycated hemoglobin (A1C) levels and body weight in adult patients with type 2 diabetes compared with placebo.

Tirzepatide is a once-weekly injectable dual agonist of the GIP and GLP-1 receptors, integrating the effects of two incretin hormones into a single molecule, representing a novel therapeutic approach for type 2 diabetes. GIP is a hormone that may complement the actions of GLP-1 receptor agonists. In preclinical models, GIP has been shown to reduce food intake and increase energy expenditure, thereby leading to weight loss; when used in combination with GLP-1 receptor agonists, it may exert greater effects on glucose levels and body weight.

Among patients enrolled in the SURPASS-1 clinical trial, 54.2% were treatment-naïve, with a relatively short mean duration of diabetes (4.7 years), a baseline A1C level of 7.9%, and a baseline body weight of 85.9 kg.

The SURPASS-1 clinical trial evaluated the efficacy and safety of three different doses (5 mg, 10 mg, and 15 mg) of tirzepatide. The results demonstrated that all doses of tirzepatide reduced patients’ HbA1c levels and body weight compared to baseline. The highest dose of tirzepatide lowered HbA1c by 2.07% and reduced body weight by 9.5 kg (11.0%). In this group, 51.7% of patients achieved an HbA1c level below 5.7%, a level observed in individuals without diabetes.

▲Efficacy Data of Tirzepatide (Image source: Reference [1])

“Tirzepatide brought significant reductions in A1C levels and body weight to patients with type 2 diabetes in this trial,” said Dr. Julio Rosenstock, principal investigator of SURPASS-1 and director of the Dallas Diabetes Research Center. “The study boldly adopted the unique endpoint of assessing A1C levels. Among all participants receiving tirzepatide, nearly 90% achieved an A1C level below 7%, the target recommended by the American Diabetes Association for patients with diabetes. Moreover, among those receiving the highest dose, more than half achieved an A1C level below 5.7%, which is within the range observed in individuals without diabetes.”

▲ Clinical Development Program of Tirzepatide for Type 2 Diabetes (Image source: Eli Lilly and Company official website)

Tirzepatide is one of Eli Lilly and Company’s key research and development projects in the field of diabetes. The company’s SURPASS clinical development program comprises multiple clinical trials designed not only to evaluate the efficacy and safety of tirzepatide as monotherapy, but also to compare its efficacy with other therapies for type 2 diabetes. Eli Lilly and Company expects to submit regulatory applications globally in 2022.

References:

[1] Lilly's tirzepatide significantly reduced A1C and body weight in people with type 2 diabetes. Retrieved December 9, 2020, from https://investor.lilly.com/news-releases/news-release-details/lillys-tirzepatide-significantly-reduced-a1c-and-body-weight

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