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

May 28, 2026 updated by: Eli Lilly and Company

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
974

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1405
        • Instituto Médico Especializado (IME)
      • Buenos Aires, Argentina, C1119ACN
        • CIPREC
      • Buenos Aires, Argentina, C1407GTN
        • CEMEDIC
      • Buenos Aires, Argentina, C1061AAS
        • CIPREC
      • Córdoba, Argentina, 5000
        • Instituto de Investigaciones Clínicas Córdoba
      • Granadero Baigorria, Argentina, 2152
        • Centro de Investigaciones Clinicas Baigorria
      • Rosario, Argentina, 2000
        • INECO Neurociencias Oroño
      • Rosario, Argentina, 2000
        • Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
      • San Isidro, Argentina, 1642
        • Santa Maria de la Salud Centro Medico
  • China
      • Beijing, China, 101200
        • Beijing Pinggu District Hospital
      • Changchun, China, 130033
        • China-Japan Union Hospital
      • Changde, China, 415000
        • Changde First People's Hospital
      • Chengdu, China, 610072
        • Sichuan Provincial People's Hospital
      • Chongqing, China, 400010
        • The Second Affiliated Hospital of Chongqing Medical University - Yuzhong Campus
      • Jinan, China, 250013
        • Jinan Central Hospital
      • Lishui, China
        • Lishui Central Hospital
      • Luoyang Shi, China, 471003
        • The First Affiliated Hospital of Henan University of Science &Technology
      • Shanghai, China, 200001
        • Ruijin Hospital Shanghai Jiaotong University School of Medicine
      • Siping, China, 136000
        • Siping Central People's Hospital
      • Wuxi, China, 214023
        • Wuxi People's Hospital
      • Xi'an, China, 710068
        • Shaanxi Provincial People's Hospital
  • Czechia
      • Brno, Czechia, 61500
        • Top Moravia Health
      • Brno, Czechia, 641 00
        • Ordinace Rihackovi, s.r.o.
      • Hodonín, Czechia, 695 01
        • CTC Hodonin s.r.o.
      • Ledeč nad Sázavou, Czechia, 584 01
        • MUDr. Sarka Drinkova
      • Ostrava, Czechia, 702 00
        • CCR Ostrava s.r.o
      • Pardubice V, Czechia, 530 02
        • Diahelp s.r.o
      • Prague, Czechia, 150 00
        • Praglandia s.r.o
      • Prague, Czechia, 143 00
        • Angiocentrum Komorany
      • Prague, Czechia, 140 00
        • Clinoxus
  • Germany
      • Bad Homburg, Germany, 61348
        • Zentrum für Klinische Studien Bad Homburg
      • Berlin, Germany, 10629
        • FutureMeds GmbH
      • Cologne, Germany, 51069
        • Zentrum fur klinische Forschung - Köln
      • Dresden, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus Dresden
      • Dresden, Germany, 01277
        • Hausärztlich-Kardiologisches MVZ am Felsenkeller GmbH/Zentrum für klinische Studien
      • Essen, Germany, 45355
        • Medizentrum Essen Borbeck
      • Leipzig, Germany, 04107
        • AmBeNet GmbH
      • Leipzig, Germany, 04179
        • Familienmedizinisches Zentrum Radowsky
      • Oldenburg, Germany, 23758
        • Red-Institut GmbH
  • Greece
      • Athens, Greece, 11527
        • General Hospital of Athens "G. Gennimatas"
      • Athens, Greece, 115 25
        • Athens Medical Center - Psychikon branch
      • Ioannina, Greece, 45500
        • University Hospital of Ioannina
      • Thessaloniki, Greece, 56403
        • Papageorgiou General Hospital of Thessaloniki
      • Thessaloniki, Greece, 546 36
        • AHEPA University General Hospital of Thessaloniki
      • Thessaloniki, Greece, 546 35
        • G. Gennimatas General Hospital of Thessaloniki
  • India
      • Bangalore, India, 560092
        • Life Care Hospital and Research Centre
      • Bhubaneswar, India, 751019
        • All India Institute of Medical Sciences
      • New Delhi, India, 110002
        • G.B. Pant Institute of Postgraduate Medical Education & Research
      • Ulhasnagar, India, 421004
        • Ashirwad Hospital and Research Centre
  • Japan
      • Chūōku, Japan, 103-0027
        • Tokyo-Eki Center-building Clinic
      • Chūōku, Japan, 104-0031
        • Fukuwa Clinic
      • Kamakura-shi, Japan, 247-0056
        • Takai Internal Medicine Clinic
      • Matsuyama, Japan, 7900034
        • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
      • Yamato-shi, Japan, 242-0004
        • Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
  • Poland
      • Bialystok, Poland, 15-276
        • Uniwersytecki Szpital Kliniczny w Białymstoku
      • Bydgoszcz, Poland, 85-231
        • NZOZ Centrum Medyczne KERmed
      • Bydgoszcz, Poland, 85-092
        • Centrum Medyczne "Hipokrates" S.C. Elżbieta I Grzegorz Grześk
