A Multicenter, Randomized, Double-Blind Study to Compare the Effects of VI-0521,Phentermine, and Placebo on Ambulatory Blood Pressure in Overweight or Obese Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- VIVUS LLC
- 入组人数
- 565
- 试验地点
- 2
- 主要终点
- Change From Baseline to Week 8 in Mean Systolic Blood Pressure as Measured by 24-hr ABPM
研究概览
简要总结
The study is being conducted to evaluate the effect of VI-0521 (Qsymia®) on blood pressure as measured by 24-hour ambulatory blood pressure monitoring, compared to both placebo and an active control (phentermine 30 mg).
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overweight/obese adult males/females 18-75 years of age with a BMI ≥ 27 kg/m2;
- •At least 1 weight-related comorbidity (i.e., hypertension, dyslipidemia, Type 2 diabetes mellitus [T2DM] or prediabetes, or obstructive sleep apnea).
- •Must be ambulatory, willing, and able to wear ABPM monitor apparatus for 24 hours at beginning and end of study.
排除标准
- •Screening blood pressure of > 140/90 mmHg;
- •Type 1 diabetes; T2DM treated with SFUs, GLP-1 receptor agonists, SGLT inhibitors; or not on stable diabetic medications for at least 3 months prior to randomization;
- •Clinically significant cardiac, hepatic, renal, pulmonary, or thyroid disease;
- •History of bipolar disorder, psychosis, greater than one lifetime episode of major depressive disorder, or presence or history of suicidal behavior or suicidal ideation with intent to act;
- •History of glaucoma;
- •Night shift workers;
- •Obesity of known genetic or endocrine origin; recent history of weight instability, or recent participation in a formal weight loss program within 3 months prior to screening; and
- •Smoking cessation within 3 months prior to screening;
- •Use of antihypertensive medications, antidiabetic medications, statins or other lipid lowering agents, or CPAP therapy that has not been stable for at least 3 months prior to randomization;
- •COVID-19 vaccination or treatment for severe COVID-19 infection within a month prior to randomization.
研究组 & 干预措施
VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)
Week 1: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Week 2: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily; Week 3: VI-0521 (Phentermine 11.25 mg + Topiramate 69 mg) oral capsule, once daily; Weeks 4-8: VI-0521 (Phentermine 15 mg + Topiramate 92 mg) oral capsule, once daily
干预措施: VI-0521 (Drug)
Phentermine 30mg
Weeks 1-8: Phentermine 30mg oral capsule, once daily
干预措施: Phentermine (Drug)
Placebo
Weeks 1-8: Placebo oral capsule, once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 8 in Mean Systolic Blood Pressure as Measured by 24-hr ABPM
时间窗: Baseline to Week 8
The change between systolic blood pressure measured at Week 8 relative to the baseline measurements from the ABPM data read out. Blood pressure and heart rate were measured every 20 minutes from 6:00 to 22:00 hours, and every 30 minutes from 22:01 to 5:59 hours for 24 consecutive hours, while subjects continue normal routine activities.
次要结局
- Mean Change in Systolic and Diastolic Blood Pressure From Baseline to Week 8 as Measured in Clinic(Baseline to Week 8)
- Change From Baseline to Week 8 in Mean Diastolic Blood Pressure as Measured by 24-hr ABPM(Baseline to Week 8)