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)
4 other identifiers
interventional
974
11 countries
100
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hypertension
Started Apr 2025
Typical duration for phase_3 hypertension
100 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2025
CompletedFirst Posted
Study publicly available on registry
April 29, 2025
CompletedStudy Start
First participant enrolled
April 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
May 29, 2026
May 1, 2026
2.3 years
April 21, 2025
May 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Allocated to Each ISA
Week -8 to Week 0
Study Arms (2)
Orforglipron (GZL1)
EXPERIMENTALParticipants will receive orforglipron orally or placebo.
Orforglipron (GZL2)
EXPERIMENTALParticipants will receive orforglipron orally or placebo.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (100)
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
Care Access - St. Petersburg
St. Petersburg, Florida, 33710, 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
City of 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
Dallas Heart and Vascular Consultants, PA
Duncanville, Texas, 75137, 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
Instituto Médico Especializado (IME)
Buenos Aires, 1405, Argentina
CIPREC
Buenos Aires, C1061AAS, Argentina
CIPREC
Buenos Aires, C1119ACN, Argentina
CEMEDIC
Buenos Aires, C1407GTN, Argentina
Instituto de Investigaciones Clínicas Córdoba
Córdoba, 5000, Argentina
Centro de Investigaciones Clínicas Baigorria
Granadero Baigorria, 2152, Argentina
INECO Neurociencias Oroño
Rosario, 2000, Argentina
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
Rosario, 2000, Argentina
Santa Maria de la Salud Centro Medico
San Isidro, 1642, Argentina
Beijing Pinggu District Hospital
Beijing, 101200, China
China-Japan Union Hospital
Changchun, 130033, China
Changde First People's Hospital
Changde, 415000, China
Sichuan Provincial People's Hospital
Chengdu, 610072, China
The Second Affiliated Hospital of Chongqing Medical University - Yuzhong Campus
Chongqing, 400010, China
Jinan Central Hospital
Jinan, 250013, China
Lishui Central Hospital
Lishui, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, 471003, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, 200001, China
Siping Central People's Hospital
Siping, 136000, China
Wuxi People's Hospital
Wuxi, 214023, China
Shaanxi provincial people's hospital
Xi'an, 710068, China
Top Moravia Health
Brno, 61500, Czechia
Ordinace Rihackovi, s.r.o.
Brno, 641 00, Czechia
CTC Hodonin s.r.o.
Hodonín, 695 01, Czechia
MUDr. Sarka Drinkova
Ledeč nad Sázavou, 584 01, Czechia
CCR Ostrava s.r.o
Ostrava, 702 00, Czechia
Diahelp s.r.o
Pardubice V, 530 02, Czechia
Clinoxus
Prague, 140 00, Czechia
Angiocentrum Komorany
Prague, 143 00, Czechia
Praglandia s.r.o
Prague, 150 00, Czechia
Zentrum für klinische Studien Bad Homburg
Bad Homburg, 61348, Germany
FutureMeds GmbH
Berlin, 10629, Germany
Zentrum fur klinische Forschung - Köln
Cologne, 51069, Germany
Hausärztlich-Kardiologisches MVZ am Felsenkeller GmbH/Zentrum für klinische Studien
Dresden, 01277, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, 01307, Germany
Medizentrum Essen Borbeck
Essen, 45355, Germany
AmBeNet GmbH
Leipzig, 04107, Germany
Familienmedizinisches Zentrum Radowsky
Leipzig, 04179, Germany
RED-Institut GmbH
Oldenburg, 23758, Germany
Athens Medical Center - Psychikon branch
Athens, 115 25, Greece
General Hospital of Athens "G. Gennimatas"
Athens, 11527, Greece
University Hospital of Ioannina
Ioannina, 45500, Greece
G. Gennimatas General Hospital of Thessaloniki
Thessaloniki, 546 35, Greece
AHEPA University General Hospital of Thessaloniki
Thessaloniki, 546 36, Greece
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, 56403, Greece
Life Care Hospital and Research Centre
Bangalore, 560092, India
All India Institute of Medical Sciences
Bhubaneswar, 751019, India
G.B. Pant Institute of Postgraduate Medical Education & Research
New Delhi, 110002, India
Ashirwad Hospital and Research Centre
Ulhasnagar, 421004, India
Tokyo-Eki Center-building Clinic
Chūōku, 103-0027, Japan
Fukuwa Clinic
Chūōku, 104-0031, Japan
Takai Internal Medicine Clinic
Kamakura-shi, 247-0056, Japan
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
Matsuyama, 7900034, Japan
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
Yamato-shi, 242-0004, Japan
Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok, 15-276, Poland
Centrum Medyczne "Hipokrates" S.C. Elżbieta I Grzegorz Grześk
Bydgoszcz, 85-092, Poland
NZOZ Centrum Medyczne KERmed
Bydgoszcz, 85-231, Poland
IRMED
Piotrkow Trybunalski, 97-300, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
Przemyśl, 37-700, Poland
Private Practice - Dr. Robert Witek
Tarnów, 33-100, Poland
Balsam Medica
Warsaw, 01-249, Poland
NZOZ Regionalna Poradnia Diabetologiczna
Wroclaw, 50-127, Poland
Dorado Medical Complex
Dorado, 00646, Puerto Rico
Puerto Rico Medical Research
Ponce, 00717, Puerto Rico
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, 15001, Spain
Hospital San Rafael - La Coruña
A Coruña, 15006, Spain
EAP Sardenya
Barcelona, 08025, Spain
EAP Osona Sud - Alt Congost S.L.P
Centelles, 08540, Spain
Complejo Asistencial Universitario de León - Hospital de León
León, 24071, Spain
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
Seville, 41003, Spain
Hospital Quiron Infanta Luisa
Seville, 41010, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2025
First Posted
April 29, 2025
Study Start
April 30, 2025
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
May 29, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.