NCT07230119进行中（未招募）3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Study to Evaluate the Efficacy and Safety of Zovaglutide in Adults With Overweight or Obesity.
Beijing QL Biopharmaceutical Co.,Ltd49 个研究点 分布在 1 个国家目标入组 755 人开始时间: 2026年1月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 755
- 试验地点
- 49
- 主要终点
- Change in body weight(%)
研究概览
简要总结
This study will evaluate the percentage change in body weight from baseline and proportion of subjects achieving ≥ 5% weight loss from baseline after 52 weeks of treatment with Zovaglutide in subjects with overweight/obesity.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Male or female subjects aged≥18years and≤75 years at the time of signing the ICF.
- •2.At screening and prior to randomization, BMI must meet one of the following criteria:
- •BMI≥28kg/m²regardless of comorbidities；
- •BM≤24 kg/m² and<28 kg/m², with at least one of the following comorbidities: prediabetes, hypertension, dyslipidemia, fatty liver disease, obstructive sleep apnea syndrome due to overweight, or weight-bearing joint pain.
- •3.Weight change due to diet and exercise alone within 3 months prior to screening and randomization did not exceed 5%.
排除标准
- •1.Previously diagnosed obesity caused by monogenic mutations, other diseases, or medications.
- •2.Previous diagnosis of diabetes; or HbA1c ≥ 6.5% or fasting blood glucose ≥ 7.0 mmol/L at screening.
- •3.Used of medicines or treatments that affect weight within 3 months prior to screening.
- •4.History of acute or chronic pancreatitis, or pancreatic injury.
- •5.History of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia (MEN2) in personal or family history.
- •6.History of depression/anxiety disorder, or prior diagnosis of moderate-to-severe anxiety/depressive state, or history of severe psychiatric disorders;
- •7. PHQ-9 scale score is ≥ 15 at screening;
- •8. Screening C-SSRS questionnaire suicide ideation response of "Category 4 or 5," or any "yes" response to suicidal behavior questions.
研究组 & 干预措施
Placebo
Placebo Comparator
Administered subcutaneously (SC), Q4W
干预措施: Placebo (Drug)
Zovaglutide dose 1
Experimental
administered subcutaneously (SC), Q4W
干预措施: Zovaglutide dose 1 (Drug)
Zovaglutide dose 2
Experimental
administered subcutaneously (SC), Q4W
干预措施: Zovaglutide dose 2 (Drug)
结局指标
主要结局
Change in body weight(%)
时间窗: baseline (week 0) to week 52
Proportion of subjects achieving ≥ 5% weight loss
时间窗: 52 weeks
Change in body weight(%)
时间窗: baseline (week 0) to week 52
Proportion of subjects achieving ≥ 5% weight loss
时间窗: 52 weeks
次要结局
- Proportion of subjects achieving ≥10% weight loss(week 52)
- Proportion of subjects achieving ≥15% weight loss.(week 52)
- Proportion of subjects achieving ≥20% weight loss.(week 52)
- Change in body weight (kg)(Baseline (week 0) to week 52)
- Change in BMI (kg/m²)(Baseline (week 0) to week 52)
- Change in waist circumference (cm)(Baseline (week 0) to week 52)
- Change in hip circumference (cm)(Baseline (week 0) to week 52)
- Number of Treatment Emergent Adverse Events (TEAEs)(Baseline (week 0) to week 56)
- Number of Serious Adverse Events (SAEs)(Baseline (week 0) to week 56)
- Positive rate of anti-drug antibodies (ADA).(Baseline (week 0) to week 56)
- Positive rate of neutralizing antibodies (Nab)(Baseline (week 0) to week 56)
- Proportion of subjects achieving ≥10% weight loss(week 52)
- Proportion of subjects achieving ≥15% weight loss.(week 52)
- Proportion of subjects achieving ≥20% weight loss.(week 52)
- Change in body weight (kg)(Baseline (week 0) to week 52)
- Change in BMI (kg/m²)(Baseline (week 0) to week 52)
- Change in waist circumference (cm)(Baseline (week 0) to week 52)
- Change in hip circumference (cm)(Baseline (week 0) to week 52)
- Number of Treatment Emergent Adverse Events (TEAEs)(Baseline (week 0) to week 56)
- Number of Serious Adverse Events (SAEs)(Baseline (week 0) to week 56)
- Positive rate of anti-drug antibodies (ADA).(Baseline (week 0) to week 56)
- Positive rate of neutralizing antibodies (Nab)(Baseline (week 0) to week 56)
研究者
研究点 (49)
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