Effect of semaglutide 2.4 mg on physical functioning and weight‐ and health‐related quality of life in adults with overweight or obesity: Patient‐reported outcomes from the STEP 1–4 trials

Aims To summarize the effects of semaglutide 2.4 mg on weight‐related quality of life (WRQOL) and health‐related quality of life (HRQOL), focusing on the confirmatory secondary endpoint of physical functioning. Materials and Methods The STEP 1–4 Phase 3a, 68‐week, double‐blind, randomized controlled...

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Published in:Diabetes, obesity & metabolism obesity & metabolism, 2024-07, Vol.26 (7), p.2945-2955
Main Authors: Rubino, Domenica, Bjorner, Jakob B., Rathor, Naveen, Sharma, Arya M., Huth Smith, Lisa, Wharton, Sean, Wadden, Thomas, Zeuthen, Niels, Kolotkin, Ronette L.
Format: Article
Language:English
Subjects:
Adult
Double-Blind Method
Female
GLP‐1
Glucagon-Like Peptides - therapeutic use
Humans
Hypoglycemic Agents - therapeutic use
Male
Middle Aged
Obesity - drug therapy
Obesity - psychology
obesity therapy
Overweight - drug therapy
Patient Reported Outcome Measures
patient‐reported outcomes
Quality of Life
semaglutide
weight control
Weight Loss - drug effects
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Summary:Aims To summarize the effects of semaglutide 2.4 mg on weight‐related quality of life (WRQOL) and health‐related quality of life (HRQOL), focusing on the confirmatory secondary endpoint of physical functioning. Materials and Methods The STEP 1–4 Phase 3a, 68‐week, double‐blind, randomized controlled trials assessed the efficacy and safety of semaglutide 2.4 mg versus placebo in individuals with overweight/obesity. WRQOL and HRQOL were assessed by change from baseline to Week 68 in two different but complementary measures, the Impact of Weight on Quality of Life‐Lite Clinical Trials Version (IWQOL‐Lite‐CT; STEP 1 and 2) and the SF‐36v2 Health Survey Acute (SF‐36v2; STEP 1–4). Results Superiority for semaglutide 2.4 mg over placebo based on IWQOL‐Lite‐CT and SF‐36v2 physical functioning scores was confirmed in STEP 1 and 2 and in STEP 1, 2 and 4, respectively. At Week 68, a greater proportion of participants treated with semaglutide 2.4 mg than with placebo reached meaningful within‐person change (MWPC) thresholds for IWQOL‐Lite‐CT Physical Function scores in STEP 1 (51.8% vs. 28.3%; p 
ISSN:1462-8902
1463-1326
1463-1326
DOI:10.1111/dom.15620