Clinical trial NCT06948422: A Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2025-04-29
Enrollment: 974
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Allocated to Each ISA
timeFrame: Week -8 to Week 0
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Elite Clinical Studies, LLC
state: Arizona
city: Covina
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials
state: Florida
city: Brandon
country: United States
facility: Care Access - Brandon
state: Florida
city: Jacksonville
country: United States
facility: Northeast Research Institute - Downtown Office
state: Florida
city: Port Charlotte
country: United States
facility: Peace River Cardiovascular Center
state: Florida
city: Sun City Center
country: United States
facility: Care Access - Sun City Center - Cypress Village Boulevard
state: Florida
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Baltimore
country: United States
facility: Sinai Hospital Of Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Ascension Saint Agnes Heart Care
state: Maryland
city: New Bedford
country: United States
facility: Lucida Clinical Trials
state: Massachusetts
city: Troy
country: United States
facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
state: Michigan
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Las Vegas
country: United States
facility: Excel Clinical Research, LLC
state: Nevada
city: Las Vegas
country: United States
facility: Palm Research Center Sunset
state: Nevada
city: Rochester
country: United States
facility: Rochester Clinical Research, LLC
state: New York
city: Columbus
country: United States
facility: Remington-Davis, Inc
state: Ohio
city: Dayton
country: United States
facility: PriMED Clinical Research
state: Ohio
city: Tigard
country: United States
facility: Advanced Research Institute - Tigard
state: Oregon
city: Mauldin
country: United States
facility: Care Access - Mauldin
state: South Carolina
city: McKinney
country: United States
facility: Texas Institute of Cardiology, PA
state: Texas
city: North Richland Hills
country: United States
facility: North Hills Family Medicine/North Hills Medical Research
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Manassas
country: United States
facility: Carient Heart & Vascular - Manassas
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc.
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research, Inc
state: Virginia
city: Redmond
country: United States
facility: Eastside Research Associates
state: Washington
city: San Isidro
country: Argentina
facility: Santa Maria de la Salud Centro Medico
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: CIPREC
state: Ciudad Autónoma De Buenos Aires
city: Granadero Baigorria
country: Argentina
facility: Centro de Investigaciones Clínicas Baigorria
state: Santa Fe
city: Rosario
country: Argentina
facility: INECO Neurociencias Oroño
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Instituto Médico Especializado (IME)
city: Buenos Aires
country: Argentina
facility: CIPREC
city: Buenos Aires
country: Argentina
facility: CEMEDIC
city: Córdoba
country: Argentina
facility: Instituto de Investigaciones Clínicas Córdoba
city: Beijing
country: China
facility: Beijing Pinggu District Hospital
state: Beijing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University - Yuzhong Campus
state: Chongqing
city: Luoyang Shi
country: China
facility: The First Affiliated Hospital of Henan University of Science &Technology
state: Henan
city: Changde
country: China
facility: Changde First People's Hospital
state: Hunan
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Changchun
country: China
facility: China-Japan Union Hospital
state: Jilin
city: Siping
country: China
facility: Siping Central People's Hospital
state: Jilin
city: Xian
country: China
facility: Shaanxi provincial people's hospital
state: Shaanxi
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Lishui City
country: China
facility: Lishui Central Hospital
state: Zhejiang
city: Brno
country: Czechia
facility: Top Moravia Health
state: Brno-město
city: Brno
country: Czechia
facility: Ordinace Rihackovi, s.r.o.
state: Brno-město
city: Hodonin
country: Czechia
facility: CTC Hodonin s.r.o.
