SURMOUNT-2 evaluated the efficacy and safety of tirzepatide for chronic weight management in 938 adults with obesity or overweight and type 2 diabetes
Tirzepatide is a once-weekly GIP and GLP-1 receptor agonist. (Credit: Lilly USA, LLC.)
Eli Lilly and Company (Lilly) has announced that tirzepatide (10mg and 15mg) has shown superior weight loss compared to placebo at 72 weeks of treatment of adults with obesity or overweight and type 2 diabetes in the phase 3 SURMOUNT-2 trial.
Tirzepatide is a glucose-dependent insulinotropic polypeptide (GIP) receptor and GLP-1 (glucagon-like peptide-1) receptor agonist that is dosed once a week.
The SURMOUNT-2 study met both co-primary objectives and all key secondary objectives for the GIP receptor, compared to placebo for both estimands.
According to the results, patients taking the GIP receptor lost up to 15.7% of body weight for the efficacy estimand.
SURMOUNT-2 is a global multi-centre, randomised, double-blind, parallel, placebo-controlled trial. It evaluated the efficacy and safety of tirzepatide for chronic weight management in 938 obese type 2 diabetics adults.
Lilly product development SVP 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 3 trials for obesity or overweight and type 2 diabetes.”
For the efficacy estimand, patients dosed with tirzepatide showed an average weight reduction of 13.4% on 10mg and 15.7% on 15mg, compared to placebo.
Furthermore, 81.6% (10mg) and 86.4% (15mg) of people taking the GIP receptor achieved at least 5% body weight reduction, which is the other co-primary endpoint, compared to 30.5% of those subjected to placebo.
Additionally, the GIP receptor met all key secondary objectives, which included a reduction in A1C and other cardiometabolic parameters.
Lilly said that 41.4% (10mg) and 51.8% (15mg) of participants taking the GIP receptor demonstrated at least 15% body weight reduction, compared to 2.6% of those treated with placebo.
The pharma major stated that the overall safety profile of tirzepatide was identical to reports from the SURMOUNT and SURPASS trials and to approved incretin-based therapies for obesity and overweight.
Lilly said that it will continue evaluating the SURMOUNT-2 results to complete the US submission for the GIP receptor with regulatory action expected as early as late 2023.
Tirzepatide was approved under the brand name Mounjaro by the US Food and Drug Administration (FDA) in May 2022.