EUCTR2017-003616-39-PL进行中（未招募）1 期
A Randomized, Double-blind Placebo-controlled and Open-label Active-controlled, Parallel-group, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 440
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Male or female
- •2. 18 to 70 years of age, inclusive
- •3. BMI = 35 to = 50 kg/m2 at the screening visit
- •4. Stable weight (ie, change of = 5% within 12 weeks before screening based on medical history)
- •5. Subjects must have 100% compliance with the open-label placebo run-in medication
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. History of Type 1 or Type II Diabetes mellitus
- •2. Screening calcitonin of = 50 pg/mL (= 50 ng/L)
- •3. A myocardial infarction (MI), unstable angina, revascularization procedure, or cerebrovascular accident within 12 weeks before screening
- •4. Heart failure of New York Heart Association (NYHA) Class II-IV cardiac disease
- •5. History of acute or chronic pancreatitis
研究者
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