Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 957
- 试验地点
- 1
- 主要终点
- Relative Change in Body Weight (%)
研究概览
简要总结
This trial is conducted globally. The aim of this trial is to investigate safety and efficacy of once-daily semaglutide in obese subjects without diabetes mellitus.
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
- Double (Participant, Investigator)
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 trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Male or female, age 18 years or older at the time of signing inform consent - Body mass index (BMI) equal or above 30.0 kg/m^2 at the screening visit - At least one unsuccessful weight loss attempt per investigator judgement
排除标准
- •A HbA1c (glycosylated haemoglobin) equal to or above 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus - Treatment with glucose lowering agent(s) within 90 days before screening - Screening calcitonin equal to or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 - History of pancreatitis (acute or chronic) - Obesity induced by endocrine disorders (e.g. Cushing Syndrome) - Treatment with any medication within 90 days before screening that based on investigator's judgement may cause significant weight change - Previous surgical treatment for obesity (liposuction and/or abdominoplasty performed 1 year before screening is allowed) - History of major depressive disorder within 2 years before randomisation - Any lifetime history of a suicidal attempt - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)
研究组 & 干预措施
Sema 0.05 mg
Dose 0.05 mg
干预措施: semaglutide (Drug)
Sema 0.1 mg
Dose 0.05 or 0.1 mg with dose escalation every fourth week
干预措施: semaglutide (Drug)
Sema 0.2 mg
Dose 0.05, 0.1 or 0.2 mg with dose escalation every fourth week
干预措施: semaglutide (Drug)
Sema 0.3 mg
Dose 0.05, 0.1, 0.2 or 0.3 mg with dose escalation every fourth week
干预措施: semaglutide (Drug)
Sema 0.4 mg
Dose 0.05, 0.1, 0.2, 0.3, or 0.4 mg with dose escalation every fourth week
干预措施: semaglutide (Drug)
Sema 0.3 mg (fast dose escalation)
Dose 0.05, 0.1, 0.2 or 0.3 mg with dose escalation every second week
干预措施: semaglutide (Drug)
Sema 0.4 mg (fast dose escalation)
Dose 0.05, 0.1, 0.2, 0.3, or 0.4 mg with dose escalation every second week
干预措施: semaglutide (Drug)
Lira 3.0 mg
Dose 0.6, 1.2, 1.8, 2.4, 3.0 mg with dose escalation every week
干预措施: liraglutide (Drug)
Placebo Sema 0.05 mg
Placebo arm matching active arm Sema 0.05 mg
干预措施: placebo (Drug)
Placebo Sema 0.1 mg
Placebo arm matching active arm Sema 0.1 mg
干预措施: placebo (Drug)
Placebo Sema 0.2 mg
Placebo arm matching active arm Sema 0.2 mg
干预措施: placebo (Drug)
Placebo Sema 0.3 mg
Placebo arm matching active arm Sema 0.3 mg
干预措施: placebo (Drug)
Placebo Sema 0.4 mg
Placebo arm matching active arm Sema 0.4 mg
干预措施: placebo (Drug)
Placebo Sema 0.3 mg (fast dose escalation)
Placebo arm matching active arm Sema 0.3 mg (fast dose escalation)
干预措施: placebo (Drug)
Placebo Sema 0.4 mg (fast dose escalation)
Placebo arm matching active arm Sema 0.4 mg (fast dose escalation)
干预措施: placebo (Drug)
Placebo Lira 3.0 mg
Placebo arm matching active arm Lira 3.0 mg
干预措施: placebo (Drug)
结局指标
主要结局
Relative Change in Body Weight (%)
时间窗: Week 0, Week 52
Relative change from baseline (week 0) in body weight was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site.
次要结局
- Participants With Weight Loss of ≥5% of Baseline Body Weight(Week 52)
- Participants With Weight Loss of ≥10% of Baseline Body Weight(Week 52)
- Change in Body Weight (kg)(Week 0, Week 52)
- Change in Waist Circumference(Week 0, Week 52)
- Change in Waist to Hip Circumference Ratio(Week 0, Week 52)
- Change in BMI(Week 0, Week 52)
- Change in HbA1c(Week 0, Week 52)
- Change in FPG(Week 0, Week 52)
- Change in Glycaemic Category (Normoglycaemia, Pre-diabetes, T2D)(Week 0, Week 52)
- Change in SBP(Week 0, Week 52)
- Change in DBP(Week 0, Week 52)
- Change in Lipids (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides and FFA)(Week 0, Week 52)
- Change in hsCRP(Week 0, Week 52)
- Change in IWQoL Lite(Week 0, Week 52)
- Change in Pulse(Week 0, week 52)
- Change in SF-36(Week 0, Week 52)
- Participants With Change in Concomitant Medications (Antihypertensive and Lipid-lowering Medications)(Week 0, Week 52)
- Compliance With Nutritional Counselling(Week 4-52)
- Number of AEs During the Trial(Week 0-59)
- Number of Hypoglycaemic Episodes During the Trial(Week 0-59)
- Number of New and Ongoing Nausea, Vomiting, Diarrhoea, and Constipation Events by Week(Week 0-59)
- Nausea: Individual Scores of Nausea Questionnaire and Severity by NRS Score(Week 52)
- Change in ECG(Week 0, week 52)
- Change in Haematology: Haemoglobin(Week 0, week 52)
- Change in Haematology: Haematocrit(Week 0, week 52)
- Change in Haematology: Thrombocytes, Leucocytes and Differential Count(Week 0, week 52)
- Change in Haematology: Erythrocytes(Week 0, week 52)
- Change in Biochemistry: Creatinine and Bilirubin (Total)(Week 0, week 52)
- Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP(Week 0, week 52)
- Change in Biochemistry: Urea, Sodium, Potassium and Calcium (Total)(Week 0, week 52)
- Change in Biochemistry: Albumin(Week 0, week 52)
- Change in Biochemistry: Calcitonin(Week 0, week 52)
- Change in Biochemistry: TSH(Week 0, week 52)
- Change in Mental Health Assessed by C-SSRS(Week 0 and Week 4-59)
- Change in Mental Health Assessed by PHQ-9(Week 0, week 52)
- Anti-semaglutide Antibodies During and After Treatment(Week 0-52)