ObesityPhase 4NCT05579249
A Research Study Comparing Wegovy to Other Weight Management Drugs in People Living With Obesity in America
A Phase 4 study testing Semaglutide, Orlistat and Phentermine/Topiramate in people with Obesity, run by Novo Nordisk A/S at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Semaglutide, Orlistat and Phentermine/Topiramate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2023to 27 Nov 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 exclusion criteria, which in the investigator's opinion might jeopardise participant's safety or compliance with protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nutrition Research Centre
Loma Linda, California, 92354
About this study
Official title: Effectiveness of Semaglutide 2.4 mg vs. Commercially Available Medications for Chronic Weight Management in Participants With Obesity in a Multi-employer Setting in The US - a Pragmatic Clinical Study
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).
- Conditions
- Obesity
- Being tested
- Semaglutide, Orlistat, Phentermine/Topiramate, Naltrexone/Bupropion, Liraglutide
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Also called Wegovy
Participants will receive semaglutide 2.4 milligrams (mg) subcutaneous (s.c.) injection once weekly for 52 weeks.
OrlistatDrug
Also called Xenical
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.
Phentermine/TopiramateDrug
Also called Qsymia
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.
Naltrexone/BupropionDrug
Also called Contrave
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.
LiraglutideDrug
Also called Saxenda
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.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Participants will receive semaglutide 2.4 milligrams (mg) subcutaneous (s.c.) injection once weekly for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. Receives: Drug: Semaglutide |
| Other anti-obesity medication | Active comparator | Participants will receive 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 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. Receives: Drug: Orlistat; Drug: Phentermine/Topiramate; Drug: Naltrexone/Bupropion; Drug: Liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At end of treatment (week 52)
Secondary outcomes (8)
Percentage Change in Body Weight
Percentage change in body weight from week 0 to week 52 is presented.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)).
Measured: Baseline (week 0), end of treatment (week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start19 Jan 2023
- Primary completion27 Nov 2024
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579249
- Sponsor's protocol ID
- NN9536-4741
- Other IDs
- U1111-1263-7301
- Status last verified
- Dec 2025
- First submitted
- 11 Oct 2022
- Last updated
- 14 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Semaglutide 2.4 mg vs. Commercially Available Medications for Chronic Weight Management in Participants With Obesity in a Multi-employer Setting in The US - a Pragmatic Clinical Study
- ClinicalTrials.gov ID
- NCT05579249
- Acronym / sponsor ID
- NN9536-4741
- Conditions
- Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 13 Oct 2022 (actual)
- Results
- Posted 14 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: SemaglutideParticipants will receive semaglutide 2.4 milligrams (mg) subcutaneous (s.c.) injection once weekly for 52 weeks as adjuncts to a reduced-calorie diet and increased physical activity for chronic weight management. |
| Other anti-obesity medication | Active comparator | Drug: Orlistat, Drug: Phentermine/Topiramate, Drug: Naltrexone/Bupropion, Drug: LiraglutideParticipants will receive 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 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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 exclusion criteria, which in the investigator's opinion might jeopardise participant's safety or compliance with protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideAlso: WegovyParticipants will receive semaglutide 2.4 milligrams (mg) subcutaneous (s.c.) injection once weekly for 52 weeks. | Drug | Semaglutide |
| OrlistatAlso: XenicalParticipants 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. | Drug | Other anti-obesity medication |
| Phentermine/TopiramateAlso: QsymiaParticipants 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. | Drug | Other anti-obesity medication |
| Naltrexone/BupropionAlso: ContraveParticipants 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. | Drug | Other anti-obesity medication |
| LiraglutideAlso: SaxendaParticipants 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. | Drug | Other anti-obesity medication |
Primary outcome
Number of Participants Who Achieved Greater Than or Equal to (≥) 10.0 Percent (%) Body Weight Reduction (Yes/no)
Time frame: 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.
8 secondary outcomes
Percentage Change in Body Weight
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
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)
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)
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)
Time frame: At end of treatment (week 52)
Percentage of Days Covered (PDC) by Study Product
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)
Time frame: At end of treatment (week 52)
Change in Work Limitations Questionnaire 25-item Version (WLQ-25), Total Score (TS)
Time frame: Baseline (week 0), end of treatment (week 52)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide, Orlistat and Phentermine/Topiramate in people with Obesity, run by Novo Nordisk A/S at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Achieved Greater Than or Equal to (≥) 10.0 Percent (%) Body Weight Reduction (Yes/no) (time frame: At end of treatment (week 52)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.