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)
Status: Recruiting
Location: See all (92) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arizona
Elite Clinical Studies, LLC
ACTIVE_NOT_RECRUITING
Phoenix
California
Valley Clinical Trials, Inc.
ACTIVE_NOT_RECRUITING
Covina
Valley Clinical Trials, Inc.
ACTIVE_NOT_RECRUITING
Northridge
Connecticut
Chase Medical Research, LLC
ACTIVE_NOT_RECRUITING
Waterbury
Florida
Excel Medical Clinical Trials
ACTIVE_NOT_RECRUITING
Boca Raton
Care Access - Brandon
ACTIVE_NOT_RECRUITING
Brandon
Northeast Research Institute - Downtown Office
ACTIVE_NOT_RECRUITING
Jacksonville
Peace River Cardiovascular Center
RECRUITING
Port Charlotte
Care Access - St. Petersburg
COMPLETED
St. Petersburg
Hawaii
East-West Medical Research Institute
ACTIVE_NOT_RECRUITING
Honolulu
Massachusetts
Lucida Clinical Trials
ACTIVE_NOT_RECRUITING
New Bedford
Maryland
Ascension Saint Agnes Heart Care
ACTIVE_NOT_RECRUITING
Baltimore
Sinai Hospital Of Baltimore
ACTIVE_NOT_RECRUITING
Baltimore
Michigan
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
ACTIVE_NOT_RECRUITING
Troy
Missouri
StudyMetrix Research
ACTIVE_NOT_RECRUITING
City Of Saint Peters
Nevada
Excel Clinical Research, LLC
ACTIVE_NOT_RECRUITING
Las Vegas
Palm Research Center Sunset
ACTIVE_NOT_RECRUITING
Las Vegas
New York
Rochester Clinical Research, LLC
ACTIVE_NOT_RECRUITING
Rochester
Ohio
Remington-Davis, Inc
ACTIVE_NOT_RECRUITING
Columbus
PriMED Clinical Research
ACTIVE_NOT_RECRUITING
Dayton
Oregon
Advanced Research Institute - Tigard
ACTIVE_NOT_RECRUITING
Tigard
South Carolina
Care Access - Mauldin
ACTIVE_NOT_RECRUITING
Mauldin
Texas
Dallas Heart and Vascular Consultants, PA
ACTIVE_NOT_RECRUITING
Duncanville
Texas Institute of Cardiology, PA
ACTIVE_NOT_RECRUITING
Mckinney
North Hills Family Medicine/North Hills Medical Research
ACTIVE_NOT_RECRUITING
North Richland Hills
Utah
Advanced Research Institute
ACTIVE_NOT_RECRUITING
Ogden
Virginia
Carient Heart & Vascular - Manassas
ACTIVE_NOT_RECRUITING
Manassas
Health Research of Hampton Roads, Inc.
ACTIVE_NOT_RECRUITING
Newport News
National Clinical Research, Inc
ACTIVE_NOT_RECRUITING
Richmond
Washington
Eastside Research Associates
ACTIVE_NOT_RECRUITING
Redmond
Other Locations
Argentina
CEMEDIC
RECRUITING
Buenos Aires
CIPREC
RECRUITING
Buenos Aires
CIPREC
RECRUITING
Buenos Aires
Instituto Médico Especializado (IME)
RECRUITING
Buenos Aires
Instituto de Investigaciones Clínicas Córdoba
RECRUITING
Córdoba
Centro de Investigaciones Clínicas Baigorria
RECRUITING
Granadero Baigorria
INECO Neurociencias Oroño
RECRUITING
Rosario
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
RECRUITING
Rosario
Santa Maria de la Salud Centro Medico
RECRUITING
San Isidro
China
Beijing Pinggu District Hospital
ACTIVE_NOT_RECRUITING
Beijing
China-Japan Union Hospital
ACTIVE_NOT_RECRUITING
Changchun
Changde First People's Hospital
ACTIVE_NOT_RECRUITING
Changde
Sichuan Provincial People's Hospital
ACTIVE_NOT_RECRUITING
Chengdu
The Second Affiliated Hospital of Chongqing Medical University - Yuzhong Campus
ACTIVE_NOT_RECRUITING
Chongqing
Jinan Central Hospital
ACTIVE_NOT_RECRUITING
Jinan
Lishui Central Hospital
ACTIVE_NOT_RECRUITING
Lishui
The First Affiliated Hospital of Henan University of Science &Technology
ACTIVE_NOT_RECRUITING
Luoyang Shi
