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)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 974
- 试验地点
- 4
- 主要终点
- Change from Baseline in office Systolic Blood Pressure (SBP)
研究概览
简要总结
Glucagon-like peptide 1 receptor agonism (GLP-1 RA) is an established therapeutic mechanism for weight management in individuals with obesity or overweight, as well as glycemic control in participants with type 2 diabetes (T2D). In addition to those beneficial effects, clinical trials have also demonstrated that the use of GLP-1 RA in patients with overweight and obesity or with diabetes have shown a significant reduction of blood pressure (BP).
Unlike injectable or orally available peptide GLP-1 RAs approved by regulatory authorities to date, orforglipron is an oral, nonpeptide, small-molecule GLP-1 RA. Orforglipron is being developed as a daily oral adjunct therapy for several indications, including the treatment of T2D, and for weight management in individuals with obesity or overweight. Additionally, it has the potential to provide benefit to participants with hypertension who have obesity or overweight by achieving and maintaining BP control through adherence to effective treatments, which provides a strong rationale for assessing orforglipron to reduce BP and control hypertension in patients with overweight or obesity.
Study J2A-MC-GZPL (GZPL) is a master protocol that will support 2 pivotal, independent studies, J2A-MC-GZL1 (GZL1) and J2A-MC-GZL2 (GZL2). Each study is a multicenter, randomized, parallel-arm, double-blind, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of orforglipron MTD versus placebo in participants with hypertension and obesity or overweight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Has systolic blood pressure (SBP) greater than or equal to 140 mmHg and/or diastolic blood pressure (DBP) greater than or equal to 90 mmHg (if DBP criteria alone is met, SBP must be greater than or equal to 130 mmHg) at screening (Visit 1).
- •Has SBP greater than or equal to 140 mmHg and/or DBP greater than or equal to 90 mmHg (if DBP criteria alone is met, SBP must be greater than or equal to 130 mmHg) at week 0 (Visit 3).
- •Untreated for hypertension, or on stable antihypertensive medications greater than or equal to 30 days prior to Visit
- •Have a body mass index (BMI) greater than or equal to 25 kg/m².
排除标准
- •Has SBP greater than or equal to 170 mmHg and/or DBP greater than or equal to 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.
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
- 1. Change from Baseline in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) SBP(2. Percent Change from Baseline in Body Weight)
研究者
Dr Manish Mistry
Eli Lilly and Company (India) Pvt. Ltd.