Eli Lilly's Tirzepatide Reduces A1C And Body Weight, Late-Stage Studies In Type 2 Diabetes Show

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  • Eli Lilly And Co (NYSE: LLY) have announced topline results from two Phase 3 studies, SURPASS-3 and SURPASS-5, evaluating Tirzepatide in adults with type 2 diabetes. Data showed that Tirzepatide led to significant A1C and body weight reductions from baseline after 52 (SURPASS-3) weeks and 40 (SURPASS-5) weeks, respectively.
  • Using the efficacy estimand, the highest dose of tirzepatide (15 mg) reduced A1C by 2.37% and body weight by 12.9 kg (13.9%) in SURPASS-3, and reduced A1C by 2.59% and body weight by 10.9 kg (11.6%) in SURPASS-5.
  • At the highest dose, 62.4% of SURPASS-5 participants achieved an A1C of less than 5.7%, 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 an investigational once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptor agonist that integrates both incretins' actions into a single molecule.
  • SURPASS-3 was a 52-week 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.
  • SURPASS-5 was a 40-week trial comparing the efficacy and safety of three doses of tirzepatide (5 mg, 10 mg, and 15 mg) compared to placebo, both as an add-on to titrated insulin glargine with or without metformin in adults with type 2 diabetes.
  • The complete SURPASS-3 and SURPASS-5 data have not yet been evaluated but will be presented at the American Diabetes Association's 81st Scientific Sessions and published in a peer-reviewed publication in 2021.
  • Price Action: LLY stock increased 1.1% at $208 in premarket trading on the last check Wednesday.
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Posted In: BiotechNewsHealth CareFDAGeneralDiabetesPhase 3 Study
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