Ruijin Hospital Shanghai Jiaotong University School of Medicine
ACTIVE_NOT_RECRUITING
Shanghai
Siping Central People's Hospital
ACTIVE_NOT_RECRUITING
Siping
Wuxi People's Hospital
ACTIVE_NOT_RECRUITING
Wuxi
Shaanxi provincial people's hospital
ACTIVE_NOT_RECRUITING
Xi'an
Germany
Zentrum für klinische Studien Bad Homburg
RECRUITING
Bad Homburg
FutureMeds GmbH
RECRUITING
Berlin
Zentrum fur klinische Forschung - Köln
RECRUITING
Cologne
Hausärztlich-Kardiologisches MVZ am Felsenkeller GmbH/Zentrum für klinische Studien
RECRUITING
Dresden
Universitaetsklinikum Carl Gustav Carus Dresden
RECRUITING
Dresden
Medizentrum Essen Borbeck
RECRUITING
Essen
AmBeNet GmbH
RECRUITING
Leipzig
Familienmedizinisches Zentrum Radowsky
RECRUITING
Leipzig
RED-Institut GmbH
RECRUITING
Oldenburg
Greece
Athens Medical Center - Psychikon branch
ACTIVE_NOT_RECRUITING
Athens
General Hospital of Athens G. Gennimatas
ACTIVE_NOT_RECRUITING
Athens
University Hospital of Ioannina
ACTIVE_NOT_RECRUITING
Ioannina
AHEPA University General Hospital of Thessaloniki
ACTIVE_NOT_RECRUITING
Thessaloniki
G. Gennimatas General Hospital of Thessaloniki
ACTIVE_NOT_RECRUITING
Thessaloniki
Papageorgiou General Hospital of Thessaloniki
ACTIVE_NOT_RECRUITING
Thessaloniki
India
Life Care Hospital and Research Centre
RECRUITING
Bangalore
All India Institute of Medical Sciences
RECRUITING
Bhubaneswar
G.B. Pant Institute of Postgraduate Medical Education & Research
RECRUITING
New Delhi
Ashirwad Hospital and Research Centre
RECRUITING
Ulhasnagar
Japan
Fukuwa Clinic
ACTIVE_NOT_RECRUITING
Chūōku
Tokyo-Eki Center-building Clinic
ACTIVE_NOT_RECRUITING
Chūōku
Takai Internal Medicine Clinic
ACTIVE_NOT_RECRUITING
Kamakura-shi
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
ACTIVE_NOT_RECRUITING
Matsuyama
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
ACTIVE_NOT_RECRUITING
Yamato-shi
Poland
Uniwersytecki Szpital Kliniczny w Białymstoku
RECRUITING
Bialystok
Centrum Medyczne Hipokrates S.C. Elżbieta I Grzegorz Grześk
RECRUITING
Bydgoszcz
NZOZ Centrum Medyczne KERmed
RECRUITING
Bydgoszcz
IRMED
RECRUITING
Piotrkow Trybunalski
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
RECRUITING
Przemyśl
Private Practice - Dr. Robert Witek
RECRUITING
Tarnów
Balsam Medica
RECRUITING
Warsaw
NZOZ Regionalna Poradnia Diabetologiczna
RECRUITING
Wroclaw
Puerto Rico
Dorado Medical Complex
ACTIVE_NOT_RECRUITING
Dorado
Puerto Rico Medical Research
ACTIVE_NOT_RECRUITING
Ponce
Spain
CHUAC-Complejo Hospitalario Universitario A Coruña
ACTIVE_NOT_RECRUITING
A Coruña
Hospital San Rafael - La Coruña
ACTIVE_NOT_RECRUITING
A Coruña
EAP Sardenya
ACTIVE_NOT_RECRUITING
Barcelona
EAP Osona Sud - Alt Congost S.L.P
ACTIVE_NOT_RECRUITING
Centelles
Complejo Asistencial Universitario de León - Hospital de León
ACTIVE_NOT_RECRUITING
León
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
ACTIVE_NOT_RECRUITING
Seville
Hospital Quiron Infanta Luisa
ACTIVE_NOT_RECRUITING
Seville
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2025-04-30
Estimated Completion Date: 2027-09
Participants
Target number of participants: 974
Treatments
Experimental: Orforglipron (GZL1)
Participants will receive orforglipron orally or placebo.
Experimental: Orforglipron (GZL2)
Participants will receive orforglipron orally or placebo.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company