Overview
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.
Eligibility
Inclusion Criteria:
- 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 1.
- Have a body mass index (BMI) ≥ 25 kg/m².
Exclusion Criteria:
- Has SBP ≥170 mmHg and/or DBP ≥110 mmHg at Visit 1 or at Visit 3.
- 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