Eli Lilly and Company has reported that its experimental therapy, tirzepatide, demonstrated reductions in A1C and body weight in a Phase III SURPASS-4 clinical trial of type 2 diabetes patients with high cardiovascular (CV) risk.
Tirzepatide is a dual agonist of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor.
The international, randomised, open-label, parallel Phase III trial assessed the efficacy and safety of 5mg, 10mg and 15mg doses of tirzepatide against insulin glargine in 2,002 adult subjects.
These patients included people with type 2 diabetes ineffectively controlled with a minimum of one and up to three oral antihyperglycemic treatments and have high CV risk.
The trial recruited subjects in the European Union, North America, Australia, Israel, Taiwan and Latin America and categorised them into a 1:1:1:3 ratio to give either 5mg / 10mg / 15mg tirzepatide or insulin glargine.
Establishing the non-inferiority of 10mg and/or 15mg tirzepatide to insulin glargine for change from baseline A1C at 52 weeks was the primary aim of the trial.
The highest dose of tirzepatide showed a 2.58% decline in A1C and reduced body weight by 11.7kg versus subjects receiving insulin glargine for the efficacy estimand.
The overall safety profile of tirzepatide was in line with the safety results measured at 52 weeks, with no new findings reported up to 104 weeks.
The most common adverse events observed were gastrointestinal, which happened during the escalation period and then subsided over time.
The trial also met the primary and crucial secondary endpoints with all three doses of tirzepatide offering a statistically significant and higher decline in A1C and body weight versus insulin glargine at 52 weeks.
Furthermore, at 52 weeks, all three tested doses of tirzepatide provided favourable changes from baseline in fasting lipids.
Eli Lilly Product Development vice-president Jeff Emmick said: “Given the progressive nature of type 2 diabetes, evaluating the positive efficacy results we have seen with tirzepatide over longer periods of time is important.
“Throughout the length of SURPASS-4, tirzepatide delivered robust improvements in blood glucose levels, significant weight loss and consistent safety results in adults with type 2 diabetes and increased cardiovascular risk.”