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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 474
- 试验地点
- 47
- 主要终点
- Percent Change From Baseline in Body Weight at Week 26
研究概览
简要总结
The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo after 26 weeks of treatment on the percent change in body weight from baseline and to assess the safety and tolerability, in non-diabetic severely obese participants.
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 square meter (kg/m^2) at the screening visit
- •Stable weight (that is, change of <= 5 percent [%] within 12 weeks before screening based on medical history)
- •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
- •Woman of childbearing potential have a negative pregnancy test at screening
- •Willing and able to adhere to specific the prohibitions and restrictions
排除标准
- •History of obesity with a known secondary cause (for example, Cushing's disease/syndrome)
- •History of Type 1 diabetes mellitus, Type 2 diabetes mellitus (T2DM), diabetic ketoacidosis (DKA), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- •Has a Hemoglobin A1c (HbA1c) of >= 6.5% or fasting plasma glucose (FPG) >= 126 milligrams per deciliter (mg/dL) (>= 7.0 millimoles per liter [mmol/L]) at screening
- •Screening calcitonin of >= 50 picograms per milliliter (pg/mL) personal history or family history of medullary thyroid cancer, or of multiple endocrine neoplasia syndrome type 2 (MEN 2), regardless of time prior to screening
- •History of glucagonoma
研究组 & 干预措施
Double-Blind: JNJ-64565111 Dose Level 1
Participants will receive a JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 26-week treatment phase.
干预措施: JNJ-64565111 Dose Level 1 (Drug)
Double-Blind: JNJ-64565111 Dose Level 2
Participants will receive a JNJ-64565111 Dose Level 2 SC once-weekly for 26-week treatment phase.
干预措施: JNJ-64565111 Dose Level 2 (Drug)
Double-Blind: JNJ-64565111 Dose Level 3
Participants will receive a JNJ-64565111 Dose Level 3 SC once-weekly for 26-week treatment phase.
干预措施: JNJ-64565111 Dose Level 3 (Drug)
Double-Blind: Placebo
Participants will receive placebo matching to JNJ-64565111 SC once-weekly for 26-week treatment phase.
干预措施: Placebo (Drug)
Open-Label: 3.0 milligram (mg) Liraglutide
Participant will receive once-daily doses of 0.6, 1.2, 1.8, 2.4, or 3.0 mg. The participants will receive liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1. Participants will be instructed to increase the dose of liraglutide by 0.6 mg dose increment every 7 days, up to the full dosage of 3.0 mg by Week 5. Participants will then continue on the 3.0 mg once-daily dosage until Week 26.
干预措施: Liraglutide (Drug)
结局指标
主要结局
Percent Change From Baseline in Body Weight at Week 26
时间窗: Baseline, Week 26
Percent change in body weight in kilograms (kg) from baseline to Week 26 was reported.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to Week 30
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. A TEAE was defined as an AE with an onset after the initiation study drug and before the last study drug date of the double-blind (26-week) treatment phase for plus 28 days for liraglutide participants, and plus 35 days for JNJ-64565111 and placebo participants.
次要结局
- Change From Baseline in Body Weight at Week 26(Baseline, Week 26)
- Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26(Week 26)
- Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26(Week 26)