A Phase IV, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Determine the Safety and Efficacy of VI-0521 in Obese Adolescents
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- VIVUS LLC
- 入组人数
- 223
- 试验地点
- 1
- 主要终点
- Mean % Change in Body Mass Index (BMI)
研究概览
简要总结
This study is being conducted to assess weight loss efficacy, as determined by changes in body mass index (BMI), and safety of VI-0521 (Qsymia®) or placebo, taken for 56 weeks accompanied by a lifestyle modification program in obese adolescents age 12-16 years.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 12 years and < 17 years;
- •BMI ≥ the 95th percentile, with documented history of failure to lose sufficient weight or failure to maintain weight loss in a lifestyle modification program;
- •If female, must be using adequate contraception, defined as double barrier methods, stable hormonal contraception plus single barrier method, tubal ligation, or abstinence.
排除标准
- •Type 1 diabetes;
- •Congenital heart disease; clinically significant ECG abnormality;
- •Clinically significant physical exam, vital signs, or laboratory abnormality; clinically significant hepatic or renal disease;
- •Estimated Glomerular Filtration Rate (GFR; Schwartz formula) < 60 mL/minute;
- •Clinically significant thyroid dysfunction as evidenced by signs, symptoms, or thyroid stimulating hormone (TSH) > 1.5 x Upper Limit of Normal;
- •Obesity of known genetic or endocrine origin;
- •History of bipolar disorder or psychosis, depression of moderate or greater severity, or presence or history of suicidal behavior or active suicidal ideation;
- •Recent weight instability, or prior bariatric surgery;
- •History of glaucoma or increased intraocular pressure;
- •Current smoker or smoking cessation within 3 months of screening;
- •Currently taking or plan on taking any of following medications during the study:
- •Anticonvulsants used for treatment of seizure disorder, including barbiturates, benzodiazepines, gamma-aminobutyric acid (GABA) analogues, hydantoins, phenyltriazines, succinimides, and other agents (valproic acid and its derivatives, carbamazepine and its derivatives, zonisamide, and felbamate);
- •Tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), lithium, levodopa, and dopamine receptor agonists;
- •Carbonic anhydrase inhibitors;
- •Insulin, Sulfonylureas (SFUs), glucagon-like peptide -1 (GLP-1) agonists, sodium glucose transporter-1 (SGLT-1), and SGLT-2 inhibitors;
- •Chronic systemic steroids (i.e. glucocorticoids, anabolic steroids) other than oral contraceptives;
- •Treatment for hyperactivity disorder; or
- •Over the counter, prescription medications, herbal agents and dietary supplements used with the intention to lose body weight.
研究组 & 干预措施
VI-0521 Mid Dose (Phentermine 7.5 mg +Topiramate 46 mg)
Weeks 1-2: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Weeks 3-56: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily
干预措施: VI-0521 oral capsule (Drug)
VI-0521 Mid Dose (Phentermine 7.5 mg +Topiramate 46 mg)
Weeks 1-2: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Weeks 3-56: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily
干预措施: Lifestyle Modification (Behavioral)
VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)
Weeks 1-2: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Weeks 3-12: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily; Weeks 13-14: VI-0521 (Phentermine 11.25 mg + Topiramate 69 mg) oral capsule, once daily; Weeks 15-56: VI-0521 (Phentermine 15 mg + Topiramate 92 mg) oral capsule, once daily
干预措施: VI-0521 oral capsule (Drug)
VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)
Weeks 1-2: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Weeks 3-12: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily; Weeks 13-14: VI-0521 (Phentermine 11.25 mg + Topiramate 69 mg) oral capsule, once daily; Weeks 15-56: VI-0521 (Phentermine 15 mg + Topiramate 92 mg) oral capsule, once daily
干预措施: Lifestyle Modification (Behavioral)
Placebo
Subjects will receive placebo oral capsule, once daily for up to 56 weeks
干预措施: Placebo oral capsule (Drug)
Placebo
Subjects will receive placebo oral capsule, once daily for up to 56 weeks
干预措施: Lifestyle Modification (Behavioral)
结局指标
主要结局
Mean % Change in Body Mass Index (BMI)
时间窗: Baseline to Week 56
Mean % change in BMI from Baseline to Week 56
次要结局
- Percent Change in HDL-C From Baseline to Week 56(Baseline, Week 56)
- Change From Baseline in Systolic Blood Pressure at Week 56(Baseline, Week 56)
- Percentage of Subjects Achieving at Least 5% BMI Reduction at Week 56(Baseline to Week 56)
- Percentage of Subjects Achieving at Least 10% BMI Reduction at Week 56(Baseline to Week 56)
- Percentage of Subjects Achieving at Least 15% BMI Reduction at Week 56(Baseline to Week 56)
- Change in Waist Circumference at Week 56(Baseline, Week 56)
- Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda) at Week 56(Baseline, Week 56)
- Change in Fasting Insulin at Week 56(Baseline, Week 56)
- Percent Change in Triglycerides From Baseline to Week 56(Baseline, Week 56)
- Change From Baseline in Diastolic Blood Pressure at Week 56(Baseline, Week 56)