Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in East Asian Participants With Overweight or Obesity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 15
- 主要终点
- Percent Change From Baseline in Body Weight
研究概览
简要总结
Novo Nordisk are doing this study to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight.
This study will look at the change in participants' body weight. Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body). For a fair comparison, people are divided into two groups at random by a computer. This process is called randomisation.
Semaglutide tablets are new medicine being tested to treat overweight and obesity. Doctors in many countries can already prescribe semaglutide tablets at lower doses to treat type 2 diabetes.
Participants will get semaglutide or placebo tablets for 68 weeks and will need to take 1 tablet every morning.
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 The study will last for about 1½ year. Participants will have 14 clinic visits and 7 phone calls with the study healthcare professional.
Blood samples will be taken at 12 visits. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period. If participants are a woman and are able to become pregnant, participants will be checked for pregnancy via urine tests.
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
- •Participants are eligible to be included in the study only if all the following criteria apply:
- •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 above 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 greater than or equal to 2 weight related comorbidities (treated or untreated) according to the JASSO guideline or BMI greater than or equal to 35.0 kg/m^2 with greater than or equal to1 weight related comorbidity (treated or untreated) according to the JASSO guideline. At least one comorbidity should be hypertension, dyslipidaemia or type 2 diabetes (T2D)
- •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), dose and dosing frequency) for at least 60 days prior to the day of screening with up to 3 oral antidiabetic drugs (OADs) alone or in any combination (metformin, α-glucosidase (AGI), sulphonylureas (SU), glinides, SGLT2i (sodium-glucose co-transporter 2 inhibitor) or thiazolidinediones)
- •HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) as measured by central laboratory at screening
排除标准
- •Participants without T2D only:
- •HbA1c greater than or equal to 6.5% (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
- •Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR brlow 15 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
- •Participants with T2D at screening only:
- •Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria within the past 60 days prior to screening
- •Receipt of any other anti-diabetic investigational drug within 90 days prior to screening for this study, or receipt of any investigational drugs not affecting diabetes within 30 days prior to screening for this study
- •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 eGFR value of below 30 mL/min/1.73 m^2 according to CKD EPI creatinine equation as defined by KDIGO 2012 classification by the central laboratory at screening
- •In participants treated with SGLT2i, renal impairment measured as eGFR value of below 60 mL/min/1.73 m^2 according to CKD EPI creatinine equation as defined by KDIGO 2012 classification by the central laboratory at screening
- •The following criteria apply to all participants:
- •Obesity-related:
- •Treatment with any medication indicated for weight management within 90 days prior to screening
- •Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed greater than 1 year prior to screening, (2) lap banding, if the band has been removed greater than 1 year prior to screening, (3) intragastric balloon, if the balloon has been removed greater than 1 year prior to screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed greater than 1 year prior to screening
- •Uncontrolled thyroid disease per investigators discretion
- •A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
研究组 & 干预措施
oral semaglutide placebo once daily
All participants will get semaglutide or placebo tablets, 1 tablet every morning.
干预措施: placebo (semaglutide) (Drug)
oral semaglutide 50 mg once daily
All participants will get semaglutide or placebo tablets, 1 tablet every morning.
干预措施: semaglutide 50 mg (Drug)
结局指标
主要结局
Percent Change From Baseline in Body Weight
时间窗: Baseline (week 0), week 68
Percent change in body weight from baseline (week 0) to week 68 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site.
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 5% (Yes/No)
时间窗: At week 68
Number of participants who achieved \>=5% weight reduction at week 68 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. The outcome measure was evaluated based on the data from in-trial observation period. In-trial: the uninterrupted time interval from the date of randomisation (week 0) to the date of last contact with the study site.
次要结局
- Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 10% (Yes/No)(At week 68)
- Change From Baseline in Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite for CT) - Physical Function Domain (5-items) Score(Baseline (week 0), week 68)
- Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 15% (Yes/No)(At week 68)
- Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 20% (Yes/No)(At week 68)
- Change From Baseline in Body Mass Index (BMI)(Baseline (week 0), week 68)
- Change From Baseline in Waist Circumference Measured According to the JASSO (Japan Society for the Study of Obesity) Guideline(Baseline (week 0), week 68)
- Change From Baseline in Visceral Fat Area (VFA) Measured by CT Scan in a Subset of the Japanese Study Population (%)(Baseline (week 0), week 68)
- Change From Baseline in Visceral Fat Area (VFA) Measured by CT Scan in a Subset of the Japanese Study Population (Centimeter Square [cm^2])(Baseline (week 0), week 68)
- Change From Baseline in Systolic Blood Pressure(Baseline (week 0), week 68)
- Change From Baseline in Diastolic Blood Pressure(Baseline (week 0), week 68)
- Change From Baseline in Glycosylated Haemoglobin (HbA1c)(Baseline (week 0), week 68)
- Change From Baseline in Total Cholesterol: Ratio to Baseline(Baseline (week 0), week 68)
- Change From Baseline in High-Density Lipoproteins (HDL): Ratio to Baseline(Baseline (week 0), week 68)
- Change From Baseline in Low-Density Lipoproteins (LDL): Ratio to Baseline(Baseline (week 0), week 68)
- Change From Baseline in Very Low-Density Lipoproteins (VLDL): Ratio to Baseline(Baseline (week 0), week 68)
- Change From Baseline in Triglycerides: Ratio to Baseline(Baseline (week 0), week 68)
- Change From Baseline in Free Fatty Acids: Ratio to Baseline(Baseline (week 0), week 68)
- Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) : Ratio to Baseline(Baseline (week 0), week 68)
- Number of Treatment Emergent Adverse Events (TEAEs)(Week 0 to week 75)
- Number of Serious Adverse Events (SAEs)(Week 0 to week 75)