Abstract
INTRODUCTION: In SURMOUNT-2, a phase 3, randomized clinical trial, tirzepatide treatment resulted in clinically meaningful reduction in bodyweight among people with obesity or overweight and T2D. The current analysis evaluated the effects of tirzepatide treatment on self-reported health-related quality of life (HRQoL) outcomes among SURMOUNT-2 participants. METHODS: SURMOUNT-2 participants were randomly assigned (1:1:1) to receive either tirzepatide 10 mg (n = 312), tirzepatide 15 mg (n = 311), or placebo (n = 315) for 72 weeks as an adjunct to diet and exercise. Self-reported HRQoL was assessed in terms of changes from baseline to week 72 in Short Form-36 Version 2 Health Survey acute form (SF-36v2), Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT), EQ-5D 5-level Version (EQ-5D-5L) Health State Index (UK) and associated EQ visual analog scale (VAS), and Patient Global Impression of Status (PGIS) for Physical Activity. Post hoc analyses evaluated changes in HRQoL outcomes by categorical percent weight reduction targets (> 0 to < 5%, ≥ 5%, ≥ 10%, ≥ 15%, ≥ 20%, ≥ 25%, and ≥ 30%) and by self-reported baseline physical function limitations (based on PGIS) among tirzepatide-treated participants. RESULTS: At week 72, tirzepatide treatment was associated with significantly larger improvements than placebo in the SF-36v2 Physical Component Summary score, SF-36v2 physical functioning, bodily pain, general health, vitality, and social functioning domain scores, all IWQOL-Lite-CT scores, and EQ VAS score. Tirzepatide-treated participants who achieved greater weight reduction targets showed numerically larger improvements in HRQoL scores relative to those with lower percent weight reduction. For all HRQoL measures, participants with physical function limitations at baseline showed greater improvements than those without limitations. CONCLUSIONS: Tirzepatide treatment was associated with improved self-reported HRQoL outcomes compared with placebo among people with obesity or overweight with T2D. Participants achieving greater bodyweight reductions and those with physical function limitations at baseline showed greater improvements in HRQoL. CLINICAL TRIAL REGISTRATION NUMBER FOR SURMOUNT-2: NCT04657003.