RECRUITING

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

Talk to us

Conditions

Hypertension

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2025-04-30
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06948422

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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).
  2. * 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).
  3. * Untreated for hypertension, or on stable antihypertensive medications ≥ 30 days prior to Visit 1.
  4. * Have a body mass index (BMI) ≥ 25 kg/m².
  1. * Has SBP ≥170 mmHg and/or DBP ≥110 mmHg at Visit 1 or at Visit 3.
  2. * Has known secondary causes of hypertension
  3. * Have heart failure with reduced ejection fraction (HFrEF) diagnosis
  4. * Have had any of the following conditions within 90 days prior to screening.
  5. * hospitalization for hypertension or for congestive heart failure
  6. * acute coronary syndrome or acute myocardial infarction, or
  7. * cerebrovascular accident (stroke).
  8. * Have type 1 diabetes (T1D)
  9. * Have acute or chronic hepatitis, including a history of autoimmune hepatitis

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
1-317-615-4559
clinical_inquiry_hub@lilly.com

Principal Investigator

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 Locations (Sites)

Elite Clinical Studies, LLC
Phoenix, Arizona, 85018
United States
Valley Clinical Trials, Inc.
Covina, California, 91723
United States
Valley Clinical Trials, Inc.
Northridge, California, 91325
United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
United States
Excel Medical Clinical Trials
Boca Raton, Florida, 33434
United States
Care Access - Brandon
Brandon, Florida, 33510
United States
Northeast Research Institute - Downtown Office
Jacksonville, Florida, 32204
United States
Peace River Cardiovascular Center
Port Charlotte, Florida, 33952
United States
Care Access - Sun City Center - Cypress Village Boulevard
Sun City Center, Florida, 33573
United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814
United States
Sinai Hospital Of Baltimore
Baltimore, Maryland, 21209
United States
Ascension Saint Agnes Heart Care
Baltimore, Maryland, 21229
United States
Lucida Clinical Trials
New Bedford, Massachusetts, 02740
United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098
United States
StudyMetrix Research
Saint Peters, Missouri, 63303
United States
Excel Clinical Research, LLC
Las Vegas, Nevada, 89109
United States
Palm Research Center Sunset
Las Vegas, Nevada, 89148
United States
Rochester Clinical Research, LLC
Rochester, New York, 14609
United States
Remington-Davis, Inc
Columbus, Ohio, 43215
United States
PriMED Clinical Research
Dayton, Ohio, 45429
United States
Advanced Research Institute - Tigard
Tigard, Oregon, 97223
United States
Care Access - Mauldin
Mauldin, South Carolina, 29662
United States
Texas Institute of Cardiology, PA
McKinney, Texas, 75071
United States
North Hills Family Medicine/North Hills Medical Research
North Richland Hills, Texas, 76180
United States
Advanced Research Institute
Ogden, Utah, 84405
United States
Carient Heart & Vascular - Manassas
Manassas, Virginia, 20109
United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606
United States
National Clinical Research, Inc
Richmond, Virginia, 23294
United States
Eastside Research Associates
Redmond, Washington, 98052
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-30
Study Completion Date2027-09

Study Record Updates

Study Start Date2025-04-30
Study Completion Date2027-09

Terms related to this study

Additional Relevant MeSH Terms

  • Hypertension