720-P: Change in Body Weight from Baseline with Tirzepatide: Sex Subgroup Analysis of the SURPASS Studies

Abstract

Five Phase 3 SURPASS trials have shown robust efficacy of novel dual GIP/GLP-1 receptor agonist, tirzepatide, in glycaemic control and body weight (BW) loss in adults with Type 2 Diabetes (T2D) . A key secondary endpoint investigated the effect of tirzepatide (5, 10, and 15 mg) versus placebo or active comparators on mean BW change from baseline to endpoint. To determine whether weight-lowering effects of tirzepatide depend on the sex of study participants, we conducted a post-hoc subgroup analysis of SURPASS (S) -1 to -5 trials. BW change in the sex subgroups was assessed in patients while on treatment without rescue medication (efficacy estimand) in the modified intention-to-treat (mITT) population, defined as all randomized patients who received at least one dose of study drug. All tirzepatide doses significantly reduced BW compared to placebo or active comparators regardless of the sex of study participants (S-1 to -5 p<0.001) . The most frequent AEs were mild-to-moderate, GI-related, and occurred during the dose-escalation period. Disclosure A.W.Plat: None. N.Rasouli: Advisory Panel; Eli Lilly and Company, Novo Nordisk, Sanofi, Research Support; Allergan, Eli Lilly and Company, Novo Nordisk. J.Peleshok: Employee; Eli Lilly and Company, Eli Lilly and Company. H.Sapin: Employee; Eli Lilly and Company. J.Wilding: Advisory Panel; Alnylam Pharmaceuticals, Inc., AstraZeneca, Eli Lilly and Company, Mundipharma, Novo Nordisk A/S, Rhythm Pharmaceuticals, Inc., Sanofi, Research Support; AstraZeneca, Speaker's Bureau; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly Diabetes, Novo Nordisk A/S, Takeda Pharmaceutical Company Limited. Funding Eli Lilly and Company