NCT05890976已完成3 期
Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in Chinese Adults With Overweight or Obesity (OASIS 3)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 15
- 主要终点
- Relative Change in Body Weight
研究概览
简要总结
This study is being conducted to see if semaglutide tablets can be used as a treatment to help people who are above a healthy weight range to lose weight. Semaglutide tablets are a new medicine being tested to treat people living with excess body weight. Participants will either get semaglutide or placebo once daily morning for 44 weeks.
In addition to taking the medicine, participants will have talks with study staff about:
- Healthy food choices
- How to be more physically active
- What participants can do to lose weight This study will last for about 1 year.
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
- •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 28.0 kilogram per meter square (kg/m^2) or
- •greater than or equal to 24.0 kg/m^2 with greater than or equal to 1 weight-related comorbidity (treated or untreated). Weight-related comorbidities should be hypertension, T2D, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.
- •History of at least one self-reported unsuccessful dietary effort to lose body weight.
- •For participants with T2D at screening the following inclusion criteria apply in addition to criteria 1- 4:
- •Diagnosed with T2D greater than or equal to 180 days prior to screening.
- •Treated with either diet and exercise alone or stable treatment (same drug(s) or active ingredient, dose and dosing frequency) for at least 60 days prior to the day of screening with up to 3 oral antidiabetic drugs (OAD)s alone or in any combination (metformin, α-glucosidase (AGI), sulphonylureas (SU), glinides, SGLT2i (sodium-glucose co-transporter 2 inhibitor) or glitazone).
- •HbA1c 7.0 - 10.0 percent (53 - 86 millimoles per mole [mmol/mol]) (both inclusive) as measured by central laboratory at screening.
排除标准
- •Participants without T2D at screening:
- •HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening.
- •History of type 1 or type 2 diabetes.
- •Treatment with glucose-lowering agent(s) within 90 days prior to screening.
- •Participants with T2D at screening:
- •Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- •Renal impairment measured as estimated glomerular filtration rate (eGFR) value of lesser than 30 milli litre per min/1.73 square metre (mL/min/1.73 m^2) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease Improving Global Outcomes (KDIGO) 2012 classification by the central laboratory at screening.
研究组 & 干预措施
Semaglutide 50 mg
Experimental
Participants will receive semaglutide tablets orally once daily. Participants will receive semaglutide in a dose escalation manner for 44 weeks: 3 mg (weeks 0 to 4), 7 mg (weeks 5 to 8), 14 mg (weeks 9 to 12), 25 mg (weeks 13 to 16) and 50 mg (weeks 17 to 44).
干预措施: Semaglutide (Drug)
Semaglutide Placebo
Placebo Comparator
Participants will receive placebo tablets matched to semaglutide orally once daily for 44 weeks.
干预措施: Semaglutide Placebo (Drug)
结局指标
主要结局
Relative Change in Body Weight
时间窗: From baseline (week 0) to end of treatment (week 44)
Measured in percentage (%)
Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 5 Percent
时间窗: At end of treatment (week 44)
Measured as count of participants
次要结局
- Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 10 Percent(At end of treatment (week 44))
- Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 15 Percent(At end of treatment (week 44))
- Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 20 Percent(At end of treatment (week 44))
- Change in Glycated Haemoglobin (HbA1c)(From baseline (week 0) to end of treatment (week 44))
- Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite- CT) - Physical Function Domain(From baseline (week 0) to end of treatment (week 44))
- Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite- CT) - Total score(From baseline (week 0) to end of treatment (week 44))
- Change in Fasting Plasma Glucose(From baseline (week 0) to end of treatment (week 44))
- Change in Impact of Weight on Daily Activities Quesionnaire (IWDAQ) - Total Score(From randomisation (week 0) to end-of-treatment (week 44))
- Change in Body Mass Index (BMI)(From baseline (week 0) to end of treatment (week 44))
- Change in Waist Circumference(From baseline (week 0) to end of treatment (week 44))
- Change in Systolic Blood Pressure(From baseline (week 0) to end of treatment (week 44))
- Change in Diastolic Blood Pressure(From randomisation (week 0) to end of treatment (week 44))
- Change in Fasting Serum Insulin(From baseline (week 0) to end of treatment (week 44))
- Change in Total Cholesterol(From baseline (week 0) to end of treatment (week 44))
- Change in High-density Lipoprotein (HDL) Cholesterol(From baseline (week 0) to end of treatment (week 44))
- Change in Low-density Lipoproteins (LDL) Cholesterol(From baseline (week 0) to end of treatment (week 44))
- Change in Very Low-density Lipoproteins (VLDL) Cholesterol(From baseline (week 0) to end of treatment (week 44))
- Change in Triglycerides(From baseline (week 0) to end of treatment (week 44))
- Change in Free Fatty Acids(From baseline (week 0) to end of treatment (week 44))
- Change in High Sensitivity C-reactive Protein (hsCRP)(From baseline (week 0) to end of treatment (week 44))
- Change in waist-height ratio (WtHR)(From baseline (week 0) to end of treatment (week 44))
- Number of Treatment Emergent Adverse Events(TEAE's)(From baseline (week 0) to end of treatment (week 44))
- Number of Treatment Emergent Serious Adverse Events(TESAE's)(From baseline (week 0) to end of study (week 51))
- AUC 0-24h,sema,50mg,ss: Area Under The Semaglutide-Time Curve (0-24h) During a Dosing Interval at Steady State(Week 20)
- Cmax,sema,50mg,ss: Maximum Concentration at Steady State of Semaglutide 50 mg(Week 20)
研究者
研究点 (15)
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