A Phase 3, Multi-center, Randomized, Double-Blind and Placebo-controlled Study to Evaluate the Efficacy and Safety of XW003 in Adults With Overweight or Obesity (SLIMMER)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 664
- 试验地点
- 1
- 主要终点
- Percent change in body weight from baseline
研究概览
简要总结
The aim of the study is to evaluate the efficacy and safety of XW003 versus placebo in adults with overweight or obesity
详细描述
In this Phase 3 study, eligible participants will be randomized into three cohorts in a 3:1:3:1:3:1 ratio to receive once-weekly subcutaneous XW003 (low, medium, or high dosage) or volume-matching placebo for 48 weeks, including a dose-escalation 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
- Triple (Participant, Care Provider, 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
- •Male or female, 18-75 years old, inclusive;
- •BMI between 24.0 to 28.0 kg/m2 with at least one comorbidity, including prediabetes, hypertension, hyperlipidemia, fatty liver , obstructive sleep apnea syndrome, etc.; or BMI ≥ 28 kg/m2 with or without comorbidities.
- •Weight change of no more than 5% (based on self-report), with diet and exercise alone, within 3 months before screening.
- •Willing and able to maintain stable diet and exercise during the study period.
排除标准
- •Obesity induced by endocrine diseases such as hypothyroidism, Cushing Syndrome, etc.
- •History of bariatric surgery (except liposuction >1 year ago) or planned bariatric surgery during the study period.
- •Within 3 months before screening, history of using the following drugs or treatments:
- •Any approved or unapproved weight-loss drugs or Chinese herbs or health products that affect body weight.
- •Any hypoglycemic medication.
- •Any medication that may cause significant weight gain, including systemic glucocorticoid treatment, tricyclic anti-depressants, anti-epileptic and antipsychotics.
- •Any investigational drug, vaccine, or medical device.
研究组 & 干预措施
C2- XW003 Medium Dosage
XW003 with medium dosage once weekly
干预措施: Ecnoglutide Medium Dosage (Drug)
C1- XW003 Low Dosage
XW003 with low dosage once weekly
干预措施: Ecnoglutide Low Dosage (Drug)
C1-Placebo
Matched Placebo once weekly
干预措施: Placebo (Drug)
C2-Placebo
Matched Placebo once weekly
干预措施: Placebo (Drug)
C3- XW003 High Dosage
XW003 with high dosage once weekly
干预措施: Ecnoglutide High Dosage (Drug)
C3-Placebo
Matched Placebo once weekly
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change in body weight from baseline
时间窗: Week 40
Proportion of subjects with weight loss ≥5% from baseline
时间窗: Week 40
次要结局
- Proportion of subjects with weight loss ≥ 5%, 10%, 15% from baseline(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48)
- Change from baseline in BMI(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48)
- Change from baseline in waist and hip circumferences(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48)
- Percent and absolute body weight change from baseline(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40 and Week 48)