A Randomized, Double-blind Placebo-controlled, Parallel-group, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 27
- 主要终点
- Percent Change From Baseline in Body Weight at Week 12
研究概览
简要总结
The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo in severely obese Type 2 Diabetes Mellitus (T2DM) participants after 12 weeks of treatment on: the percentage change in body weight from baseline and safety and tolerability.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index (BMI) greater than or equal to (>=) 35 to less than or equal to (<=) 50 kilogram per meter square (kg/m^2) at screening
- •Stable weight (that is, change of <= 5 percent [%] within 12 weeks before screening based on medical or participant reported history)
- •Hemoglobin A1c of >= 6.5% and <= 9.5% at screening and meets one of the inclusion criteria as: (a) on diet and exercise alone >= 12 weeks prior to screening; (b) on stable dose of single oral antihyperglycemic agent (AHA) or dual-combination oral AHAs for >= 12 weeks prior to screening
- •Women must be either: (a) Postmenopausal, or (b) Permanently sterilized or otherwise be incapable of pregnancy, or (c) Heterosexually active and practicing a highly effective method of birth control, or (d) Not heterosexually active
- •Willing and able to adhere to specific the prohibitions and restrictions
排除标准
- •History of obesity with a known secondary cause (example, Cushing's disease/syndrome)
- •History of Type 1 diabetes mellitus, diabetic ketoacidosis, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- •Fasting C-peptide less than (<) 0.7 nanogram per milliliter (ng/mL) at screening
- •Fasting fingerstick glucose of >= 270 milligram per deciliter (mg/dL) (>=15 millimoles per liter [mmol/L]) on Day 1
- •Ongoing, inadequately controlled thyroid disorder as assessed by the investigator's review of the participant's medical history. Participants taking thyroid hormone replacement therapy must be on stable doses for at least 6 weeks before the screening visit
研究组 & 干预措施
JNJ-64565111 Dose Level 1
Participants will receive JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 12-week treatment phase.
干预措施: JNJ-64565111 Dose Level 1 (Drug)
JNJ-64565111 Dose Level 2
Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly for 12-week treatment phase.
干预措施: JNJ-64565111 Dose Level 2 (Drug)
JNJ-64565111 Dose Level 3
Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly for 12-week treatment phase.
干预措施: JNJ-64565111 Dose Level 3 (Drug)
Placebo
Participants will receive placebo matching to JNJ-64565111 SC once-weekly for 12-week treatment phase.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Body Weight at Week 12
时间窗: Baseline, Week 12
Percent change from baseline in body weight in kilograms (kg) at Week 12 was reported.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to 16 Weeks
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An TEAE is defined as an AE with an onset after the initiation study medication and before the last study medication date of the double-blind (12-Week) treatment phase plus 35 Days.
次要结局
- Change From Baseline in Body Weight at Week 12(Baseline, Week 12)
- Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Weight Loss at Week 12(Week 12)