A Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening) (J2A-MC-GZPL)
Not yet recruiting
- Conditions
- Hypertension
- Registration Number
- jRCT2031250164
- Lead Sponsor
- Eli Lilly Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 974
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
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method - Number of Participants Allocated to Each ISA [ Time Frame: Week -8 to Week 0
- Secondary Outcome Measures
Name Time Method