Data presented at ADA's 81st Scientific Sessions® show the highest dose of tirzepatide (15 mg) reduced A1C by 2.07 percent and weight by 9.5 kg (20.9 lb., 11.0 percent)

Majority of study population was treatment-naïve; lowest dose of tirzepatide (5 mg) led to A1C and body weight reductions of 1.87 percent and 7.0 kg (15.4 lb., 7.9 percent)

INDIANAPOLIS, June 26, 2021 /PRNewswire/ -- Tirzepatide led to superior A1C and body weight reductions from baseline across all three doses in adults with type 2 diabetes after 40 weeks of treatment in Eli Lilly and Company's (NYSE: LLY) SURPASS-1 monotherapy clinical trial evaluating the efficacy and safety of tirzepatide compared to placebo. Detailed SURPASS-1 results were presented today in an oral presentation during the American Diabetes Association's® (ADA) 81st Scientific Sessions®, were simultaneously published in The Lancet and will be featured during an ADA-sponsored symposium on Tuesday, June 29.

Study participants in SURPASS-1, 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. For the efficacy estimandi, tirzepatide reduced A1C by up to 2.07 percent and body weight by up to 9.5 kg (20.9 lb., 11.0 percent) compared to placebo (+0.04 A1C change and body weight change of -0.7 kg [1.5 lb., 0.9 percent]). Up to 52 percent of participants achieved an A1C less than 5.7 percent – the level seen in people without diabetes. Tirzepatide also led to improvements in the change in fasting serum glucose from baseline. In an additional secondary endpoint, tirzepatide led to improvements in the change in two-hour post-meal glucose values from baseline from self-monitored blood glucose data.1,2

The overall safety profile of tirzepatide was similar to the well-established glucagon-like peptide-1 (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.1

"Type 2 diabetes is a progressive disease, and many people with the condition have trouble reaching their A1C goals through diet and exercise. This monotherapy clinical trial was designed to assess the impact of tirzepatide alone on several important diabetes treatment targets, including glycemic control and weight loss," said Julio Rosenstock, M.D., Director of the Dallas Diabetes Research Center at Medical City and Principal Investigator of SURPASS-1. "In the SURPASS-1 results, tirzepatide led to significant improvements across all primary and key secondary endpoints with clinically meaningful A1C reductions and robust weight loss among study participants, who had a relatively short duration of type 2 diabetes."

Tirzepatide is a novel investigational once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptor agonist that integrates the actions of the GIP and GLP-1 incretins into a single molecule, representing a new class of medicines being studied for the treatment of type 2 diabetes.

For both estimandsii, 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.1

At 40 weeks, tirzepatide led to a significant decrease in fasting serum glucose (FSG) compared to placebo. In an additional secondary endpoint, the mean two-hour post-meal glucose values for tirzepatide across all three doses were under 140 mg/dL (considered normal values in individuals without diabetes).2

Specifically, the efficacy estimand results showed:

• A1C change: -1.87% (5 mg), -1.89% (10 mg), -2.07% (15 mg), +0.04% (placebo)
• Weight reduction: -7.0 kg (-7.9%, 5 mg), -7.8 kg (-9.3%, 10 mg), -9.5 kg (-11.0%, 15 mg), -0.7 kg (-0.9%, placebo)
• Percent of participants achieving A1C