Efficacy and Safety of Oral Semaglutide 25 mg Once Daily in Adults With Overweight or Obesity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 307
- 试验地点
- 43
- 主要终点
- Percentage Change in Body Weight
研究概览
简要总结
This study will look how well semaglutide tablets taken once daily helps people with body weight above the healthy range. Participants will either get semaglutide 25 milligram (mg) once daily or placebo once daily. This study will last for 72 weeks, which includes 1-week screening period, 64 weeks of treatment period and 7 weeks of follow up period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
- •Male or female, age greater than or equal to 18 years at the time of signing informed consent
- •Body mass index (BMI) of
- •Greater than or equal to 27.0 kg/m^2 with the presence of at least one of the following weight-related complications (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular (CV) disease OR
- •Greater than or equal to 30.0 kg/m^2
- •History of at least one self-reported unsuccessful dietary effort to lose body weight
排除标准
- •A self-reported change in body weight greater than 5 kg (11 pound [lbs]) within 90 days before screening irrespective of medical records
- •HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening
研究组 & 干预措施
Oral semaglutide 25 mg
Participants will receive semaglutide tablets orally once daily. Participants will receive semaglutide in a dose escalation manner for 64 weeks: 3 mg (weeks 0 to 4), 7 mg (weeks 5 to 8), 14 mg (weeks 9 to 12), and 25 mg (weeks 13 to 64).
干预措施: Semaglutide (Drug)
Oral semaglutide placebo
Participants will receive placebo tablets matched to semaglutide orally once daily for 64 weeks.
干预措施: Placebo semaglutide (Drug)
结局指标
主要结局
Percentage Change in Body Weight
时间窗: Baseline (week 0), end of treatment (week 64)
Percentage change in body weight from baseline (week 0) to end of treatment (week 64) is presented.
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No)
时间窗: At end of treatment (week 64)
Number of participants who achieved ≥5% body weight reduction at the end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 5% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 5% weight reduction.
次要结局
- Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)(At end of treatment (week 64))
- Number of Participants Who Achieved Body Weight Reduction ≥ 15% (Yes/No)(At end of treatment (week 64))
- Number of Participants Who Achieved Body Weight Reduction ≥ 20% (Yes/No)(At end of treatment (week 64))
- Change in Physical Function Domain (5-items) Score Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite for CT)(Baseline (week 0), end of treatment (week 64))
- Number of Participants Who Achieved ≥14.6 IWQOL-Lite-CT Physical Function Domain (PFD) Score (Yes/No)(Baseline (week 0), end of treatment (week 64))
- Change in Body Weight - Kilogram (kg)(Baseline (week 0), end of treatment (week 64))
- Change in Body Mass Index (BMI)(Baseline (week 0), end of treatment (week 64))
- Change in Waist Circumference(Baseline (week 0), end of treatment (week 64))
- Change in Systolic Blood Pressure(Baseline (week 0), end of treatment (week 64))
- Change in Diastolic Blood Pressure(Randomisation (week 0), end of treatment (week 64))
- Change in Glycosylated Haemoglobin (HbA1c)(Baseline (week 0), end of treatment (week 64))
- Change in Total Cholesterol - Ratio to Baseline(Baseline (week 0), end of treatment (week 64))
- Change in High Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline(Baseline (week 0), end of treatment (week 64))
- Change in Low Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline(Baseline (week 0), end of treatment (week 64))
- Change in Very Low-Density Lipoproteins (VLDL) Cholesterol - Ratio to Baseline(Baseline (week 0), end of treatment (week 64))
- Change in Triglycerides - Ratio to Baseline(Baseline (week 0), end of treatment (week 64))
- Change in Free Fatty Acids - Ratio to Baseline(Baseline (week 0), end of treatment (week 64))
- Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline(Baseline (week 0), end of treatment (week 64))
- Change in Fasting Plasma Glucose (FPG)(Baseline (week 0), end of treatment (week 64))
- Change in Fasting Serum Insulin - Ratio to Baseline(Baseline (week 0), end of treatment (week 64))
- Number of Participants With Body Mass Index (BMI) Less Than (<) 30 at Week 64 (Yes/no)(From baseline (week 0) to end of treatment (week 64))
- Number of Participants With Change in Glycaemic Status(Baseline (week 0), end of treatment (week 64))
- Number of Treatment Emergent Adverse Events (TEAEs)(From baseline (week 0) to end of study (week 71))
- Number of Serious Treatment Emergent Adverse Events(From baseline (week 0) to end of study (week 71))
- Change in Pulse(Baseline (week 0), end of treatment (week 64))