Hunter Gibble Theresa, Cao Dachuang, Zhang Xiaotian Michelle, Xavier Neena Agarwal, Poon Jiat Ling, Fitch Angela
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Knownwell, 15 Oak St Suite 3, Needham, MA, USA.
Diabetes Ther. 2025 May;16(5):977-991. doi: 10.1007/s13300-025-01723-w. Epub 2025 Mar 22.
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.
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.
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.
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.
在SURMOUNT-2这一3期随机临床试验中，替尔泊肽治疗使肥胖或超重合并2型糖尿病患者的体重出现了具有临床意义的下降。当前分析评估了替尔泊肽治疗对SURMOUNT-2参与者自我报告的健康相关生活质量（HRQoL）结果的影响。
SURMOUNT-2参与者被随机分配（1:1:1）接受替尔泊肽10毫克（n = 312）、替尔泊肽15毫克（n = 311）或安慰剂（n = 315）治疗72周，作为饮食和运动的辅助治疗。自我报告的HRQoL通过从基线到第72周的简短36项健康调查简表第2版（SF-36v2）、体重对生活质量的影响-简化版-临床试验版（IWQOL-Lite-CT）、EQ-5D 5级版（EQ-5D-5L）健康状态指数（英国）及相关EQ视觉模拟量表（VAS）以及身体活动的患者总体状况印象（PGIS）的变化进行评估。事后分析按分类减重目标（>0至<5%、≥5%、≥10%、≥15%、≥20%、≥25%和≥30%）以及替尔泊肽治疗参与者中自我报告的基线身体功能限制（基于PGIS）评估HRQoL结果的变化。
在第72周时，替尔泊肽治疗与安慰剂相比，在SF-36v2身体成分汇总得分、SF-36v2身体功能、身体疼痛、总体健康、活力和社会功能领域得分、所有IWQOL-Lite-CT得分以及EQ VAS得分方面均有显著更大的改善。实现更大减重目标的替尔泊肽治疗参与者相对于减重百分比更低者，在HRQoL得分上显示出数值上更大的改善。对于所有HRQoL指标，基线时有身体功能限制的参与者比没有限制的参与者改善更大。
与安慰剂相比，替尔泊肽治疗使肥胖或超重合并2型糖尿病患者自我报告的HRQoL结果得到改善。实现更大体重减轻的参与者以及基线时有身体功能限制的参与者在HRQoL方面改善更大。SURMOUNT-2临床试验注册号：NCT04657003。
