A Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening)

Description

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.

Conditions

Hypertension

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Study Overview

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Study Details

Study 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.

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)

A Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening)

Condition
Hypertension
Intervention / Treatment

-

Contacts and Locations

Phoenix

Elite Clinical Studies, LLC, Phoenix, Arizona, United States, 85018

Covina

Valley Clinical Trials, Inc., Covina, California, United States, 91723

Northridge

Valley Clinical Trials, Inc., Northridge, California, United States, 91325

Waterbury

Chase Medical Research, LLC, Waterbury, Connecticut, United States, 06708

Boca Raton

Excel Medical Clinical Trials, Boca Raton, Florida, United States, 33434

Brandon

Care Access - Brandon, Brandon, Florida, United States, 33510

Jacksonville

Northeast Research Institute - Downtown Office, Jacksonville, Florida, United States, 32204

Port Charlotte

Peace River Cardiovascular Center, Port Charlotte, Florida, United States, 33952

Sun City Center

Care Access - Sun City Center - Cypress Village Boulevard, Sun City Center, Florida, United States, 33573

Honolulu

East-West Medical Research Institute, Honolulu, Hawaii, United States, 96814

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2027-09