Clinical trial NCT05579249: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-10-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Number of Participants Who Achieve Body Weight Reduction Greater Than Equal To (≥) 10.0 Percentage (%) (Yes/No)
timeFrame: At week 52
Secondary outcomes:
measure: Change in Body Weight
timeFrame: Week 0 to week 52
measure: Change in Impact of Weight on Quality of Life-Lite For Clinical Trials (IWQOL-Lite-CT) Physical Function Domain
timeFrame: Week 0 to week 52
measure: Number of Participants Who Achieve Body Weight Reduction ≥ 15.0% (Yes/No)
timeFrame: At week 52
measure: Number of Participants Who Achieve Body Weight Reduction ≥ 20.0% (Yes/No)
timeFrame: At week 52
measure: Number of Participants Who Achieve Change in IWQOL-Lite For CT Physical Function Domain Score Greater Than (>) 14.6 (Yes/No)
timeFrame: At week 52
measure: Proportion of Days Covered (PDC) by Study Product
timeFrame: Week 0 to week 52
measure: Number of Participants Who Are Covered by Study Product ≥ 80% of Days (Yes/No)
timeFrame: At week 52
measure: Change in Work Limitations Questionnaire 25-item Version (WLQ-25), Total Score
timeFrame: Week 0 to week 52
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Nutrition Research Centre
state: California
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: