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

Janssen-Cilag International NV0 个研究点目标入组 440 人开始时间: 2018年3月15日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•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

•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

发起方