NCT07311850进行中（未招募）3 期
Evaluating The Efficacy and Safety of MET097, a Fully-Biased, Ultra Long-Acting GLP-1RA, In People With Overweight or Obesity: A Phase 3, Multi-Center Randomized, Controlled Trial (VESPER-4)
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
- Pfizer
- 入组人数
- 3,578
- 试验地点
- 177
- 主要终点
- Percent change from baseline in body weight
研究概览
简要总结
This study investigates the efficacy and safety of once weekly injectable MET097 in adult participants with obesity or overweight with weight-related comorbidities excluding T2D. This trial will last for a duration of 84 weeks. The primary endpoint will be assessed after 64 weeks of treatment with the secondary at 84 weeks.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≥ 30 kg/m2 or BMI ≥ 27.0 kg/m2 to <30.0 kg/m2 and presence of at least 1 of the following weight- related comorbidities: Hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease)
排除标准
- •Have any form of diabetes
- •Have a self-reported body weight change > 5 kg (11 pounds) within 3 months prior to Screening
- •Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- •History of chronic pancreatitis or presence of acute pancreatitis within the past 180 days prior to the Screening visit; or active/current, symptomatic gallbladder disease
研究组 & 干预措施
MET097 Dose 2
Experimental
Participants will receive MET097 administered subcutaneously
干预措施: MET097 (Drug)
MET097 Dose 1
Experimental
Participants will receive MET097 administered subcutaneously
干预措施: MET097 (Drug)
MET097 Dose 3
Experimental
Participants will receive MET097 administered subcutaneously
干预措施: MET097 (Drug)
Placebo
Placebo Comparator
Once-weekly placebo administered via subcutaneous injection
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change from baseline in body weight
时间窗: Baseline (Day 0) to Week 64
次要结局
- Percentage of Participants who achieve ≥20% of reduction from baseline body weight(Baseline (Day 0) to Week 64)
- Percentage of Participants who achieve ≥10% of reduction from baseline body weight(Baseline (Day 0) to Week 64)
- Percentage of Participants who achieve ≥5% of reduction from baseline body weight(Baseline (Day 0) to Week 64)
- Percentage of Participants who achieve ≥15% of reduction from baseline body weight(Baseline (Day 0) to Week 64)
- Change from baseline in non-high-density lipoprotein-cholesterol (non-HDL-C) (mg/dL)(Baseline (Day 0) to Week 64)
- Change from baseline in Fasting triglycerides(Baseline (Day 0) to Week 64)
- Change from baseline in systolic blood pressure (mmHg)(Baseline (Day 0) to Week 64)
- Mean change from baseline in body weight(Baseline (Day 0) to Week 84)
- Change from baseline in the Short Form 36 health survey (SF-36) physical function domain score(Baseline (Day 0) to Week 64)
研究者
研究点 (177)
Loading locations...
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