A Prospective, Randomized, Multicentric, Open Label, Active Controlled, Parallel Group Study to Compare the Efficacy, Safety and Immunogenicity of Once-Weekly Hetero-Semaglutide with RMP-Semaglutide (WegovyTM, Novo Nordisk) in Adults with Overweight or Obesity.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 258
- 试验地点
- 37
- 主要终点
- Mean percentage reduction in body weight
研究概览
简要总结
This is a Prospective, Randomized, Multicentric, Open Label, Active Controlled, Parallel Group Study to Compare the Efficacy, Safety and Immunogenicity of Once-Weekly Hetero-Semaglutide with RMP-Semaglutide (WegovyTM, Novo Nordisk) in Adults with Overweight or Obesity. A total of 258 patients randomized in 1:1 ratio (i.e., 129 in Hetero-Semaglutide vs 129 in RMP-Semaglutide). who are overweight with BMI greater than or equal to 27 kg per meter square to less than 30 kg per meter square with comorbidities or obese subjects with BMI greater than or equal to 30 kg per meter square with or without comorbidities who will meet all the inclusion criteria and none of the exclusion criteria will be enrolled in this study. Subject will be administered with Hetero-Semaglutide / RMP-Semaglutide (Wegovy, Novo Nordisk), a prefilled pen injector once-weekly (on the same day each week) as subcutaneous injection in abdomen, thigh or upper arm. The initial dose will be 0.25 mg once weekly for the first 4 weeks followed by fixed-dose escalation regimen, with dose escalation every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg per week), until it reaches the maintenance dose (target dose) of 2.4 mg weekly by week 17. Subjects will be instructed to inject the trial product(s) subcutaneously once weekly in the abdomen, thigh, or upper arm. Subjects will also be required to follow dietary restrictions during the study. Total study duration per patient is 30 weeks (maximum), consists of 2 weeks screening period, 24 weeks of treatment period and followed by 4 weeks of post treatment safety follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of either gender, aged greater than or equal to 18 years to less than or equal to 65 years.
- •Body mass index (BMI) greater than or equal to 27 kg per meter square to less than 30 kg per meter square with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidemia, obstructive sleep apnoea, cardiovascular disease or dysglycemia (prediabetes or type 2 diabetes mellitus) OR greater than or equal to 30 kg per meter square with or without comorbidities at screening and randomization
- •For T2DM Subjects at screening: a.
- •T2DM diagnosed greater than or equal to 180 days prior to screening b.
- •T2DM subjects on stable dose on metformin for at least greater than or equal to 90 days prior to screening c.
- •T2DM subjects with HbA1C 8 percentage-10 percentage.
排除标准
- •History of type 1 diabetes mellitus
- •Known/current diabetic retinopathy in patients with type 2 diabetes.
- •Treatment with glucose-lowering agent(s) agents which can result in weight gain (such as insulin, Thiazolidinediones, Sulfonylureas) or weight loss (SLT2i, dual GIP-GLP RA) prescribed for the indication of diabetes mellitus within 90 days before screening.
- •Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening
- •Previous or planned (during the study period) obesity treatment with surgery or a weight loss device.
- •Hamilton Depression Rating Scale (HAM-D) greater than or equal to total item score 10 or greater than or equal to 2 on suicide item on HAM-D -17 item scale at screening.
- •Subjects with the following laboratory abnormalities at screening a.
- •Alanine aminotransferase (ALT) greater than or equal to 3×ULN b.
- •Aspartate aminotransferase (AST) greater than or equal to 3×ULN c.
- •Total bilirubin (TBiL) greater than or equal to3×ULN d.
- •Serum amylase greater than or equal to 3×ULN f.
- •Serum lipase greater than or equal to 3×ULN g.
- •Serum creatinine greater than or equal to 1.5 mg per dL in males or greater than or equal to 1.4 mg per dL in females.
结局指标
主要结局
Mean percentage reduction in body weight
时间窗: Baseline to 24 weeks
次要结局
- Proportion of subjects with body weight reduction of at least 5%(At 12 and 24 weeks)
- Proportion of subjects with body weight reduction greater than or equal to 10%(At 12 and 24 weeks)
- Proportion of subjects with body weight reduction greater than or equal to 15%(At 12 and 24 weeks)
- Mean change in waist circumference (cm)(Baseline to 12 and 24 weeks)
- Mean change in waist hip ratio (WHR)(Baseline to 12 and 24 weeks)
- Mean change in body mass index (BMI) (kg per meter square)(Baseline to 12 and 24 weeks)
- Mean change in systolic blood pressure (SBP) (mmHg) and diastolic blood pressure (DBP) (mmHg)(Baseline to 12 and 24 weeks)
- Mean change in total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, very low-density lipoprotein (VLDL) cholesterol and triglycerides(Screening to 12 and 24 weeks)
- Mean change in glycated hemoglobin (HbA1c) in type 2 diabetes mellitus (T2DM) subjects(Screening to 12 and 24 weeks)
- Mean change in fasting plasma glucose (FPG) and post prandial plasma glucose (PPG) in T2DM subjects(Baseline to 4, 8, 12, 16, 20 and 24 weeks)
- Change in quality of life by short form survey (SF-36) scores(Baseline to 12 and 24 weeks)
- Proportion of subjects with anti-drug antibody ADA) to Semaglutide(Baseline to 12 and 24 weeks)
- Treatment emergent adverse events by monitoring significant clinical signs, symptoms and laboratory abnormalities(All visits)
研究者
Dr Shubhadeep Sinha
Hetero Labs Limited