A Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL1

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)

GZL1 is an independent study conducted under the GZPL master protocol. GZL1 will evaluate the efficacy and safety of orforglipron for treatment of hypertension in participants with obesity or overweight.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

487

Phase

  • 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 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 Clínicas 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
      • Port Charlotte, Florida, United States, 33952
        • Peace River Cardiovascular Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East-West Medical Research Institute
    • Maryland
      • 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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • refer to the GZPL master protocol for screening eligibility.

Exclusion Criteria:

  • refer to the GZPL master protocol for screening eligibility.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Orforglipron
Participants will receive orforglipron orally.
Drug: Orforglipron
Administered orally
Other Names:
  • LY3502970
Placebo Comparator: Placebo
Administered placebo.
Drug: Placebo
placebo administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in office Systolic Blood Pressure (SBP)
Time Frame: Baseline to Week 36
Baseline to Week 36

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) SBP
Time Frame: Baseline to Week 36
Baseline to Week 36
Percent Change from Baseline in Body Weight
Time Frame: Baseline to Week 36
Baseline to Week 36
Percent Change from Baseline in Triglycerides
Time Frame: Baseline to Week 36
Baseline to Week 36
Percent Change from Baseline in non-HDL Cholesterol
Time Frame: Baseline to Week 36
Baseline to Week 36
Percent Change from Baseline in hsCRP Concentration (mg/L)
Time Frame: Baseline to Week 48
Baseline to Week 48
Change in office SBP in Randomized Withdrawal Population
Time Frame: Week 48 to Week 60
Week 48 to Week 60
Pharmacokinetics (PK): Steady-State Area Under the Concentration Curve (AUC) of Orforglipron
Time Frame: Baseline to Week 36
Baseline to Week 36

Collaborators and Investigators

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

Sponsor

Eli Lilly and Company

Investigators

  • 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)

April 30, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

April 21, 2025

First Submitted That Met QC Criteria

April 21, 2025

First Posted (Actual)

April 29, 2025

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27359
  • J2A-MC-GZL1 (Other Identifier: Eli Lilly and Company)
  • J2A-MC-GZPL (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

product manufactured in and exported from the U.S.

Yes

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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