743-P: Effect of Once-Weekly TZP on Glycemic Control by Baseline Age in Patient Subpopulations from the SURPASS Trials

Abstract

Tirzepatide (TZP) is a dual GIP and GLP-1 receptor agonist developed for the treatment of patients with type 2 diabetes (T2D) . The SURPASS clinical trials demonstrated efficacy and safety of TZP 5, 10, and 15 mg, administered once weekly in patients with T2D. This post-hoc analysis of the 5 SURPASS studies was undertaken to assess the efficacy of TZP in subgroups of subjects <65 years and ≥65 years of age. Prespecified subgroup analyses were conducted on the mITT population in all 5 global Phase 3 trials to assess the effects of treatment (TZP vs. placebo or active comparator) on change from baseline in HbA1c. End of treatment HbA1c was evaluated at week 40 or 52. Efficacy estimands, based on data collected from participants on treatment and without rescue medication, were utilized for all analyses reported here. For all 5 studies, analyses of change from baseline in HbA1c at 40 or 52 weeks for both age subgroups were consistent with the primary study results, with the treatment differences favoring all 3 doses of TZP compared with placebo (SURPASS-1 and -5) or active comparator (SURPASS-2, -3 and -4) (Figure) . The most frequent adverse events with TZP were mild-to-moderate, gastrointestinal-related and occurred during the dose-escalation period. In all 5 trials and for subjects in both prespecified age subgroups, TZP demonstrated significantly greater reductions in HbA1c versus placebo or active comparator. Disclosure C.H.Wysham: Research Support; Abbott, Corcept Therapeutics, Eli Lilly and Company, Mylan N.V., Novo Nordisk. S.Tofe: Advisory Panel; Lilly Diabetes, Novo Nordisk, Research Support; Lilly Diabetes, Novo Nordisk, Speaker's Bureau; Lilly Diabetes, Novo Nordisk. H.Sapin: Employee; Eli Lilly and Company. R.Malik: None. L.M.Neff: Employee; Eli Lilly and Company, Research Support; Amryt Pharma Plc, Novo Nordisk, Stock/Shareholder; Eli Lilly and Company.