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Indianapolis, June 26, 2021 /PRNewswire/——In Eli Lilly and Company (New York Stock Exchange stock code: NYSE:Lily) The clinical trial of SURPASS-1 monotherapy evaluates the efficacy and safety of tirzepatide compared with placebo.The detailed SURPASS-1 results were announced today in the oral report of the American Diabetes Association® (ADA) 81Yingshi Scientific conference®, Also published in Lancet And will be sponsored by ADA Tuesday, June 29.
Of the SURPASS-1 study participants, 54.2% of them had not received treatment, the average duration of diabetes was relatively short, 4.7 years, the baseline A1C was 7.9%, and the baseline weight was 85.9 kg.Estimation of efficacyI, Compared with placebo, tirzepatide reduced A1C by 2.07% and weight loss by 9.5 kg (20.9 pounds, 11.0%) (+0.04 A1C change and -0.7 kg weight change) [1.5 lb., 0.9 percent]). As many as 52% of the participants had A1C below 5.7%—a level seen in people without diabetes. Tirzepatide also resulted in an improvement in fasting blood glucose from baseline. In another secondary endpoint, tirzepatide resulted in an improvement in blood glucose values two hours after a meal relative to the baseline changes in self-monitored blood glucose data.1,2
The overall safety of tirzepatide is similar to that of recognized glucagon-like peptide-1 (GLP-1) receptor agonists, and gastrointestinal side effects are the most frequently reported adverse event. In each tirzepatide treatment group, the rate of treatment interruption due to adverse events was less than 7%.1
“Type 2 diabetes is a progressive disease. Many people with this disease cannot reach their A1C goals through diet and exercise. This monotherapy clinical trial aims to evaluate the use of tirzepatide alone for several important diabetes treatment goals. Impacts, including blood sugar control and weight loss,” said Julio RosenstockDirector of the Dallas Diabetes Research Center in Medical City, Medical City and principal investigator of SURPASS-1. “In the SURPASS-1 results, tirzepatide led to significant improvements in all primary and key secondary endpoints, clinically significant A1C reduction and weight loss in study participants with relatively short duration of type 2 diabetes.”
Tirzepatide is a new type of research di-glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptor agonist, once a week, it integrates the effects of GIP and GLP-1 incretin into one molecule, which represents A new class of drugs under study for the treatment of type 2 diabetes.
For two estimatesiiAll three doses of tirzepatide were statistically significant in terms of A1C and weight decrease from baseline, and the percentage of participants with A1C below 7% (the American Diabetes Association’s recommended target for diabetic patients) or below 5.7%.1
At 40 weeks, tirzepatide caused a significant reduction in fasting blood glucose (FSG) compared to placebo. In an additional secondary endpoint, all three doses of tirzepatide had an average two-hour postprandial glucose value of less than 140 mg/dL (considered normal in individuals without diabetes).2
Specifically, the results of the efficacy estimates show:
- A1C change: -1.87% (5 mg), -1.89% (10 mg), -2.07% (15 mg), +0.04% (placebo)
- Weight loss: -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)
- Percentage of participants achieving A1C <7%: 87% (5 mg), 92% (10 mg), 88% (15 mg), 20% (placebo)
- Percentage of participants achieving A1C <5.7%: 34% (5 mg), 31% (10 mg), 52% (15 mg), 1% (placebo)
- FSG changes: -43.6 mg/dL (5 mg), -45.9 mg/dL (10 mg), -49.3 mg/dL (15 mg), +12.9 mg/dL (placebo)
Estimated treatment planthree The results show that:
- A1C reduction: -1.75% (5 mg), -1.71% (10 mg), -1.69% (15 mg), -0.09% (placebo)
- Weight loss: -6.3 kg (5 mg),…
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