Obesity
Conditions
Brief summary
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).
Interventions
DRUGSemaglutide
Participants will receive semaglutide 2.4 milligrams (mg) subcutaneous (s.c.) injection once weekly for 52 weeks.
DRUGOrlistat
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.
DRUGLiraglutide
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.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Body mass index (BMI) greater than equal to 30.0 kilogram per meter square (kg/m\^2). * Employed at randomisation by one of the selected employers and expecting to be so for the duration of the study.
Exclusion criteria
* Known or suspected hypersensitivity or contraindications to Wegovy or related products according to the label. * Known or suspected hypersensitivity or contraindications to all of the other Anti-Obesity Medications (AOMs) for chronic weight management (Xenical, Qsymia, Contrave, and Saxenda) or related products according to the labels. * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method. * History of type 1 or type 2 diabetes mellitus. * Any disorder, unwillingness, or inability, not covered by any of the other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved Greater Than or Equal to (≥) 10.0 Percent (%) Body Weight Reduction (Yes/no) | At end of treatment (week 52) | Number of participants who achieved greater than or equal to 10.0% body weight reduction (yes/no) at week 52 is presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Covered by Study Product Greater Than or Equal to (≥) 80% of Days (Yes/no) | At end of treatment (week 52) | Number of participants covered by study product ≥80% of days (yes/no) from week 0 to week 52 is presented. |
| Percentage Change in Body Weight | Baseline (week 0), end of treatment (week 52) | Percentage change in body weight from week 0 to week 52 is presented. |
| Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Domain | Baseline (week 0), end of treatment (week 52) | 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. |
| Percentage of Days Covered (PDC) by Study Product | From week 0 to week 52 | 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. |
| Number of Participants Who Achieved Greater Than or Equal to (≥) 20.0% Body Weight Reduction (Yes/no) | At end of treatment (week 52) | Number of participants who achieved more than or equal to 20.0% body weight reduction (yes/no) at week 52 is presented. |
| 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) | At end of treatment (week 52) | 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. |
| Change in Work Limitations Questionnaire 25-item Version (WLQ-25), Total Score (TS) | Baseline (week 0), end of treatment (week 52) | 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)). |
| Number of Participants Who Achieved Greater Than or Equal to (≥) 15.0% Body Weight Reduction (Yes/no) | At end of treatment (week 52) | Number of participants who achieved more than or equal to 15.0% body weight reduction (yes/no) at week 52 is presented. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at one site in United States.
Participants by arm
| Arm | Count |
|---|---|
| Semaglutide 2.4 mg Participants received once weekly semaglutide 2.4 milligrams (mg) subcutaneous (s.c) injection for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. | 250 |
| Other Anti-obesity Medications (AOMs) Participants received one of 4 commercially available anti-obesity medication chosen by the study doctor for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. The 4 anti-obesity medications were 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. | 250 |
| Total | 500 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 2 |
| Overall Study | Lost to Follow-up | 33 | 52 |
| Overall Study | Physician Decision | 2 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Other Anti-obesity Medications (AOMs) | Total | Semaglutide 2.4 mg |
|---|---|---|---|
| Age, Continuous | 42.0 Years STANDARD_DEVIATION 10.3 | 41.3 Years STANDARD_DEVIATION 9.8 | 40.6 Years STANDARD_DEVIATION 9.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 150 Participants | 309 Participants | 159 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 100 Participants | 191 Participants | 91 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 8 Participants | 18 Participants | 10 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 24 Participants | 17 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 50 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 202 Participants | 395 Participants | 193 Participants |
| Sex: Female, Male Female | 223 Participants | 448 Participants | 225 Participants |
| Sex: Female, Male Male | 27 Participants | 52 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 250 | 2 / 250 |
| other Total, other adverse events | 0 / 242 | 0 / 242 |
| serious Total, serious adverse events | 3 / 242 | 8 / 242 |
Outcome results
Primary
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)
Population: Full analysis set included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | Number of Participants Who Achieved Greater Than or Equal to (≥) 10.0 Percent (%) Body Weight Reduction (Yes/no) | Yes | 132 Participants |
