A Randomized, Double-Blind, Placebo-controlled Study of Efsubaglutide Alfa on Weight Management in Subjects With Overweight or Obesity to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics, and Efficacy.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Weight
研究概览
简要总结
This is a study to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of Efsubaglutide Alfa at difference dose range once-weekly in patients with Overweight or Obesity.
详细描述
This study will look at the adverse events and the change in participants' body weight from the start of the study to the end. Weight loss in participants taking Efsubaglutide Alfa will be compared to weight loss in participants taking placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully understood the study, signed the informed consent.
- •Male or female patients aged from 18 to 75 years at the time of signing informed consent.
- •Body mass index (BMI) greater than or equal to 28 kg/sqm or greater than or equal to 24 kg/sqm with the presence of at least one of the following weight-related comorbidities: prediabetic state, hypertension, dyslipidemia, non-alcoholic steatohepatitis (NASH), obstructive sleep apnea or cardiovascular disease.
- •A self-reported change in body weight less than 5% within 90 days before screening irrespective.
排除标准
- •Glycated hemoglobin (HbA1c) greater than or equal to 6.5%, or previously diagnosed with type 1 diabetes or type 2 diabetes.
- •Have history of clinically significant abnormal gastric emptying, severe chronic gastrointestinal diseases, long-term use of medications that directly affect gastrointestinal peristalsis, or gastrointestinal surgery within 6 months prior to screening, and deemed unsuitable for participation by the investigator.
- •Have history of hyperthyroidism or hypothyroidism, or a thyroid-stimulating hormone (TSH) level below the lower limit or above 1.5 times the upper limit of the normal range.
- •Calcitonin greater than or equal to 50 ng/L, or have history of medullary thyroid carcinoma, multiple endocrine neoplasia (MEN) type 2A or 2B syndrome, or a related family history.
- •Any other condition that, in the judgment of the researchers, may affect the patient's ability to provide informed consent or comply with the trial protocol.
研究组 & 干预措施
Efsubaglutide Alfa 5mg
10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 4 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 5 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.
干预措施: Efsubaglutide Alfa (Biological)
Efsubaglutide Alfa 5mg
10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 4 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 5 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.
干预措施: Placebo (Other)
Efsubaglutide Alfa 7.5mg
10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 4 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 7.5 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.
干预措施: Efsubaglutide Alfa (Biological)
Efsubaglutide Alfa 7.5mg
10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 4 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 7.5 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.
干预措施: Placebo (Other)
Efsubaglutide Alfa 10mg
10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 6 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 10 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.
干预措施: Efsubaglutide Alfa (Biological)
Efsubaglutide Alfa 10mg
10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 6 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 10 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.
干预措施: Placebo (Other)
Efsubaglutide Alfa 15mg
10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 8 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 10 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.
干预措施: Efsubaglutide Alfa (Biological)
Efsubaglutide Alfa 15mg
10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 8 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 10 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.
干预措施: Placebo (Other)
Efsubaglutide Alfa 20mg
10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa orPlacebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 12 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 10 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.
干预措施: Efsubaglutide Alfa (Biological)
Efsubaglutide Alfa 20mg
10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa orPlacebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 12 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 10 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.
干预措施: Placebo (Other)
结局指标
主要结局
Weight
时间窗: Baseline, 4 weeks after the target dose
Relative Change in Body Weight (%), Proportion of subjects with a weight loss of ≥5% from baseline
Adverse Event
时间窗: Adverse events occurring within 4 weeks of the last dose from baseline
Numbers of Adverse Event
次要结局
- Weight(Baseline, 4 weeks after the target dose)
- BMI(Baseline, 4 weeks after the target dose)
- Waist circumference(Baseline, 4 weeks after the target dose)
- Hip circumference(Baseline, 4 weeks after the target dose)
- Waist Hip Rate (WHR)(Baseline, 4 weeks after the target dose)
- Diastolic pressure(Baseline, 4 weeks after the target dose)
- Systolic pressure(Baseline, 4 weeks after the target dose)
- Triglyceride(Baseline, 4 weeks after the target dose)
- Total Cholesterol(Baseline, 4 weeks after the target dose)
- High Density Lipoprotein Cholesterol （HDL-C）(Baseline, 4 weeks after the target dose)
- Low-Density Lipoprotein Cholesterol （LDL-C）(Baseline, 4 weeks after the target dose)
- HbA1c(Baseline, 4 weeks after the target dose)
- Fasting Blood Insulin(Baseline, 4 weeks after the target dose)
- HOMA-IR(Baseline, 4 weeks after the target dose)
- Body Fat(Baseline, 4 weeks after the target dose)