Effect and Safety of Semaglutide 2.4 mg Once-weekly on Weight Management in Subjects With Overweight or Obesity.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 34
- 主要终点
- Change From Baseline in Body Weight (Percentage [%])
研究概览
简要总结
This study will look at the change in body weight from the start to the end of the study. The purpose of the study is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the medicine participants will have talks with study staff about healthy food choices, how to be more physically active and what else they can do to lose weight. Participants will either get semaglutide or "dummy medicine" - which treatment 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 skinfold in the stomach, thigh or upper arm.• The study will last for about 1 year. Participants will have 11 clinic visits and 8 phone calls with the study doctor. Participants will have 3 clinic visits where they cannot eat and drink (water is allowed) for up to 8 hours before the visit and 1 clinic visit where they cannot eat and drink for up to 2 hours before the visit. (4 visits and 1 visit, respectively, if they have type 2 diabetes (T2D)). Participants will have 4 clinic visits where they will have blood samples taken. (5 visits if they have T2D). For China: Participants will have 9 clinic visits where they will have blood samples taken. Women cannot take part if pregnant, breast-feeding or planning to become 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
- •Male or female, age 18 years or older at the time of signing informed consent
- •History of at least one self-reported unsuccessful dietary effort to lose body weight
- •For subjects without T2D at screening:
- •Body mass index (BMI) of :
- •greater than or equal to 30 kg/m^2
- •greater than or equal to 27 kg/m^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
- •For subjects with T2D at screening:
- •Diagnosed with T2D above or equal to 180 days prior to the day of 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 medications alone or in any combination (metformin, α-glucosidase inhibitor (AGI), SU, glinides, SGLT2i or glitazone) according to local label
- •HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)
- •BMI greater than or equal to 27 kg/m^2
排除标准
- •A self-reported change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records
- •For subjects without T2D at screening:
- •- HbA1c equal to or above 6.5% (48 mmol/mol) as measured by the central laboratory at screening
- •For subjects with T2D at screening :
- •Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of below 30 mL/min/1.73 m^2 (below 60 mL/min/1.73 m^2 in subjects treated with SGLT2i) according to CKDEPI creatinine equation as defined by KDIGO 2012 by the central laboratory at screening
- •Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed 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.
研究组 & 干预措施
Semaglutide
Once-weekly injections of gradually increased doses of semaglutide
干预措施: Semaglutide (Drug)
Placebo (semaglutide)
Once-weekly injections of gradually increased doses of semaglutide placebo
干预措施: Placebo (semaglutide) (Drug)
结局指标
主要结局
Change From Baseline in Body Weight (Percentage [%])
时间窗: Baseline (week 0), week 44
Change from baseline at week 0 to week 44 in body weight (%) is presented.The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization (week 0) to last trial-related participant-site contact (week 51).
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 5% (Yes/No)
时间窗: At week 44
Number of participants who achieved \>=5% weight reduction at week 44 for in-trial observation period 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. In-trial observation period: the uninterrupted time interval from the start of randomization (week 0) to last trial-related participant-site contact (week 51).
次要结局
- Change From Baseline in Free Fatty Acids-Ratio to Baseline(Baseline (week 0), week 44)
- Change From Baseline in Triglycerides-Ratio to Baseline(Baseline (week 0), week 44)
- Change From Baseline in SF-36 All Domains (Except Physical Functioning) and 2 Component Summary Scores(Baseline (week 0), week 44)
- Change From Baseline in IWQOL-Lite for Physical Domain Score, Psychological Domain Score and Total Score(Baseline (week 0), week 44)
- Number of Participants With Type 2 Diabetes (T2D) Who Achieved HbA1c Less Than (<) 7.0 Percent (%) (53 mmol/Mol)(At week 44)
- Number of Participants Who Achieved Responder Definition Value for SF-36 Physical Functioning Score (Yes/No)(At week 44)
- Number of Participants Who Achieved Responder Definition Value For IWQoL-Lite for CT Physical Function (5-items) Score (Yes/No)(At week 44)
- Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 10% (Yes/No)(At week 44)
- Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 15% (Yes/No)(At week 44)
- Change From Baseline in Waist Circumference(Baseline (week 0), week 44)
- Change From Baseline in Body Weight (Kilogram [kg])(Baseline (week 0), week 44)
- Change From Baseline in Body Mass Index (BMI)(Baseline (week 0), week 44)
- Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 20% (Yes/No)(At week 44)
- Change From Baseline in Systolic Blood Pressure(Baseline (week 0), week 44)
- Change From Baseline in Short Form-36 (SF-36) - Physical Functioning Score(Baseline (week 0), week 44)
- 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 44)
- Change From Baseline in Glycosylated Haemoglobin (HbA1c) (Percentage [%])(Baseline (week 0), week 44)
- Change From Baseline in HbA1c (Millimoles Per Mole [mmol/Mol])(Baseline (week 0), week 44)
- Change From Baseline in Fasting Plasma Glucose (FPG) (Milligrams Per Deciliter [mg/dL])(Baseline (week 0), week 44)
- Change From Baseline in FPG (Millimoles Per Liter [mmol/L])(Baseline (week 0), week 44)
- Change From Baseline in Fasting Serum Insulin: Ratio to Baseline(Baseline (week 0), week 44)
- Change From Baseline in Diastolic Blood Pressure(Baseline (week 0), week 44)
- Change From Baseline in Total Cholesterol: Ratio to Baseline(Baseline (week 0), week 44)
- Change From Baseline in High-Density Lipoproteins (HDL)-Ratio to Baseline(Baseline (week 0), week 44)
- Change From Baseline in Low-Density Lipoproteins (LDL)-Ratio to Baseline(Baseline (week 0), week 44)
- Change From Baseline in Very Low-Density Lipoproteins (VLDL)-Ratio to Baseline(Baseline (week 0), week 44)
- Number of Participants With T2D Who Achieved HbA1c Less Than or Equal to (<=) 6.5% (48 mmol/Mol)(At week 44)
- Change From Baseline in Glycaemic Category (Normo-Glycaemia, Pre-Diabetes, T2D) in Participants With no T2D at Baseline(Baseline (week 0), week 44)
- Change From Baseline in Number of Participants With Antihypertensive Medication (Decrease, No Change, Increase)(Baseline (week 0), week 44)
- Change From Baseline in Number of Participants With Lipid-Lowering Medication (Decrease, No Change, Increase)(Baseline (week 0), week 44)
- Change From Baseline in Number of Participants With Concomitant Oral Antidiabetic Medication (Decrease, No Change, Increase) in Participants With No T2D at Baseline(Baseline (week 0), week 44)
- Change From Baseline in Number of Participants in Fatty Liver Index (FLI) Score Category(Baseline (week 0), week 44)
- Number of Treatment Emergent Adverse Events (TEAEs)(Baseline (week 0), week 51)
- Number of Serious Adverse Events (SAEs)(Baseline (week 0), week 51)
- Number of Participants Who From Randomization Permanently Discontinued Randomized Trial Product(Baseline (week 0), week 44)
- Time to Permanent Discontinuation of Randomized Trial Product (Weeks)(Baseline (week 0), week 44)
- Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes (Yes/No) in Participants With T2D at Week 0(Baseline (week 0), week 51)
- Change From Baseline in Pulse(Baseline (week 0), week 44)
- Change From Baseline in Amylase: Ratio to Baseline(Baseline (week 0), week 44)
- Change From Baseline in Lipase: Ratio to Baseline(Baseline (week 0), week 44)
- Change From Baseline in Calcitonin: Ratio to Baseline(Baseline (week 0), week 44)