NCT06948422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
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 974
- 试验地点
- 197
- 主要终点
- Number of Participants Allocated to Each ISA
研究概览
简要总结
The GZPL master protocol will support 2 independent studies, J2A-MC-GZL1 (GZL1) and J2A-MC-GZL2 (GZL2). The purpose of this study is to create a framework to evaluate the safety and efficacy of orforglipron for the 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
- Screening
- 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
- •Has systolic blood pressure (SBP) ≥ 140 mmHg and/or diastolic blood pressure (DBP) ≥ 90 mmHg (if DBP criteria alone is met, SBP must be ≥130 mmHg) at screening (Visit 1).
- •Has SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg (if DBP criteria alone is met, SBP must be ≥130 mmHg) at week 0 (Visit 3).
- •Untreated for hypertension, or on stable antihypertensive medications ≥ 30 days prior to Visit
- •Have a body mass index (BMI) ≥ 25 kg/m².
排除标准
- •Has SBP ≥170 mmHg and/or DBP ≥110 mmHg at Visit 1 or at Visit
- •Has known secondary causes of hypertension
- •Have heart failure with reduced ejection fraction (HFrEF) diagnosis
- •Have had any of the following conditions within 90 days prior to screening.
- •hospitalization for hypertension or for congestive heart failure
- •acute coronary syndrome or acute myocardial infarction, or
- •cerebrovascular accident (stroke).
- •Have type 1 diabetes (T1D)
- •Have acute or chronic hepatitis, including a history of autoimmune hepatitis
研究组 & 干预措施
Orforglipron (GZL2)
Experimental
Participants will receive orforglipron orally or placebo.
干预措施: Placebo (Drug)
Orforglipron (GZL1)
Experimental
Participants will receive orforglipron orally or placebo.
干预措施: Orforglipron (Drug)
Orforglipron (GZL1)
Experimental
Participants will receive orforglipron orally or placebo.
干预措施: Placebo (Drug)
Orforglipron (GZL2)
Experimental
Participants will receive orforglipron orally or placebo.
干预措施: Orforglipron (Drug)
结局指标
主要结局
Number of Participants Allocated to Each ISA
时间窗: Week -8 to Week 0
次要结局
未报告次要终点
研究者
研究点 (197)
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