NCT06948435进行中（未招募）3 期
A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants With Hypertension and Obesity or Overweight: Randomized, Double-Blind, Placebo-Controlled Trials (ATTAIN-HYPERTENSION)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 487
- 试验地点
- 192
- 主要终点
- Change from Baseline in office Systolic Blood Pressure (SBP)
研究概览
简要总结
GZL1 is an independent study conducted under the GZPL master protocol. GZL1 will evaluate the efficacy and safety of orforglipron for treatment of hypertension in participants with obesity or overweight.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •refer to the GZPL master protocol for screening eligibility.
排除标准
- •refer to the GZPL master protocol for screening eligibility.
研究组 & 干预措施
Placebo
Placebo Comparator
Administered placebo.
干预措施: Placebo (Drug)
Orforglipron
Experimental
Participants will receive orforglipron orally.
干预措施: Orforglipron (Drug)
结局指标
主要结局
Change from Baseline in office Systolic Blood Pressure (SBP)
时间窗: Baseline to Week 36
次要结局
- Change from Baseline in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) SBP(Baseline to Week 36)
- Percent Change from Baseline in Body Weight(Baseline to Week 36)
- Percent Change from Baseline in Triglycerides(Baseline to Week 36)
- Percent Change from Baseline in non-HDL Cholesterol(Baseline to Week 36)
- Percent Change from Baseline in hsCRP Concentration (mg/L)(Baseline to Week 48)
- Change in office SBP in Randomized Withdrawal Population(Week 48 to Week 60)
- Pharmacokinetics (PK): Steady-State Area Under the Concentration Curve (AUC) of Orforglipron(Baseline to Week 36)
研究者
研究点 (192)
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