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HypertensionPhase 3NCT06948422

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

A Phase 3 study testing Orforglipron in people with Hypertension, run by Eli Lilly and Company at 100 sites in 11 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension
What is being tested?
Orforglipron
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
974 participants
Where
100 sitesin 11 countries
Study dates
30 Apr 2025to Sep 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • cerebrovascular accident (stroke).
  • Have type 1 diabetes (T1D)
  • Have acute or chronic hepatitis, including a history of autoimmune hepatitis

Trial locations and contacts

100 sites in 11 countries.

100 sites in 11 countries

United States29 sites

  • Sinai Hospital Of Baltimore

    Baltimore, Maryland, 21209

  • Ascension Saint Agnes Heart Care

    Baltimore, Maryland, 21229

  • Excel Medical Clinical Trials

    Boca Raton, Florida, 33434

  • Care Access - Brandon

    Brandon, Florida, 33510

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303

  • Remington-Davis, Inc

    Columbus, Ohio, 43215

  • Valley Clinical Trials, Inc.

    Covina, California, 91723

  • PriMED Clinical Research

    Dayton, Ohio, 45429

  • Dallas Heart and Vascular Consultants, PA

    Duncanville, Texas, 75137

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814

  • Northeast Research Institute - Downtown Office

    Jacksonville, Florida, 32204

  • Excel Clinical Research, LLC

    Las Vegas, Nevada, 89109

  • Palm Research Center Sunset

    Las Vegas, Nevada, 89148

  • Carient Heart & Vascular - Manassas

    Manassas, Virginia, 20109

  • Care Access - Mauldin

    Mauldin, South Carolina, 29662

  • Texas Institute of Cardiology, PA

    McKinney, Texas, 75071

  • Lucida Clinical Trials

    New Bedford, Massachusetts, 02740

  • Health Research of Hampton Roads, Inc.

    Newport News, Virginia, 23606

  • North Hills Family Medicine/North Hills Medical Research

    North Richland Hills, Texas, 76180

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • Advanced Research Institute

    Ogden, Utah, 84405

  • Elite Clinical Studies, LLC

    Phoenix, Arizona, 85018

  • Eastside Research Associates

    Redmond, Washington, 98052

  • National Clinical Research, Inc

    Richmond, Virginia, 23294

  • Rochester Clinical Research, LLC

    Rochester, New York, 14609

  • Care Access - St. Petersburg

    St. Petersburg, Florida, 33710

  • Advanced Research Institute - Tigard

    Tigard, Oregon, 97223

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan, 48098

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

Other trials in United States

China12 sites

  • Beijing Pinggu District Hospital

    Beijing, 101200

  • China-Japan Union Hospital

    Changchun, 130033

  • Changde First People's Hospital

    Changde, 415000

  • Sichuan Provincial People's Hospital

    Chengdu, 610072

  • The Second Affiliated Hospital of Chongqing Medical University - Yuzhong Campus

    Chongqing, 400010

  • Jinan Central Hospital

    Jinan, 250013

  • Lishui Central Hospital

    Lishui

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang Shi, 471003

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, 200001

  • Siping Central People's Hospital

    Siping, 136000

  • Wuxi People's Hospital

    Wuxi, 214023

  • Shaanxi provincial people's hospital

    Xi'an, 710068

Other trials in China

Argentina9 sites

  • Instituto Médico Especializado (IME)

    Buenos Aires, 1405

  • CIPREC

    Buenos Aires, C1061AAS

  • CIPREC

    Buenos Aires, C1119ACN

  • CEMEDIC

    Buenos Aires, C1407GTN

  • Instituto de Investigaciones Clínicas Córdoba

    Córdoba, 5000

  • Centro de Investigaciones Clínicas Baigorria

    Granadero Baigorria, 2152

  • INECO Neurociencias Oroño

    Rosario, 2000

  • Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica

    Rosario, 2000

  • Santa Maria de la Salud Centro Medico

    San Isidro, 1642

Other trials in Argentina

Czechia9 sites

  • Top Moravia Health

    Brno, 61500

  • Ordinace Rihackovi, s.r.o.

    Brno, 641 00

  • CTC Hodonin s.r.o.

