Eli Lilly and Company has reported that its weight loss therapy, tirzepatide, met both co-primary objectives and all major secondary objectives in the Phase III SURMOUNT-2 trial.
The trial examined the efficacy and safety of tirzepatide for chronic weight management.
It assessed 938 adults with obesity or overweight and type 2 diabetes.
According to the company, the trial participants who received tirzepatide 15mg lost up to 15.7% of body weight for the efficacy estimand.
They also achieved average weight reductions of 13.4% when treated with tirzepatide 10mg as against a placebo.
Furthermore, 81.6% and 86.4% of the subjects who received tirzepatide achieved a minimum of 5% body weight loss, the other co-primary endpoint of the trial, in comparison with 30.5% of those taking a placebo.
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By GlobalDataThe trial’s secondary objectives included decrease in A1C and other cardiometabolic parameters.
Tirzepatide’s overall safety profile was found to be similar to previously announced SURMOUNT and SURPASS trials and to incretin-based therapies approved for obesity and overweight treatment.
The most common adverse events were gastrointestinal related and generally mild to moderate in severity, which typically happened during the dose-escalation period.
The trial’s overall treatment discontinuation rates were 9.3%, 13.8% and 14.9% for 10mg, 15mg and placebo, respectively.
Eli Lilly and Company product development senior vice-president Jeff Emmick said: “Obesity is a difficult-to-manage disease, and it’s even more difficult for people living with type 2 diabetes.
“The degree of mean weight reduction seen in SURMOUNT-2 has not been previously achieved in Phase III trials for obesity or overweight and type 2 diabetes.”