Eli Lilly and Company has reported that the SURPASS-4 clinical trial of its investigational treatment, tirzepatide, in type 2 diabetes patients with greater cardiovascular (CV) risk met all the primary and key secondary endpoints.
An agonist of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor, tirzepatide combines the activities of the GIP and GLP-1 incretins into one molecule.
The global, open-label, randomised, parallel SURPASS-4 trial compared the safety and efficacy of 5mg, 10mg and 15mg doses of tirzepatide to titrated insulin glargine in 2,002 subjects for 52 weeks.
These subjects also received one to three oral antihyperglycemic medicines such as metformin.
The non-inferiority of a 10mg and/or 15mg tirzepatide to insulin glargine for change from baseline glycated haemoglobin (A1C) in the participants at 52 weeks formed the primary goal of the trial.
Top-line data from the trial showed that all three tested doses of the investigational treatment offered reductions in A1C and body weight from baseline versus titrated insulin glargine in the trial subjects.
In the efficacy analysis, the highest dose of tirzepatide was found to provide an A1C reduction of 2.58% and reduced body weight by 11.7kg versus 1.44% A1C reduction and weight gain of 1.9kg in the insulin glargine arm at 52 weeks.
Tirzepatide’s overall safety profile was in line with the GLP-1 receptor agonist class in these subjects.
The most reported adverse events were gastrointestinal side effects, which commonly arose during the escalation period and subsided over time.
Eli Lilly Diabetes president Mike Mason said: “These strong results reinforce our belief that tirzepatide has the potential to be an exciting treatment for people living with type 2 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.”
The company noted that as the SURPASS programme met regulatory submission needs for assessing CV risk, it plans to submit the full registration data to regulatory authorities by the year-end.
Last month, Lilly reported that first-time data from the Phase I/II LIBRETTO-001 trial of Retevmo treatment showed promising antitumour activity and safety in various RET fusion-positive advanced solid tumours.