Back to resultsA Research Study Comparing Wegovy to Other Weight Management Drugs in People Living With Obesity in America
Primary Purpose
Obesity
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Semaglutide
Orlistat
Phentermine/Topiramate
Naltrexone/Bupropion
Liraglutide
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
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 the protocol.
Sites / Locations
- Novo Nordisk Investigational SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Semaglutide
Other anti-obesity medication
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of Participants Who Achieve Body Weight Reduction Greater Than Equal To (≥) 10.0 Percentage (%) (Yes/No)
Measured as count of participants.
Secondary Outcome Measures
Change in Body Weight
Measured in percentage.
Change in Impact of Weight on Quality of Life-Lite For Clinical Trials (IWQOL-Lite-CT) Physical Function Domain
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)
Measured as count of participants.
Number of Participants Who Achieve Body Weight Reduction ≥ 20.0% (Yes/No)
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)
Measured as count of participants.
Proportion of Days Covered (PDC) by Study Product
Measured in percentage.
Number of Participants Who Are Covered by Study Product ≥ 80% of Days (Yes/No)
Measured as count of participants.
Change in Work Limitations Questionnaire 25-item Version (WLQ-25), Total Score
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05579249
Brief Title
A Research Study Comparing Wegovy to Other Weight Management Drugs in People Living With Obesity in America
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2023 (Actual)
Primary Completion Date
November 12, 2024 (Anticipated)
Study Completion Date
February 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
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
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Semaglutide
Arm Type
Experimental
Arm Description
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.
Arm Title
Other anti-obesity medication
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Other Intervention Name(s)
Wegovy
Intervention Description
Participants will receive semaglutide 2.4 milligrams (mg) subcutaneous (s.c.) injection once weekly for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Orlistat
Other Intervention Name(s)
Xenical
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Phentermine/Topiramate
Other Intervention Name(s)
Qsymia
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Naltrexone/Bupropion
Other Intervention Name(s)
Contrave
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Other Intervention Name(s)
Saxenda
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Who Achieve Body Weight Reduction Greater Than Equal To (≥) 10.0 Percentage (%) (Yes/No)
Description
Measured as count of participants.
Time Frame
At week 52
Secondary Outcome Measure Information:
Title
Change in Body Weight
Description
Measured in percentage.
Time Frame
Week 0 to week 52
Title
Change in Impact of Weight on Quality of Life-Lite For Clinical Trials (IWQOL-Lite-CT) Physical Function Domain
Description
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.
Time Frame
Week 0 to week 52
Title
Number of Participants Who Achieve Body Weight Reduction ≥ 15.0% (Yes/No)
Description
Measured as count of participants.
Time Frame
At week 52
Title
Number of Participants Who Achieve Body Weight Reduction ≥ 20.0% (Yes/No)
Description
Measured as count of participants.
Time Frame
At week 52
Title
Number of Participants Who Achieve Change in IWQOL-Lite For CT Physical Function Domain Score Greater Than (>) 14.6 (Yes/No)
Description
Measured as count of participants.
Time Frame
At week 52
Title
Proportion of Days Covered (PDC) by Study Product
Description
Measured in percentage.
Time Frame
Week 0 to week 52
Title
Number of Participants Who Are Covered by Study Product ≥ 80% of Days (Yes/No)
Description
Measured as count of participants.
Time Frame
At week 52
Title
Change in Work Limitations Questionnaire 25-item Version (WLQ-25), Total Score
Description
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.
Time Frame
Week 0 to week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novo Nordisk
Phone
(+1) 866-867-7178
Email
clinicaltrials@novonordisk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency (dept. 2834)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com
Learn more about this trial
A Research Study Comparing Wegovy to Other Weight Management Drugs in People Living With Obesity in America
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