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

Last updated: August 25, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Hypertriglyceridemia

Stress

Circulation Disorders

Treatment

Placebo

Orforglipron

Clinical Study ID

NCT06948422
27223
J2A-MC-GZPL
J2A-MC-GZL2
J2A-MC-GZL1
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 daysprior to Visit 1.

  • Have a body mass index (BMI) ≥ 25 kg/m².

Exclusion

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 Design

Total Participants: 974
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
April 30, 2025
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Santa Maria de la Salud Centro Medico

    San Isidro, Buenos Aires 1642
    Argentina

    Site Not Available

  • Centro de Investigaciones Clínicas Baigorria

    Granadero Baigorria, Santa Fe 2152
    Argentina

    Site Not Available

  • INECO Neurociencias Oroño

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • CEMEDIC

    Buenos Aires, C1407GTN
    Argentina

    Site Not Available

  • CIPREC

    Buenos Aires, C1061AAS
    Argentina

    Active - Recruiting

  • Instituto Médico Especializado (IME)

    Buenos Aires, 1405
    Argentina

    Active - Recruiting

  • CEMEDIC

    Buenos Aires 3435910, C1407GTN
    Argentina

    Active - Recruiting

  • CIPREC

    Buenos Aires 3435910, C1061AAS
    Argentina

    Active - Recruiting

  • Instituto Médico Especializado (IME)

    Buenos Aires 3435910, 1405
    Argentina

    Active - Recruiting

  • Instituto de Investigaciones Clínicas Córdoba

    Córdoba, 5000
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clínicas Córdoba

    Córdoba 3860259, 5000
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Clínicas Baigorria

    Granadero Baigorria 3854895, 2152
    Argentina

    Active - Recruiting

  • INECO Neurociencias Oroño

    Rosario 3838583, 2000
    Argentina

    Active - Recruiting

  • Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica

    Rosario 3838583, 2000
    Argentina

    Active - Recruiting

  • Santa Maria de la Salud Centro Medico

    San Isidro 3428992, 1642
    Argentina

    Site Not Available

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    Beijing, Beijing 101200
    China

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

    Chongqing, Chongqing 400010
    China

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

    Luoyang, Henan 471003
    China

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    Changde, Hunan 415000
    China

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    Wuxi, Jiangsu 214023
    China

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    Changchun, Jilin 130033
    China

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    Siping, Jilin 136000
    China

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  • Shaanxi provincial people's hospital

    Xian, Shaanxi 710068
    China

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    Jinan, Shandong 250013
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    Shanghai, Shanghai 200001
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    Chengdu, Sichuan 610072
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    Lishui, Zhejiang
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    Beijing 1816670, 101200
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    Hodonin, Hodonín 695 01
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    Dresden, Sachsen 01307
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    Berlin, 10629
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    Cologne 2886242, 51069
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    Athens, Attikí 11527
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  • University Hospital of Ioannina

    Ioannina, Ioánnina 45500
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    Thessaloniki, Thessaloníki 546 35
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    Thessaloniki, Thessaloníki 56403
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  • Athens Medical Center - Psychikon branch

    Athens 264371, 115 25
    Greece

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    Athens 264371, 11527
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  • University Hospital of Ioannina

    Ioannina 261779, 45500
    Greece

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  • AHEPA University General Hospital of Thessaloniki

    Thessaloniki 734077, 546 36
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    New Delhi, Delhi 110002
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    Ulhasnagar 1253894, 421004
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    Matsuyama, Ehime 7900034
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    Chuo-ku, Tokyo 104-0031
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    Chūōku 10262791, 104-0031
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    Yamato-shi, 242-0004
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    Bydgoszcz, Kujawsko-pomorskie 85-092
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    Warsaw, Mazowieckie 01-249
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    Tarnów, Małopolskie 33-100
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    Przemysl, Podkarpackie 37-700
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    Białystok, Podlaskie 15-276
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    Piotrkow Trybunalski, Łódzkie 97-300
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    Bialystok 776069, 15-276
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    Bydgoszcz 3102014, 85-092
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    Dorado, 00646
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    Dorado 4564133, 00646
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  • Puerto Rico Medical Research

    Ponce, 00717
    Puerto Rico

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  • Puerto Rico Medical Research

    Ponce 4566880, 00717
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  • CHUAC-Complejo Hospitalario Universitario A Coruña

    A Coruña, A Coruña [La Coruña] 15001
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    La Coruña, A Coruña [La Coruña] 15006
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    Sevilla, Andalucía 41010
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    Barcelona, Barcelona [Barcelona] 08025
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    Centelles, Barcelona [Barcelona] 08540
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    León, Castilla Y León 24071
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    A Coruña 3119841, 15006
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    Seville 2510911, 41003
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    Covina, California 91723
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    Port Charlotte, Florida 33952
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    Troy, Michigan 48098
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    Columbus, Ohio 43215
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    Dayton, Ohio 45429
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    Columbus 4509177, Ohio 5165418 43215
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    Dayton 4509884, Ohio 5165418 45429
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    Tigard, Oregon 97223
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    Tigard 5756758, Oregon 5744337 97223
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    Mauldin, South Carolina 29662
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    Mauldin 4586523, South Carolina 4597040 29662
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    Duncanville, Texas 75137
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    McKinney, Texas 75071
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    North Richland Hills, Texas 76180
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    Duncanville 4687331, Texas 4736286 75137
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    McKinney 4710178, Texas 4736286 75071
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    North Richland Hills 4715292, Texas 4736286 76180
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    Ogden, Utah 84405
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    Manassas, Virginia 20109
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    Newport News, Virginia 23606
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    Richmond, Virginia 23294
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    Manassas 4771401, Virginia 6254928 20109
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    Newport News 4776024, Virginia 6254928 23606
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    Richmond 4781708, Virginia 6254928 23294
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    Redmond, Washington 98052
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    Wenatchee, Washington 98801
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    Redmond 5808079, Washington 5815135 98052
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