A Research Study Comparing Wegovy to Other Weight Management Drugs in People Living With Obesity in America

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).

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Semaglutide; Drug: Orlistat; Drug: Phentermine/Topiramate; Drug: Naltrexone/Bupropion; Drug: Liraglutide

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Nutrition Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 exclusion criteria, which in the investigator's opinion might jeopardise participant's safety or compliance with protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Semaglutide; 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.	Drug: Semaglutide; Participants will receive semaglutide 2.4 milligrams (mg) subcutaneous (s.c.) injection once weekly for 52 weeks.; Other Names: Wegovy
Active Comparator: Other anti-obesity medication; 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.	Drug: Orlistat; 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.; Other Names: Xenical; Drug: Phentermine/Topiramate; 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.; Other Names: Qsymia; Drug: Naltrexone/Bupropion; 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.; Other Names: Contrave; Drug: Liraglutide; 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.; Other Names: Saxenda

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At end of treatment (week 52)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change in Body Weight	Percentage change in body weight from week 0 to week 52 is presented.	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.	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.	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.	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.	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.	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.	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)).	Baseline (week 0), end of treatment (week 52)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2023
• Primary Completion (Actual): November 27, 2024
• Study Completion (Actual): November 27, 2024

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Lactones; Heterocyclic Compounds, 4 or More Rings; Naloxone; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Ketones; Gastrointestinal Hormones; Glucagon-Like Peptides; Proglucagon; Glucagon-Like Peptide 1; Propiophenones; Liraglutide; Orlistat; Naltrexone; Bupropion; semaglutide; Qsymia; bupropion hydrochloride, naltrexone hydrochoride drug combination
• Other Study ID Numbers: NN9536-4741; U1111-1263-7301 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes