Eli Lilly: Tirzepatide Significantly Reduced A1C And Body Weight In Two Phase 3 SURPASS Trials

Eli Lilly and Co. (LLY) said Wednesday that Tirzepatide significantly reduced A1C and body weight from baseline in adults with type 2 diabetes in the company’s SURPASS-3 and SURPASS-5 phase 3 clinical trials after 52 weeks and 40 weeks, respectively.

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. It represents a new class of medicines being studied for the treatment of type 2 diabetes.

Eli Lilly noted that in topline results, the primary and all key secondary endpoints were met for both estimands 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 estimand, the highest dose of tirzepatide of 15 mg reduced A1C by 2.37 percent and body weight by 12.9 kg in SURPASS-3, and reduced A1C by 2.59 percent and body weight by 10.9 kg 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.

Eli Lilly noted that 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.

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