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INDIANAPOLIS, Feb. 17, 2021 /PRNewswire/ -- Tirzepatide led to significant A1C and body weight reductions from baseline in adults with type 2 diabetes in Eli Lilly and Company's (NYSE: LLY) SURPASS-3 and SURPASS-5 phase 3 clinical trials after 52 weeks and 40 weeks, respectively. In topline results, the primary and all key secondary endpoints were met for both estimandsi in SURPASS-3, which compared tirzepatide to titrated insulin degludec, and in SURPASS-5, which compared tirzepatide to placebo, both as an add-on to titrated insulin glargine.
Using the efficacy estimandii, the highest dose of tirzepatide (15 mg) reduced A1C by 2.37 percent and body weight by 12.9 kg (13.9 percent) in SURPASS-3, and reduced A1C by 2.59 percent and body weight by 10.9 kg (11.6 percent) in SURPASS-5. At the highest dose, 62.4 percent of SURPASS-5 participants – who had a mean duration of diabetes of 13.3 years – achieved an A1C of less than 5.7 percent, the level seen in people without diabetes. In both studies, the overall safety profile of tirzepatide was similar to that of the well-established glucagon-like peptide-1 (GLP-1) receptor agonist class, with gastrointestinal side effects being the most commonly reported adverse events and decreasing with continued dosing.
Tirzepatide is a novel investigational once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and 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.
"Tirzepatide delivered impressive A1C and body weight reductions in both studies and continued to achieve consistent efficacy and safety results in people living with type 2 diabetes, regardless of how long they have had the condition," said Mike Mason, president, Lilly Diabetes. "Significantly lowering A1C levels and weight are high priorities throughout the type 2 diabetes treatment journey, and the results we have seen from three SURPASS studies to date fuel our belief in tirzepatide's ability to meet those needs."
SURPASS-3SURPASS-3 was a 52-week randomized, open-label trial comparing the efficacy and safety of three doses of tirzepatide (5 mg, 10 mg and 15 mg) to titrated insulin degludec in adults with type 2 diabetes who have inadequate glycemic control on stable doses of metformin with or without an SGLT-2 inhibitor. Study participants were insulin-naïve and had a mean duration of diabetes of 8.4 years, a baseline A1C of 8.17 percent and a baseline weight of 94.3 kg.
The study met its primary and key secondary endpoints across both the efficacy and treatment-regimeniii estimands. All three tirzepatide doses (5 mg, 10 mg and 15 mg) led to superior A1C and body weight reductions compared to titrated insulin degludec (mean dose at 52 weeks was 48.8 units per dayiv). Across the three doses, up to 92.6 percent of participants on tirzepatide achieved an A1C of less than 7 percent (the American Diabetes Association's recommended target for people with diabetes). Further, in an additional secondary endpoint, up to 48.4 percent of participants treated with tirzepatide achieved an A1C of less than 5.7 percent.
SURPASS-3 Efficacy Estimand Results | ||||
Tirzepatide 5 mg | Tirzepatide 10 mg | Tirzepatide 15 mg | Insulin Degludeciv | |
A1C reduction from baseline of 8.17% | -1.93%* | -2.20%* | -2.37%* | -1.34% |
Weight change from baseline of 94.3 kg | -7.5 kg* (-8.1%) | -10.7 kg* (-11.4%) | -12.9 kg* (-13.9%) | +2.3 kg (+2.7%) |
Percent of participants achieving A1C
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