Eli Lilly’s investigational candidate tirzepatide achieved superior A1C and body weight reductions compared with insulin glargine in adults with type 2 diabetes who have increased cardiovascular risk.
Tirzepatide is a once-weekly investigational dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist.
Preclinical studies have shown that GIP decreases food intake while increasing energy expenditure to result in weight reductions.
When combined with a GLP-1 receptor agonist, this may lead to greater effects on glucose and body weight, according to Lilly.
The SURPASS-4 trial is Lilly’s fifth and final global registration study for tirzepatide in type 2 diabetes, comparing the safety and efficacy of three doses of tirzepatide to titrated insulin glargine in over 2,000 people with type 2 diabetes who have increased CV risk.
The trial achieved all of its primary and key secondary doses, with all three doses of tirzepatide – 5mg, 10mg and 15mg – leading to superior A1C and body weight reductions compared to insulin glargine.
Of the patients receiving the highest tirzepatide dose, 91% achieved an Q1C less than 7%, the recommended target for people with diabetes, and 43% achieved an A1C less than 5.7%, the level seen in people without diabetes.
In this study, the most common adverse events in the tirzepatide arms at 52 weeks were gastrointestinal-related and generally mild-to-moderate in severity.
"These strong results reinforce our belief that tirzepatide has the potential to be an exciting treatment for people living with type 2 diabetes," said Mike Mason, president, Lilly Diabetes.
"We look forward to meeting our goal of bringing an important new therapy to people living with this condition, including sharing more detailed results at scientific congresses and submitting to regulatory authorities later this year,” he added.