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INDIANAPOLIS, Dec. 9, 2020 /PRNewswire/ -- Tirzepatide led to superior A1C and body weight reductions from baseline in adults with type 2 diabetes after 40 weeks of treatment in topline results from Eli Lilly and Company's (NYSE: LLY) SURPASS-1 monotherapy clinical trial evaluating the efficacy and safety of tirzepatide compared to placebo. Using the efficacy estimandi, the highest dose of tirzepatide led to an A1C reduction of 2.07 percent and reduced body weight by 9.5 kg (11.0 percent). More than half (51.7 percent) of participants in this arm achieved an A1C less than 5.7 percent – the level seen in people without diabetes.
The overall safety profile of tirzepatide was similar to the well-established GLP-1 receptor agonist class, with gastrointestinal side effects being the most commonly reported adverse events. Treatment discontinuation rates due to adverse events were less than 7 percent in each tirzepatide treatment arm.
Tirzepatide is a novel investigational once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-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. The primary and key secondary endpoints of SURPASS-1, the first phase 3 trial of the comprehensive SURPASS program, included superior A1C and mean body weight reductions compared to placebo. Study participants, 54.2 percent of whom were treatment-naïve, had a relatively short mean duration of diabetes of 4.7 years, a baseline A1C of 7.9 percent and a baseline weight of 85.9 kg.
"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. "The study took a bold approach in assessing A1C targets. Not only did nearly 90 percent of all participants taking tirzepatide meet the standard A1C goal of less than 7 percent, more than half taking the highest dose also achieved an A1C less than 5.7 percent, the level seen in people without diabetes – an unprecedented finding and unique endpoint in trials evaluating glucose-lowering agents."
Treatment differences for two estimands – efficacy and treatment-regimenii – 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 (the American Diabetes Association's recommended target for people with diabetes) or less than 5.7 percent.
Efficacy Estimand Resultsiii | ||||
Tirzepatide 5 mg | Tirzepatide 10 mg | Tirzepatide 15 mg | Placebo | |
A1C reduction from baseline of 7.9% | -1.87% | -1.89% | -2.07% | +0.04% |
Placebo-adjusted A1C reduction | -1.91% | -1.93% | -2.11% | N/A |
Weight reduction from baseline of 85.9 kg | -7.0 kg (-7.9%) | -7.8 kg (-9.3%) | -9.5 kg (-11.0%) | -0.7 kg (-0.9%) |
Placebo-adjusted weight reduction | -6.3 kg | -7.1 kg | -8.8 kg | N/A |
Percent of participants achieving A1C
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