A Multicenter, Randomized, Open-Label, Controlled, Method-of-Use Study Assessing the Effect of Naltrexone Sustained Release (SR)/Bupropion SR on Body Weight and Cardiovascular Risk Factors in Overweight and Obese Subjects (The Ignite Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 12
- 主要终点
- Percent Change in Body Weight From Baseline (Day 1) to Week 26
研究概览
简要总结
The purpose of this Phase 3b study is to assess the effects of combination therapy with naltrexone SR/bupropion SR (NB) used in conjunction with a comprehensive lifestyle intervention (CLI) and in a manner consistent with its intended use after marketing approval, on body weight and cardiovascular risk factors compared to the effects of Usual Care in subjects who are overweight with dyslipidemia and/or controlled hypertension or obese. Subjects in the NB and CLI group are required to undergo an evaluation to continue treatment at Week 16. Subjects are to be discontinued from full participation if they do not lose at least 5% of their body weight relative to baseline and/or are experiencing sustained increases in blood pressure (systolic or diastolic) of ≥10 mmHg above baseline. At Week 26, subjects originally assigned to Usual Care switch to treatment with NB and CLI, and subjects assigned to NB and CLI continue treatment for the duration of the study (78-weeks treatment period).
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male, 18 to 60 years old
- •Body mass index (BMI) ≥30 kg/m2 and ≤45 kg/m2 for subjects with uncomplicated obesity, or BMI ≥27 kg/m2 and ≤45 kg/m2 for subjects with dyslipidemia and/or controlled hypertension
排除标准
- •History of type 1 or type 2 diabetes mellitus diagnosis
- •Myocardial infarction within 6 months prior to screening
- •Angina pectoris Grade III or IV as per the Canadian Cardiovascular Society grading scheme
- •Clinical history of large vessel cortical strokes, including ischemic and hemorrhagic strokes (i.e., transient ischemic attack is not exclusionary)
- •History (within the last 20 years) of seizures, cranial trauma, bulimia, anorexia nervosa, or other conditions that predispose subjects to seizures
- •Past or planned surgical or device intervention (e.g., gastric banding) for obesity
- •Chronic use or positive screen for opioids
- •Regular use of tobacco products
研究组 & 干预措施
NB + CLI
Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with comprehensive lifestyle intervention (CLI)
干预措施: NB (Drug)
NB + CLI
Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with comprehensive lifestyle intervention (CLI)
干预措施: CLI (Behavioral)
Usual Care
Usual Care (self-directed lifestyle intervention)
Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Percent Change in Body Weight From Baseline (Day 1) to Week 26
时间窗: Baseline to Week 26
次要结局
- Change in Waist Circumference From Baseline to Week 26(Baseline to Week 26)
- Change in Fasting High-density Lipoprotein Cholesterol From Baseline to Week 26(Baseline to Week 26)
- Percentage of Subjects Achieving a Loss of at Least 5% of Baseline Body Weight at Week 26(Baseline to Week 26)
- Percentage of Subjects Achieving a Loss of at Least 10% of Baseline Body Weight at Week 26(Baseline to Week 26)
- Percentage of Subjects Achieving a Loss of at Least 15% of Baseline Body Weight at Week 26(Baseline to Week 26)
- Change in Fasting Low-density Lipoprotein Cholesterol From Baseline to Week 26(Baseline to Week 26)
- Change in Systolic Blood Pressure From Baseline to Week 26(Baseline to Week 26)
- Change in Diastolic Blood Pressure From Baseline to Week 26(Baseline to Week 26)
- Change in Fasting Plasma Glucose From Baseline to Week 26(Baseline to Week 26)
- Change in Heart Rate From Baseline to Week 26(Baseline to Week 26)
- Change in Homeostasis Model Assessment-insulin Resistance (HOMA-IR) From Baseline to Week 26(Baseline to Week 26)
- Change in Fasting Triglycerides From Baseline to Week 26(Baseline to Week 26)
- Change Fasting Insulin From Baseline to Week 26(Baseline to Week 26)
- Change in Patient-reported Binge Eating Scale (BES) Total Scores From Baseline to Week 26(Baseline to Week 26)
- Change in Patient-reported Arizona Sexual Experiences Scale (ASEX) Total Scores From Baseline to Week 26(Baseline to Week 26)
- Absolute Change in Body Weight From Baseline to Week 26(Baseline to Week 26)
- Change in Patient-reported Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) Total Score From Baseline to Week 26(Baseline to Week 26)