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)
Eli Lilly and Company
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugOrforglipron
Administered orally.
- DrugPlacebo
Administered orally.
Locations (100)
- Elite Clinical Studies, LLCPhoenix, Arizona
- Valley Clinical Trials, Inc.Covina, California
- Valley Clinical Trials, Inc.Northridge, California
- Chase Medical Research, LLCWaterbury, Connecticut
- Excel Medical Clinical TrialsBoca Raton, Florida
- Care Access - BrandonBrandon, Florida