| Semaglutide 2.4 mg | Number of Participants Who Achieved Greater Than or Equal to (≥) 10.0 Percent (%) Body Weight Reduction (Yes/no) | No | 75 Participants |
| Other Anti-obesity Medications (AOMs) | Number of Participants Who Achieved Greater Than or Equal to (≥) 10.0 Percent (%) Body Weight Reduction (Yes/no) | Yes | 61 Participants |
| Other Anti-obesity Medications (AOMs) | Number of Participants Who Achieved Greater Than or Equal to (≥) 10.0 Percent (%) Body Weight Reduction (Yes/no) | No | 116 Participants |
Comparison: Week 52 responses were analysed using a binary regression model with randomized treatment as factor and baseline body weight as covariate.p-value: <0.000195% CI: [2.12, 4.78]Regression, Linear
Secondary
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)
Population: Full analysis set included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Domain | 25.6 Score on a scale | Standard Deviation 21.2 |
| Other Anti-obesity Medications (AOMs) | Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Domain | 22.6 Score on a scale | Standard Deviation 24.4 |
Secondary
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)
Population: Full analysis set included all randomized participants Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Change in Work Limitations Questionnaire 25-item Version (WLQ-25), Total Score (TS) | -0.034 Score on a scale | Standard Deviation 0.07 |
| Other Anti-obesity Medications (AOMs) | Change in Work Limitations Questionnaire 25-item Version (WLQ-25), Total Score (TS) | -0.016 Score on a scale | Standard Deviation 0.048 |
Secondary
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)
Population: Full analysis set included all randomized participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | Number of Participants Covered by Study Product Greater Than or Equal to (≥) 80% of Days (Yes/no) | Yes | 168 Participants |
| Semaglutide 2.4 mg | Number of Participants Covered by Study Product Greater Than or Equal to (≥) 80% of Days (Yes/no) | No | 82 Participants |
| Other Anti-obesity Medications (AOMs) | Number of Participants Covered by Study Product Greater Than or Equal to (≥) 80% of Days (Yes/no) | Yes | 113 Participants |
| Other Anti-obesity Medications (AOMs) | Number of Participants Covered by Study Product Greater Than or Equal to (≥) 80% of Days (Yes/no) | No | 137 Participants |
Secondary
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)
Population: Full analysis set included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | 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) | Yes | 138 Participants |
| Semaglutide 2.4 mg | 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) | No | 51 Participants |
| Other Anti-obesity Medications (AOMs) | 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) | Yes | 108 Participants |
| Other Anti-obesity Medications (AOMs) | 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) | No | 55 Participants |
Secondary
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)
Population: Full analysis set included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | Number of Participants Who Achieved Greater Than or Equal to (≥) 15.0% Body Weight Reduction (Yes/no) | Yes | 93 Participants |
| Semaglutide 2.4 mg | Number of Participants Who Achieved Greater Than or Equal to (≥) 15.0% Body Weight Reduction (Yes/no) | No | 114 Participants |
| Other Anti-obesity Medications (AOMs) | Number of Participants Who Achieved Greater Than or Equal to (≥) 15.0% Body Weight Reduction (Yes/no) | Yes | 25 Participants |
| Other Anti-obesity Medications (AOMs) | Number of Participants Who Achieved Greater Than or Equal to (≥) 15.0% Body Weight Reduction (Yes/no) | No | 152 Participants |
Secondary
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)
Population: Full analysis set included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Semaglutide 2.4 mg | Number of Participants Who Achieved Greater Than or Equal to (≥) 20.0% Body Weight Reduction (Yes/no) | Yes | 49 Participants |
| Semaglutide 2.4 mg | Number of Participants Who Achieved Greater Than or Equal to (≥) 20.0% Body Weight Reduction (Yes/no) | No | 158 Participants |
| Other Anti-obesity Medications (AOMs) | Number of Participants Who Achieved Greater Than or Equal to (≥) 20.0% Body Weight Reduction (Yes/no) | Yes | 8 Participants |
| Other Anti-obesity Medications (AOMs) | Number of Participants Who Achieved Greater Than or Equal to (≥) 20.0% Body Weight Reduction (Yes/no) | No | 169 Participants |
Secondary
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)
Population: Full analysis set included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Percentage Change in Body Weight | -13.6 Percentange change in body weight | Standard Deviation 8.7 |
| Other Anti-obesity Medications (AOMs) | Percentage Change in Body Weight | -7.4 Percentange change in body weight | Standard Deviation 7.3 |
Secondary
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
Population: Full analysis set included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Semaglutide 2.4 mg | Percentage of Days Covered (PDC) by Study Product | 83.7 Percentage of days covered | Standard Deviation 24.6 |
| Other Anti-obesity Medications (AOMs) | Percentage of Days Covered (PDC) by Study Product | 70.8 Percentage of days covered | Standard Deviation 28.6 |