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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05579249
• Other study ID #: NN9536-4741
• Secondary ID: U1111-1263-7301
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 19, 2023
• Est. completion date: February 15, 2025

Study information

• Verified date: January 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: February 15, 2025
• Est. primary completion date: November 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Semaglutide
Participants will receive semaglutide 2.4 milligrams (mg) subcutaneous (s.c.) injection once weekly for 52 weeks.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Nutrition Research Centre	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Achieve Body Weight Reduction Greater Than Equal To (=) 10.0 Percentage (%) (Yes/No)	Measured as count of participants.	At week 52
Secondary	Change in Body Weight	Measured in percentage.	Week 0 to week 52
Secondary	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.	Week 0 to week 52
Secondary	Number of Participants Who Achieve Body Weight Reduction = 15.0% (Yes/No)	Measured as count of participants.	At week 52
Secondary	Number of Participants Who Achieve Body Weight Reduction = 20.0% (Yes/No)	Measured as count of participants.	At week 52
Secondary	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.	At week 52
Secondary	Proportion of Days Covered (PDC) by Study Product	Measured in percentage.	Week 0 to week 52
Secondary	Number of Participants Who Are Covered by Study Product = 80% of Days (Yes/No)	Measured as count of participants.	At week 52
Secondary	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.	Week 0 to week 52