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Abstract Disclosure: T.M. Gibble: Employee; Self; Employment and stockholder, Eli Lilly and Company. D. Cao: Employee; Self; Employment and stockholder, Eli Lilly and Company. M. Murphy: Employee; Self; Employment and stockholder, Eli Lilly and Company. I. Jouravskaya: Employee; Self; Employment and stockholder, Eli Lilly and Company. B. Liao: Employee; Self; Employment and stockholder, Eli Lilly and Company. Background: Tirzepatide is a once weekly glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist approved in the U.S. for treatment of type 2 diabetes (T2D) and obesity. In the phase 3 SURMOUNT-4 trial with randomized withdrawal of tirzepatide maximum tolerated dose (MTD) after the first 36 weeks, continuing tirzepatide for a total of 88 weeks led to a mean weight reduction of 25.3% from baseline compared to 9.9% for those who switched to placebo (PBO).1 This analysis evaluated the effect of tirzepatide versus PBO on mental and psychosocial health-related quality of life (HRQoL) outcomes using the SURMOUNT-4 trial data. Methods: Adults (n=783) with body mass index ≥30 or ≥27 kg/m2 and ≥1 obesity-related complication (excluding T2D) were enrolled in an open-label lead-in period to receive tirzepatide once weekly subcutaneously for 36 weeks, escalated to MTD (10 mg or 15 mg). At week (W) 36, 670 participants were randomized 1:1 to continue tirzepatide MTD (n=335) or were switched to PBO (n=335) for 52 weeks. HRQoL was evaluated from W0 to W88 using the Short Form-36 Version 2 Health Survey (SF-36 v2) acute form and Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT), where the last observation before discontinuation was carried forward. Higher scores of SF-36v2 (Mental Component Summary MCS, role-emotional, and mental health), and IWQOL-Lite-CT (psychosocial composite) reflected better levels of mental function. Least square mean (LSM) changes and estimated treatment differences (ETD) between tirzepatide and PBO were calculated using an analysis of covariance model. Results: LSM changes in mental domain scores for SF-36 v2 and IWQOL-Lite-CT were comparable during lead-in (W0 to W36) between participants randomized to tirzepatide and PBO. Significant improvements were observed from W36 to W88 in SF-36v2 mental domain scores for tirzepatide versus PBO, with LSM scores ( ETD) as follows: MCS, 54.6, 52.9 (1.7, p=0.001); role-emotional, 53.0, 51.1 (1.9, p=0.001), and mental health, 55.4, 52.9 (2.4, p0.001), respectively. LSM change from W36 to W88 in SF-36 v2 mental domain scores for tirzepatide and PBO were: MCS, 0.1 and -1.6; role-emotional, 0.6 and -1.2, and mental health, 0.3 and -2.1, respectively. Tirzepatide showed significant improvements in IWQOL-Lite-CT psychosocial scores versus PBO from W36 to W88, with LSM scores ( ETD) of 87.7, 75.6 (12.1; p0.001), respectively. LSM change from W36 to W88 in IWQOL-Lite-CT psychosocial scores for tirzepatide and PBO were 5.1 and -7.0, respectively. Conclusion: In the SURMOUNT-4 trial, adults with overweight or obesity continuing on tirzepatide MTD showed significant and sustained improvements in mental and psychosocial HRQoL compared to those switching to placebo. 1Sattar N. 59th Annual Meeting European Association for the Study of Diabetes; Oct 2023; Hamburg, Germany. Presentation: 6/1/2024
Gibble et al. (Tue,) studied this question.