Eli Lilly and Co.’s (LLY) tirzepatide significantly reduced A1C and body weight in people with type 2 diabetes, after 40 weeks of treatment, as per the company’s SURPASS-1 monotherapy clinical trial. The trial evaluated the efficacy and safety of tirzepatide compared to placebo.
As per the study results, more than half of participants taking the highest dose of tirzepatide achieved normal A1C levels, a key secondary endpoint in first phase 3 trial of SURPASS program.
Treatment discontinuation rates due to adverse events were less than 7 percent in each tirzepatide treatment arm.
“Tirzepatide delivered impressive A1C and weight reductions for people with type 2 diabetes in this trial, confirming and building upon the phase 2 data that were released in 2018,” said Julio Rosenstock, M.D., Director of the Dallas Diabetes Research Center and Principal Investigator of SURPASS-1.
Tirzepatide is a novel investigational once-weekly dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-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.
Treatment differences for two estimands – efficacy and treatment-regimen – were evaluated for the three tirzepatide doses (5 mg, 10 mg and 15 mg) compared to placebo.
Across both estimands, all three tirzepatide doses reached statistical significance in A1C and body weight reductions from baseline and in the percentage of participants who achieved an A1C of less than 7 percent or less than 5.7 percent.
The company noted that the complete SURPASS-1 study data have not yet been evaluated but will be presented at the American Diabetes Association’s 81st Scientific Sessions and published in a peer-reviewed publication in 2021. SURPASS-1 is the first phase 3 trial of the comprehensive SURPASS program.
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