A Multicenter, Double-blind, Randomized, Parallel-group, Pilot Study of 12-week Duration to Assess the Short-term Safety and Tolerability of Lorcaserin Plus Two Doses of Immediate-Release Phentermine-HCl Compared With Lorcaserin Alone in Overweight and Obese Adults
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 344
- 试验地点
- 13
- 主要终点
- Percentage of Participants Reporting at Least One of Nine Adverse Events (AEs) of Main Interests That May Related to Serotonergic Reaction
研究概览
简要总结
APD356-A001-402 is a multicenter, double-blind, randomized, parallel-group pilot study of 12-week duration in overweight and obese adults. Approximately 225 subjects will be randomized to one of three treatment arms in a ratio 1:1:1 and will receive the combinations of lorcaserin 10 mg twice daily (BID) plus immediate-release phentermine-HCl 15 mg BID or 15 mg once daily (QD), or lorcaserin alone.
详细描述
All subjects will take lorcaserin and phentermine-HCl/placebo once in the morning and again in the mid-afternoon. The dosing is timed to help reduce potential insomnia due to phentermine. Subjects in Arm A will take one tablet twice daily of lorcaserin 10 mg in combination with one capsule twice daily of phentermine placebo. Subjects in Arm B will take one tablet twice daily of lorcaserin 10 mg, one capsule of phentermine-HCl 15 mg once daily in the morning, and one capsule of phentermine placebo once daily in the mid-afternoon. Subjects in Arm C will take one tablet twice daily of lorcaserin 10 mg in combination with one capsule twice daily of phentermine-HCl 15 mg. Subjects will be instructed to take lorcaserin tablets and phentermine/placebo capsules concurrently and attempt to remain on a consistent daily schedule. The study will recruit obese (body mass index [BMI] greater than or equal to 30 kg/m2) subjects with or without a weight-related comorbid condition (e.g., hypertension, dyslipidemia, or sleep apnea) or overweight (BMI greater than or equal to 27 to 29.9 kg/m2) subjects with at least one weight-related co-morbid condition. At least one third of the subjects will have a BMI of 40 kg/m2 or greater, because there is a high likelihood that this combination therapy will be used by these subjects in medical practice.
A lifestyle intervention program, using a 12-week adaptation of the Arena Healthy Lifestyles Program, including diet and exercise counseling, will be implemented for obesity/overweight.
Blood sampling will be performed to evaluate the pharmacokinetics (PK) of lorcaserin and phentermine using population PK modeling as well as the potential relationships between exposure to the lorcaserin/phentermine and measures of safety and change from baseline in body weight, using population PK/PD (pharmacodynamics) modeling.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A
lorcaserin + phentermine placebo
干预措施: lorcaserin + phentermine placebo (Drug)
B
lorcaserin + phentermine-HCl + phentermine placebo
干预措施: lorcaserin + phentermine-HCl + phentermine placebo (Drug)
C
lorcaserin + phentermine-HCl
干预措施: lorcaserin + phentermine-HCl (Drug)
结局指标
主要结局
Percentage of Participants Reporting at Least One of Nine Adverse Events (AEs) of Main Interests That May Related to Serotonergic Reaction
时间窗: Baseline up to Week 12 (end of treatment)
The nine common serotonergic AEs were headache, dizziness, nausea, fatigue, dry mouth, diarrhea, vomiting, insomnia, and/or anxiety.
次要结局
- Number of Participants With Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE) and AEs Leading to Study Drug Discontinuation(Baseline up to Week 16)
- Number of Participants With Treatment-Emergent Markedly Abnormal Laboratory Values(Baseline up to Week 16)
- Percent Change From Baseline in Body Weight at Weeks 1, 2, 4, 8, and 12(Baseline, Weeks 1, 2, 4, 8 and 12)
- Percentage of Participants Who Achieved Greater Than or Equal to (>=) 5 Percent (%) Weight Reduction at Week 12(Week 12 (end of treatment))
- Change From Baseline in Waist Circumference and Hip Circumference at Week 12(Baseline and Week 12 (end of treatment))
- Mean Change From Baseline in Body Weight at Weeks 1, 2, 4, 8, and 12(Baseline, Weeks 1, 2, 4, 8 and 12)
- Change From Baseline in Waist to Hip Circumference Ratio at Week 12(Baseline and Week 12 (end of treatment))