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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Number of Participants Who Achieved Greater Than or Equal to (≥) 10.0 Percent (%) Body Weight Reduction (Yes/no)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Semaglutide (Drug)
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.
干预措施: Orlistat (Drug)
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.
干预措施: Phentermine/Topiramate (Drug)
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.
干预措施: Naltrexone/Bupropion (Drug)
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.
干预措施: Liraglutide (Drug)
结局指标
主要结局
Number of Participants Who Achieved Greater Than or Equal to (≥) 10.0 Percent (%) Body Weight Reduction (Yes/no)
时间窗: At end of treatment (week 52)
Number of participants who achieved greater than or equal to 10.0% body weight reduction (yes/no) at week 52 is presented.
次要结局
- Number of Participants Who Achieved Greater Than or Equal to (≥) 15.0% Body Weight Reduction (Yes/no)(At end of treatment (week 52))
- Number of Participants Who Achieved Greater Than or Equal to (≥) 20.0% Body Weight Reduction (Yes/no)(At end of treatment (week 52))
- Number of Participants Who Achieved Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Domain Score Greater Than or Equal to (≥) 14.6 (Yes/no)(At end of treatment (week 52))
- Percentage of Days Covered (PDC) by Study Product(From week 0 to week 52)
- Number of Participants Covered by Study Product Greater Than or Equal to (≥) 80% of Days (Yes/no)(At end of treatment (week 52))
- Change in Work Limitations Questionnaire 25-item Version (WLQ-25), Total Score (TS)(Baseline (week 0), end of treatment (week 52))
- Percentage Change in Body Weight(Baseline (week 0), end of treatment (week 52))
- Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Domain(Baseline (week 0), end of treatment (week 52))