      • Piotrkow Trybunalski, Poland, 97-300
        • IRMED
      • Przemyśl, Poland, 37-700
        • Wojewodzki Szpital Im. SW. Ojca Pio W Przemyslu
      • Tarnów, Poland, 33-100
        • Private Practice - Dr. Robert Witek
      • Warsaw, Poland, 01-249
        • Balsam Medica
      • Wroclaw, Poland, 50-127
        • NZOZ Regionalna Poradnia Diabetologiczna
  • Puerto Rico
      • Dorado, Puerto Rico, 00646
        • Dorado Medical Complex
      • Ponce, Puerto Rico, 00717
        • Puerto Rico Medical Research
  • Spain
      • A Coruña, Spain, 15006
        • Hospital San Rafael - La Coruña
      • A Coruña, Spain, 15001
        • CHUAC-Complejo Hospitalario Universitario A Coruña
      • Barcelona, Spain, 08025
        • EAP Sardenya
      • Centelles, Spain, 08540
        • EAP Osona Sud - Alt Congost S.L.P
      • León, Spain, 24071
        • Complejo Asistencial Universitario de León - Hospital de León
      • Seville, Spain, 41003
        • Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
      • Seville, Spain, 41010
        • Hospital Quiron Infanta Luisa
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Elite Clinical Studies, LLC
    • California
      • Covina, California, United States, 91723
        • Valley Clinical Trials, Inc.
      • Northridge, California, United States, 91325
        • Valley Clinical Trials, Inc.
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research, LLC
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Excel Medical Clinical Trials
      • Brandon, Florida, United States, 33510
        • Care Access - Brandon
      • Jacksonville, Florida, United States, 32204
        • Northeast Research Institute - Downtown Office
      • St. Petersburg, Florida, United States, 33710
        • Care Access - St. Petersburg
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East-West Medical Research Institute
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • Sinai Hospital of Baltimore
      • Baltimore, Maryland, United States, 21229
        • Ascension Saint Agnes Heart Care
    • Massachusetts
      • New Bedford, Massachusetts, United States, 02740
        • Lucida Clinical Trials
    • Michigan
      • Troy, Michigan, United States, 48098
        • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
    • Missouri
      • City of Saint Peters, Missouri, United States, 63303
        • StudyMetrix Research
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Palm Research Center Sunset
      • Las Vegas, Nevada, United States, 89109
        • Excel Clinical Research, LLC
    • New York
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, LLC
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Remington-Davis, Inc
      • Dayton, Ohio, United States, 45429
        • PriMed Clinical Research
    • Oregon
      • Tigard, Oregon, United States, 97223
        • Advanced Research Institute - Tigard
    • South Carolina
      • Mauldin, South Carolina, United States, 29662
        • Care Access - Mauldin
    • Texas
      • Duncanville, Texas, United States, 75137
        • Dallas Heart and Vascular Consultants, PA
      • McKinney, Texas, United States, 75071
        • Texas Institute of Cardiology, PA
      • North Richland Hills, Texas, United States, 76180
        • North Hills Family Medicine/North Hills Medical Research
    • Utah
      • Ogden, Utah, United States, 84405
        • Advanced Research Institute
    • Virginia
      • Manassas, Virginia, United States, 20109
        • Carient Heart & Vascular - Manassas
      • Newport News, Virginia, United States, 23606
        • Health Research of Hampton Roads, Inc.
      • Richmond, Virginia, United States, 23294
        • National Clinical Research, Inc
    • Washington
      • Redmond, Washington, United States, 98052
        • Eastside Research Associates

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Orforglipron (GZL1)
Participants will receive orforglipron orally or placebo.
Drug: Placebo
Administered orally.
Drug: Orforglipron
Administered orally.
Other Names:
  • LY3502970
Experimental: Orforglipron (GZL2)
Participants will receive orforglipron orally or placebo.
Drug: Placebo
Administered orally.
Drug: Orforglipron
Administered orally.
Other Names:
  • LY3502970

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Participants Allocated to Each ISA
Time Frame: Week -8 to Week 0
Week -8 to Week 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 27223
  • J2A-MC-GZL1 (Other Identifier: Eli Lilly and Company)
  • J2A-MC-GZPL (Other Identifier: Eli Lilly and Company)
  • J2A-MC-GZL2 (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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