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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05579249

Collaborator

(none)

500

Enrollment

Location

Arms

24.9

Anticipated Duration (Months)

20.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: Semaglutide Drug: Orlistat Drug: Phentermine/Topiramate Drug: Naltrexone/Bupropion Drug: Liraglutide	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 19, 2023

Anticipated Primary Completion Date :

Nov 12, 2024

Anticipated Study Completion Date :

Feb 15, 2025

Arms and Interventions

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

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

Other Names:

Qsymia

Drug: Naltrexone/Bupropion

Other Names:

Contrave

Drug: Liraglutide

Other Names:

Saxenda

Outcome Measures

Primary Outcome Measures

Number of Participants Who Achieve Body Weight Reduction Greater Than Equal To (≥) 10.0 Percentage (%) (Yes/No) [At week 52]
Measured as count of participants.

Secondary Outcome Measures

Change in Body Weight [Week 0 to week 52]
Measured in percentage.
Change in Impact of Weight on Quality of Life-Lite For Clinical Trials (IWQOL-Lite-CT) Physical Function Domain [Week 0 to week 52]
IWQOL-Lite-CT is a 20-item patient reported outcome instrument used to assess the impact of body weight changes on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. The possible score range for physical function score is 0 to 100. Higher values on physical function score of the IWQOL-Lite-CT indicate improved patient functioning. Measured as score.
Number of Participants Who Achieve Body Weight Reduction ≥ 15.0% (Yes/No) [At week 52]
Measured as count of participants.
Number of Participants Who Achieve Body Weight Reduction ≥ 20.0% (Yes/No) [At week 52]
Measured as count of participants.
Number of Participants Who Achieve Change in IWQOL-Lite For CT Physical Function Domain Score Greater Than (>) 14.6 (Yes/No) [At week 52]
Measured as count of participants.
Proportion of Days Covered (PDC) by Study Product [Week 0 to week 52]
Measured in percentage.
Number of Participants Who Are Covered by Study Product ≥ 80% of Days (Yes/No) [At week 52]
Measured as count of participants.
Change in Work Limitations Questionnaire 25-item Version (WLQ-25), Total Score [Week 0 to week 52]
The Work Limitations Questionnaire (WLQ-25), version 2.1, is a 25-item questionnaire that measures the degree to which health problems interfere with specific aspects of job performance and the productivity impact of these work limitations during the past 2 weeks using a 5-point Likert scale response option. It is a self-administrated questionnaire consisting of 4 domains of work limitation: Time Management (5), Physical Demands (6), Mental/Interpersonal (9), Output Demands (5). The responses are used to calculate a total WLQ index score. Lower scores indicate less work limitation. Measured as score.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.