RecruitingPhase 3NCT06948422
A Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening)
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)
Sponsor
Eli Lilly and Company
Enrollment
974 participants
Start Date
Apr 30, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria9
- 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
Interventions
DRUGOrforglipron
Administered orally.
DRUGPlacebo
Administered orally.
Locations(101)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06948422
Related Trials
EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease
NCT070644731153 locations
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
NCT0605963898 locations
OPtimizing Technology to Improve Medication Adherence and BP Control (OPTIMA-BP)
NCT052937561 location
Coaching and Navigation by Community Health Workers (CHWs) Through Telehealth for High-risk Hypertension
NCT074614154 locations
SGLT2i Improve Left Atrial Function in Patients With Paroxysmal Atrial Fibrillation, Hypertension and Abnormal Glucose Metabolism
NCT074820201 location