state: Hodonín
city: Ostrava
country: Czechia
facility: CCR Ostrava s.r.o
state: Moravskoslezský Kraj
city: Pardubice V
country: Czechia
facility: Diahelp s.r.o
state: Pardubice
city: Prague
country: Czechia
facility: Angiocentrum Komorany
state: Praha 12
city: Ledec nad Sazavou
country: Czechia
facility: MUDr. Sarka Drinkova
state: Vysočina
city: Praha 4
country: Czechia
facility: Clinoxus
city: Praha 5
country: Czechia
facility: Praglandia s.r.o
city: Bad Homburg
country: Germany
facility: Kardiologische Praxis Dr. med. univ. Wolfgang Jungmair
state: Hessen
city: Essen
country: Germany
facility: Medizentrum Essen Borbeck
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Zentrum fur klinische Forschung - Köln
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Hausärztlich-Kardiologisches MVZ am Felsenkeller GmbH/Zentrum für klinische Studien
state: Sachsen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden
state: Sachsen
city: Leipzig
country: Germany
facility: AmBeNet GmbH
state: Sachsen
city: Leipzig
country: Germany
facility: Familienmedizinisches Zentrum Radowsky
state: Sachsen
city: Oldenburg
country: Germany
facility: RED-Institut GmbH
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: emovis GmbH
city: Athens
country: Greece
facility: Athens Medical Center - Psychikon branch
state: Attikí (Region)
city: Athens
country: Greece
facility: General Hospital of Athens "G. Gennimatas"
state: Attikí
city: Ioannina
country: Greece
facility: University Hospital of Ioannina
state: Ioánnina
city: Thessaloniki
country: Greece
facility: G. Gennimatas General Hospital of Thessaloniki
state: Thessaloníki
city: Thessaloniki
country: Greece
facility: AHEPA University General Hospital of Thessaloniki
state: Thessaloníki
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital of Thessaloniki
state: Thessaloníki
city: New Delhi
country: India
facility: G.B. Pant Institute of Postgraduate Medical Education & Research
state: Delhi
city: Bangalore
country: India
facility: Life Care Hospital and Research Centre
state: Karnataka
city: Ulhasnagar
country: India
facility: Ashirwad Hospital and Research Centre
state: Maharashtra
city: Bhubaneswar
country: India
facility: All India Institute of Medical Sciences
state: Odisha
city: Matsuyama
country: Japan
facility: Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
state: Ehime
city: Kamakura-shi
country: Japan
facility: Takai Internal Medicine Clinic
state: Kanagawa
city: Yamato-shi
country: Japan
facility: Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
state: Kanagawa
city: Chuo-ku
country: Japan
facility: Tokyo-Eki Center-building Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic
state: Tokyo
city: Wroclaw
country: Poland
facility: NZOZ Regionalna Poradnia Diabetologiczna
state: Dolnośląskie
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne "Hipokrates" S.C. Elżbieta I Grzegorz Grześk
state: Kujawsko-pomorskie
city: Bydgoszcz
country: Poland
facility: NZOZ Centrum Medyczne KERmed
state: Kujawsko-pomorskie
city: Warsaw
country: Poland
facility: Balsam Medica
state: Mazowieckie
city: Tarnów
country: Poland
facility: Private Practice - Dr. Robert Witek
state: Małopolskie
city: Przemysl
country: Poland
facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
state: Podkarpackie
city: Białystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Białymstoku
state: Podlaskie
city: Piotrkow Trybunalski
country: Poland
facility: IRMED
state: Łódzkie
city: Dorado
country: Puerto Rico
facility: Dorado Medical Complex
city: Ponce
country: Puerto Rico
facility: Puerto Rico Medical Research
city: A Coruña
country: Spain
facility: CHUAC-Complejo Hospitalario Universitario A Coruña
state: A Coruña [La Coruña]
city: La Coruña
country: Spain
facility: Hospital San Rafael - La Coruña
state: A Coruña [La Coruña]
city: Sevilla
country: Spain
facility: Hospital Quiron Infanta Luisa
state: Andalucía
city: Barcelona
country: Spain
facility: EAP Sardenya
state: Barcelona [Barcelona]
city: Centelles
country: Spain
facility: EAP Osona Sud - Alt Congost S.L.P
state: Barcelona [Barcelona]
city: León
country: Spain
facility: Complejo Asistencial Universitario de León - Hospital de León
state: Castilla Y León
city: Sevilla
country: Spain
facility: Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: