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

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Novo Nordisk

Status and phase

Completed
Phase 4

Conditions

Obesity

Treatments

Drug: Semaglutide
Drug: Phentermine/Topiramate
Drug: Orlistat
Drug: Naltrexone/Bupropion
Drug: Liraglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT05579249
U1111-1263-7301 (Other Identifier)
NN9536-4741

Details and patient eligibility

About

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).

Enrollment

500 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

500 participants in 2 patient groups

Semaglutide
Experimental group
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.
Treatment:
Drug: Semaglutide
Other anti-obesity medication
Active Comparator group
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.
Treatment:
Drug: Liraglutide
Drug: Naltrexone/Bupropion
Drug: Phentermine/Topiramate
Drug: Orlistat

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Novo Nordisk

Data sourced from clinicaltrials.gov

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