Efficacy and Safety of Semaglutide 2.4 mg Once-weekly in Asians With Obesity Diagnosed as BMI ≥ 25 kg/m2 According to Local Guidelines
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 16
- 主要终点
- Change in Body Weight (%) : In-trial Observation Period
研究概览
简要总结
This study looks at how well semaglutide helps people lose weight. This study will look at the change in the participants' body weight from the start to the end of the study. The study compares the weight loss in people who get semaglutide to the weight loss in people who get placebo. Placebo is a "dummy" medicine that looks like the study medicine, but has no effect on the body.
Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm.
Participants will also have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight.
The study will last for about a year (50 weeks). Participants will have 10 clinic visits and 8 phone calls. At 6 of the clinic visits participants will have blood samples taken.
Participants cannot take part if participants have or have had diabetes. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study 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)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
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
- •Age above or equal to 18 years at the time of signing informed consent.
- •BMI at least 25.0 kg/m^2 at screening.
- •Both parents of Asian descent.
- •History of at least one self-reported unsuccessful dietary effort to lose body weight.
排除标准
- •HbA1c at least 48 mmol/mol (6.5%) as measured by the central laboratory at screening.
- •History of type 1 or type 2 diabetes mellitus.
- •A self-reported change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records.
- •Any participant where a substantial weight loss, in the investigator's opinion, might jeopardise the participant's safety.
- •Renal impairment with estimated Glomerular Filtration Rate (eGFR) below 15 mL/min/1.73 m^2 at screening.
研究组 & 干预措施
Semaglutide 2.4 mg
干预措施: Semaglutide 2.4 mg (Drug)
Placebo
干预措施: Placebo (semaglutide 2.4 mg) (Drug)
结局指标
主要结局
Change in Body Weight (%) : In-trial Observation Period
时间窗: Baseline (week 0), end of treatment (week 44)
Change in percentage (%) of body weight from baseline (week 0) to end of treatment (week 44) is presented in this outcome measure and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial observation period: The time period where the participants were assessed in the study. The in-trial observation period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Change in Body Weight (%) : On-treatment Observation Period
时间窗: Baseline (week 0), end of treatment (week 44)
Change in percentage (%) of body weight from baseline (week 0) to end of treatment (week 44) is presented in this endpoint. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: The time period where participants were treated with trial product. It started from the date of first trial product administration (week 0) to the date of last trial product administration (week 44) including 2 weeks of follow up. It excludes off treatment period which is defined as at least 2 consecutive missed doses.
Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : In-trial Observation Period
时间窗: At week 44
Number of participants who achieved body weight reduction more than or equal to 5 percent is presented at week 44 in this outcome measure and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial observation period: The time period where the participants were assessed in the study. The in-trial observation period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).
Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : On-treatment Observation Period
时间窗: At week 44
Number of participants who achieved body weight reduction more than or equal to 5 percent is presented at week 44 in this endpoint. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: the time period where partici-pants were treated with trial product. It started from the date of first trial product administration (week 0) to the date of last trial product administration (week 44) including 2 weeks of follow up. It excludes off treatment period which is defined as at least 2 consecutive missed doses.
次要结局
- Change in Waist Circumference(Baseline (week 0), end of treatment (week 44))
- Change in Body Mass Index(Baseline (week 0), end of treatment (week 44))
- Change in Systolic Blood Pressure (mmHg)(Baseline (week 0), end of treatment (week 44))
- Change in Total Cholesterol (mmol/L) - Ratio to Baseline(Baseline (week 0), end of treatment (week 44))
- Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline(Baseline (week 0), end of treatment (week 44))
- Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline(Baseline (week 0), end of treatment (week 44))
- Change in Diastolic Blood Pressure(Baseline (week 0), end of treatment (week 44))
- Change in Total Cholesterol (mg/dL) - Ratio to Baseline(Baseline (week 0), end of treatment (week 44))
- Change in Low-density Lipoprotein (LDL) Cholesterol (mg/dL) - Ratio to Baseline(Baseline (week 0), end of treatment (week 44))
- Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline(Baseline (week 0), end of treatment (week 44))
- Change in Triglycerides (mg/dL) - Ratio to Baseline(Baseline (week 0), end of treatment (week 44))
- Change in Triglycerides (mmol/L) - Ratio to Baseline(Baseline (week 0), end of treatment (week 44))
- Change in High-sensitivity C-reactive Protein (hsCRP) (mg/L) - Ratio to Baseline(Baseline (week 0), end of treatment (week 44))
- Change in HbA1c (%)(Baseline (week 0), end of treatment (week 44))
- Change in HbA1c (mmol/Mol)(Baseline (week 0), end of treatment (week 44))
- Number of Participants Achieved ≥ 10% Body Weight Reduction (Yes/no)(At week 44)
- Number of Participants Achieved ≥15% Body Weight Reduction (Yes/no)(At week 44)
- Number of Participants Achieved ≥20% Body Weight Reduction (Yes/no)(At week 44)
- Change in Body Weight (kg)(Baseline (week 0), end of treatment (week 44))