A Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening)
- Registration Number
- NCT06948422
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 974
- 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.
-
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Orforglipron (GZL1) Orforglipron Participants will receive orforglipron orally or placebo. Orforglipron (GZL1) Placebo Participants will receive orforglipron orally or placebo. Orforglipron (GZL2) Orforglipron Participants will receive orforglipron orally or placebo. Orforglipron (GZL2) Placebo Participants will receive orforglipron orally or placebo.
- Primary Outcome Measures
Name Time Method Number of Participants Allocated to Each ISA Week -8 to Week 0
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (99)
Elite Clinical Studies, LLC
🇺🇸Phoenix, Arizona, United States
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
Excel Medical Clinical Trials
🇺🇸Boca Raton, Florida, United States
Care Access - Brandon
🇺🇸Brandon, Florida, United States
Northeast Research Institute - Downtown Office
🇺🇸Jacksonville, Florida, United States
Peace River Cardiovascular Center
🇺🇸Port Charlotte, Florida, United States
Care Access - Sun City Center - Cypress Village Boulevard
🇺🇸Sun City Center, Florida, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
Sinai Hospital Of Baltimore
🇺🇸Baltimore, Maryland, United States
Ascension Saint Agnes Heart Care
🇺🇸Baltimore, Maryland, United States
Lucida Clinical Trials
🇺🇸New Bedford, Massachusetts, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
🇺🇸Troy, Michigan, United States
StudyMetrix Research
🇺🇸Saint Peters, Missouri, United States
Excel Clinical Research, LLC
🇺🇸Las Vegas, Nevada, United States
Palm Research Center Sunset
🇺🇸Las Vegas, Nevada, United States
Rochester Clinical Research, LLC
🇺🇸Rochester, New York, United States
Remington-Davis, Inc
🇺🇸Columbus, Ohio, United States
PriMED Clinical Research
🇺🇸Dayton, Ohio, United States
Advanced Research Institute - Tigard
🇺🇸Tigard, Oregon, United States
Care Access - Mauldin
🇺🇸Mauldin, South Carolina, United States
Texas Institute of Cardiology, PA
🇺🇸McKinney, Texas, United States
North Hills Family Medicine/North Hills Medical Research
🇺🇸North Richland Hills, Texas, United States
Advanced Research Institute
🇺🇸Ogden, Utah, United States
Carient Heart & Vascular - Manassas
🇺🇸Manassas, Virginia, United States
Top Moravia Health
🇨🇿Brno, Brno-město, Czechia
Health Research of Hampton Roads, Inc.
🇺🇸Newport News, Virginia, United States
National Clinical Research, Inc
🇺🇸Richmond, Virginia, United States
Eastside Research Associates
🇺🇸Redmond, Washington, United States
Central Washington Health Services Association d/b/a Confluence Health
🇺🇸Wenatchee, Washington, United States
Santa Maria de la Salud Centro Medico
🇦🇷San Isidro, Buenos Aires, Argentina
CIPREC
🇦🇷Buenos Aires, Argentina
Centro de Investigaciones Clínicas Baigorria
🇦🇷Granadero Baigorria, Santa Fe, Argentina
INECO Neurociencias Oroño
🇦🇷Rosario, Santa Fe, Argentina
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
🇦🇷Rosario, Santa Fe, Argentina
Instituto Médico Especializado (IME)
🇦🇷Buenos Aires, Argentina
CEMEDIC
🇦🇷Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Córdoba
🇦🇷Córdoba, Argentina
Beijing Pinggu District Hospital
🇨🇳Beijing, Beijing, China
The Second Affiliated Hospital of Chongqing Medical University - Yuzhong Campus
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Henan University of Science &Technology
🇨🇳Luoyang, Henan, China
Changde First People's Hospital
🇨🇳Changde, Hunan, China
Wuxi People's Hospital
🇨🇳Wuxi, Jiangsu, China
China-Japan Union Hospital
🇨🇳Changchun, Jilin, China
Siping Central People's Hospital
🇨🇳Siping, Jilin, China
Shaanxi provincial people's hospital
🇨🇳Xian, Shaanxi, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
Lishui Central Hospital
🇨🇳Lishui, Zhejiang, China
Ordinace Rihackovi, s.r.o.
🇨🇿Brno, Brno-město, Czechia
CTC Hodonin s.r.o.
🇨🇿Hodonin, Hodonín, Czechia
CCR Ostrava s.r.o
🇨🇿Ostrava, Moravskoslezský Kraj, Czechia
Angiocentrum Komorany
🇨🇿Prague, Praha 12, Czechia
MUDr. Sarka Drinkova
🇨🇿Ledec nad Sazavou, Vysočina, Czechia
Diahelp s.r.o
🇨🇿Pardubice, Czechia
Clinoxus
🇨🇿Praha 4, Czechia
Praglandia s.r.o
🇨🇿Praha 5, Czechia
Kardiologische Praxis Dr. med. univ. Wolfgang Jungmair
🇩🇪Bad Homburg, Hessen, Germany
Medizentrum Essen Borbeck
🇩🇪Essen, Nordrhein-Westfalen, Germany
Zentrum fur klinische Forschung - Köln
🇩🇪Köln, Nordrhein-Westfalen, Germany
Hausärztlich-Kardiologisches MVZ am Felsenkeller GmbH/Zentrum für klinische Studien
🇩🇪Dresden, Sachsen, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
🇩🇪Dresden, Sachsen, Germany
AmBeNet GmbH
🇩🇪Leipzig, Sachsen, Germany
Familienmedizinisches Zentrum Radowsky
🇩🇪Leipzig, Sachsen, Germany
RED-Institut GmbH
🇩🇪Oldenburg, Schleswig-Holstein, Germany
emovis GmbH
🇩🇪Berlin, Germany
Athens Medical Center - Psychikon branch
🇬🇷Athens, Attikí (Region), Greece
General Hospital of Athens "G. Gennimatas"
🇬🇷Athens, Attikí, Greece
University Hospital of Ioannina
🇬🇷Ioannina, Ioánnina, Greece
G. Gennimatas General Hospital of Thessaloniki
🇬🇷Thessaloniki, Thessaloníki, Greece
AHEPA University General Hospital of Thessaloniki
🇬🇷Thessaloniki, Thessaloníki, Greece
Papageorgiou General Hospital of Thessaloniki
🇬🇷Thessaloniki, Thessaloníki, Greece
G.B. Pant Institute of Postgraduate Medical Education & Research
🇮🇳New Delhi, Delhi, India
Life Care Hospital and Research Centre
🇮🇳Bangalore, Karnataka, India
Ashirwad Hospital and Research Centre
🇮🇳Ulhasnagar, Maharashtra, India
All India Institute of Medical Sciences
🇮🇳Bhubaneswar, Odisha, India
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
🇯🇵Matsuyama, Ehime, Japan
Takai Internal Medicine Clinic
🇯🇵Kamakura-shi, Kanagawa, Japan
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
🇯🇵Yamato-shi, Kanagawa, Japan
Tokyo-Eki Center-building Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Fukuwa Clinic
🇯🇵Chuo-ku, Tokyo, Japan
NZOZ Regionalna Poradnia Diabetologiczna
🇵🇱Wroclaw, Dolnośląskie, Poland
Centrum Medyczne "Hipokrates" S.C. Elżbieta I Grzegorz Grześk
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
NZOZ Centrum Medyczne KERmed
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Balsam Medica
🇵🇱Warsaw, Mazowieckie, Poland
Private Practice - Dr. Robert Witek
🇵🇱Tarnów, Małopolskie, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu
🇵🇱Przemysl, Podkarpackie, Poland
Uniwersytecki Szpital Kliniczny w Białymstoku
🇵🇱Białystok, Podlaskie, Poland
IRMED
🇵🇱Piotrkow Trybunalski, Łódzkie, Poland
Dorado Medical Complex
🇵🇷Dorado, Puerto Rico
Puerto Rico Medical Research
🇵🇷Ponce, Puerto Rico
CHUAC-Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruña, A Coruña [La Coruña], Spain
Hospital San Rafael - La Coruña
🇪🇸La Coruña, A Coruña [La Coruña], Spain
Hospital Quiron Infanta Luisa
🇪🇸Sevilla, Andalucía, Spain
EAP Sardenya
🇪🇸Barcelona, Barcelona [Barcelona], Spain
EAP Osona Sud - Alt Congost S.L.P
🇪🇸Centelles, Barcelona [Barcelona], Spain
Complejo Asistencial Universitario de León - Hospital de León
🇪🇸León, Castilla Y León, Spain
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
🇪🇸Sevilla, Spain