Eli Lilly’s diabetes drug tirzepatide reduces blood glucose and weight in Phase III trials
pharmafile | February 18, 2021 | News story | | Eli Lilly, diabetes
Eli Lilly’s tirzepatide led to significant haemoglobin A1C (HbA1C) and body weight reductions from baseline in adults with type 2 diabetes in the SURPASS-3 and SURPASS-5 Phase III clinical trials, after 52 weeks and 40 weeks, respectively.
Tirzepatide is a novel investigational once-weekly, dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 (GLP-1) receptor agonist that integrates the actions of both incretins into a single molecule, representing a new class of medicines being studied for the treatment of type 2 diabetes.
In top-line results, the primary and all key secondary endpoints were met for both efficacy and treatment-regimen estimands in SURPASS-3, which compared tirzepatide with titrated insulin degludec, and in SURPASS-5, which compared tirzepatide with a placebo, both as an add-on to titrated insulin glargine.
The highest dose of tirzepatide reduced HbA1C by 2.37% and body weight by 12.9kg in SURPASS-3, and reduced HbA1C by 2.59% and body weight by 10.9kg in SURPASS-5. At the highest dose, 62.4% of SURPASS-5 participants – who had a mean duration of diabetes of 13.3 years – achieved an HbA1C of less than 5.7%, the level seen in people without diabetes.
In both studies, the overall safety profile of the drug similar to that of the well-established GLP-1 receptor agonist class, with gastrointestinal side effects being the most commonly reported adverse events and decreasing with continued dosing.
Mike Mason, President of Lilly Diabetes, said: “Tirzepatide delivered impressive HbA1C and body weight reductions in both studies and continued to achieve consistent efficacy and safety results in people living with type 2 diabetes, regardless of how long they have had the condition.
“Significantly lowering HbA1C levels and weight are high priorities throughout the type 2 diabetes treatment journey, and the results we have seen from three SURPASS studies to date fuel our belief in tirzepatide’s ability to meet those needs.”
Darcy Jimenez
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