    Hodonín, 695 01

  • MUDr. Sarka Drinkova

    Ledeč nad Sázavou, 584 01

  • CCR Ostrava s.r.o

    Ostrava, 702 00

  • Diahelp s.r.o

    Pardubice V, 530 02

  • Clinoxus

    Prague, 140 00

  • Angiocentrum Komorany

    Prague, 143 00

  • Praglandia s.r.o

    Prague, 150 00

Other trials in Czechia

Germany9 sites

  • Zentrum für klinische Studien Bad Homburg

    Bad Homburg, 61348

  • FutureMeds GmbH

    Berlin, 10629

  • Zentrum fur klinische Forschung - Köln

    Cologne, 51069

  • Hausärztlich-Kardiologisches MVZ am Felsenkeller GmbH/Zentrum für klinische Studien

    Dresden, 01277

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Medizentrum Essen Borbeck

    Essen, 45355

  • AmBeNet GmbH

    Leipzig, 04107

  • Familienmedizinisches Zentrum Radowsky

    Leipzig, 04179

  • RED-Institut GmbH

    Oldenburg, 23758

Other trials in Germany

Poland8 sites

  • Uniwersytecki Szpital Kliniczny w Białymstoku

    Bialystok, 15-276

  • Centrum Medyczne "Hipokrates" S.C. Elżbieta I Grzegorz Grześk

    Bydgoszcz, 85-092

  • NZOZ Centrum Medyczne KERmed

    Bydgoszcz, 85-231

  • IRMED

    Piotrkow Trybunalski, 97-300

  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu

    Przemyśl, 37-700

  • Private Practice - Dr. Robert Witek

    Tarnów, 33-100

  • Balsam Medica

    Warsaw, 01-249

  • NZOZ Regionalna Poradnia Diabetologiczna

    Wroclaw, 50-127

Other trials in Poland

Spain7 sites

  • CHUAC-Complejo Hospitalario Universitario A Coruña

    A Coruña, 15001

  • Hospital San Rafael - La Coruña

    A Coruña, 15006

  • EAP Sardenya

    Barcelona, 08025

  • EAP Osona Sud - Alt Congost S.L.P

    Centelles, 08540

  • Complejo Asistencial Universitario de León - Hospital de León

    León, 24071

  • Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

    Seville, 41003

  • Hospital Quiron Infanta Luisa

    Seville, 41010

Other trials in Spain

Greece6 sites

  • Athens Medical Center - Psychikon branch

    Athens, 115 25

  • General Hospital of Athens "G. Gennimatas"

    Athens, 11527

  • University Hospital of Ioannina

    Ioannina, 45500

  • G. Gennimatas General Hospital of Thessaloniki

    Thessaloniki, 546 35

  • AHEPA University General Hospital of Thessaloniki

    Thessaloniki, 546 36

  • Papageorgiou General Hospital of Thessaloniki

    Thessaloniki, 56403

Other trials in Greece

Japan5 sites

  • Tokyo-Eki Center-building Clinic

    Chūōku, 103-0027

  • Fukuwa Clinic

    Chūōku, 104-0031

  • Takai Internal Medicine Clinic

    Kamakura-shi, 247-0056

  • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism

    Matsuyama, 7900034

  • Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic

    Yamato-shi, 242-0004

Other trials in Japan

India4 sites

  • Life Care Hospital and Research Centre

    Bangalore, 560092

  • All India Institute of Medical Sciences

    Bhubaneswar, 751019

  • G.B. Pant Institute of Postgraduate Medical Education & Research

    New Delhi, 110002

  • Ashirwad Hospital and Research Centre

    Ulhasnagar, 421004

Other trials in India

Puerto Rico2 sites

  • Dorado Medical Complex

    Dorado, 00646

  • Puerto Rico Medical Research

    Ponce, 00717

Other trials in Puerto Rico

About this study

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)

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.

Conditions
Hypertension
Being tested
Orforglipron, Placebo
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OrforglipronDrug

    Also called LY3502970

    Administered orally.

  • PlaceboDrug

    Administered orally.

Study groups in NCT06948422
Study groupRoleWhat they receive
Orforglipron (GZL1)ExperimentalParticipants will receive orforglipron orally or placebo.
Receives: Drug: Orforglipron; Drug: Placebo
Orforglipron (GZL2)ExperimentalParticipants will receive orforglipron orally or placebo.
Receives: Drug: Orforglipron; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Allocated to Each ISA

    Measured: Week -8 to Week 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2025
  2. Study start30 Apr 2025
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
974 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06948422
Sponsor's protocol ID
27223
Other IDs
J2A-MC-GZPL, J2A-MC-GZL1, J2A-MC-GZL2
Status last verified
May 2026
First submitted
21 Apr 2025
Last updated
29 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Laffin L, Schlaich MP, Hall ME, Xie CC, Rao G, Rettiganti M, Dennehy EB, Linetzky B. Study design, rationale, and baseline characteristics of ATTAIN-HYPERTENSION, a phase 3 trial of the oral GLP-1 receptor agonist orforglipron for hypertension. Am J Prev Cardiol. 2026 Aug 6;30:101783. doi: 10.1016/j.ajpc.2026.101783. eCollection 2026 Dec.

    PubMed 42830762

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Orforglipron in people with Hypertension, run by Eli Lilly and Company at 100 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 100 sites in United States, China, Argentina, Czechia, Germany and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Allocated to Each ISA (time frame: Week -8 to Week 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06948422, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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