The purpose of this post approval pragmatic clinical study is to see how well semaglutide lowers body weight compared to other medication on the market used to treat obesity, across three US-based employers. These employers represent employees of diverse demography and job functions including hospitality, clerical, administrative, housekeeping, maintenance, and specialised employees across a range of socioeconomic and educational backgrounds. The study will also look at how weight loss affects physical functioning, quality of life and ability to work. It will also gather information on how satisfied participants are with the medication they take. Participants will either receive semaglutide or one of 4 approved anti-obesity medication (Xenical/Qsymia/Contrave/Saxenda).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Participants will receive semaglutide 2.4 milligrams (mg) subcutaneous (s.c.) injection once weekly for 52 weeks.
Participants will receive one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks. The 4 anti-obesity medications are orlistat per os \[by mouth\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection.
Participants will receive one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks. The 4 anti-obesity medications are orlistat per os \[by mouth\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection.
Participants will receive one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks. The 4 anti-obesity medications are orlistat per os \[by mouth\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection.
Participants will receive one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks. The 4 anti-obesity medications are orlistat per os \[by mouth\] (p.o.), phentermine/topiramate extended release p.o., naltrexone/bupropion extended release p.o. or liraglutide 3.0 mg s.c injection.
Nutrition Research Centre
Loma Linda, California, United States
Number of Participants Who Achieved Greater Than or Equal to (≥) 10.0 Percent (%) Body Weight Reduction (Yes/no)
Number of participants who achieved greater than or equal to 10.0% body weight reduction (yes/no) at week 52 is presented.
Time frame: At end of treatment (week 52)
Percentage Change in Body Weight
Percentage change in body weight from week 0 to week 52 is presented.
Time frame: Baseline (week 0), end of treatment (week 52)
Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Domain
The IWQOL-Lite-CT is a 20-item, obesity-specific patient-reported outcome (PRO) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. This outcome measure shows results for physical function domain.
Time frame: Baseline (week 0), end of treatment (week 52)
Number of Participants Who Achieved Greater Than or Equal to (≥) 15.0% Body Weight Reduction (Yes/no)
Number of participants who achieved more than or equal to 15.0% body weight reduction (yes/no) at week 52 is presented.
Time frame: At end of treatment (week 52)
Number of Participants Who Achieved Greater Than or Equal to (≥) 20.0% Body Weight Reduction (Yes/no)
Number of participants who achieved more than or equal to 20.0% body weight reduction (yes/no) at week 52 is presented.
Time frame: At end of treatment (week 52)
Number of Participants Who Achieved Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Domain Score Greater Than or Equal to (≥) 14.6 (Yes/no)
The IWQOL-Lite-CT is a 20-item, obesity-specific patient-reported outcome (PRO) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. This outcome measure shows results for physical function domain score ≥ 14.6.
Time frame: At end of treatment (week 52)
Percentage of Days Covered (PDC) by Study Product
Percentage of days covered by study product from week 0 to week 52 is presented. The percentage of days covered by the study product is determined by the duration on the study product divided by the planned study duration, multiplied by 100.
Time frame: From week 0 to week 52
Number of Participants Covered by Study Product Greater Than or Equal to (≥) 80% of Days (Yes/no)
Number of participants covered by study product ≥80% of days (yes/no) from week 0 to week 52 is presented.
Time frame: At end of treatment (week 52)
Change in Work Limitations Questionnaire 25-item Version (WLQ-25), Total Score (TS)
Work Limitations Questionnaire (WLQ-25) is a 25-item questionnaire that measures how health problems affect job performance and productivity over the past two weeks, using a 5-point Likert scale. It covers four domains: Time Management (5 items), Physical Demands (6), Mental/Interpersonal (9), and Output Demands (5). Each item is scored from 1 to 5, with subscale scores calculated as the average item score, then converted to a 0-100 scale using the formula: WLQ Scale Score= 25 × (average item score - 1). Thus, each subscale ranges from 0 (no limitation) to 100 (maximum limitation). The WLQ total score is computed by applying specific weights to each subscale and summing them: 0.00048 × Time scale + 0.00036 × Physical scale + 0.00096 × Mental/Interpersonal scale + 0.00106 × Output scale. This total is then transformed into the proportion of productivity loss using the formula: (1 - exp(-total score)).
Time frame: Baseline (week 0), end of treatment (week 52)
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