A Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening)
Phase 3 – large-scale trial before approval
Conditions:
Hypertension
Sponsor: Eli Lilly and Company
trial.available_in:
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Overview
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.
Who can participate
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
Interventions
Orforglipron
DRUG
Placebo
DRUG
Locations
100
Argentina (9)
Instituto Médico Especializado (IME)
Buenos Aires
ACTIVE_NOT_RECRUITING
CIPREC
Buenos Aires
ACTIVE_NOT_RECRUITING
CIPREC
Buenos Aires
ACTIVE_NOT_RECRUITING
CEMEDIC
Buenos Aires
ACTIVE_NOT_RECRUITING
Instituto de Investigaciones Clínicas Córdoba
Córdoba
ACTIVE_NOT_RECRUITING
Centro de Investigaciones Clínicas Baigorria
Granadero Baigorria
ACTIVE_NOT_RECRUITING
INECO Neurociencias Oroño
Rosario
ACTIVE_NOT_RECRUITING
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
Rosario
ACTIVE_NOT_RECRUITING
Santa Maria de la Salud Centro Medico
San Isidro
ACTIVE_NOT_RECRUITING
China (12)
Beijing Pinggu District Hospital
Beijing
ACTIVE_NOT_RECRUITING
China-Japan Union Hospital
Changchun
ACTIVE_NOT_RECRUITING
Changde First People's Hospital
Changde
ACTIVE_NOT_RECRUITING
Sichuan Provincial People's Hospital
Chengdu
ACTIVE_NOT_RECRUITING
The Second Affiliated Hospital of Chongqing Medical University - Yuzhong Campus
Chongqing
ACTIVE_NOT_RECRUITING
Jinan Central Hospital
Jinan
ACTIVE_NOT_RECRUITING
Lishui Central Hospital
Lishui
ACTIVE_NOT_RECRUITING
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi
ACTIVE_NOT_RECRUITING
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai
ACTIVE_NOT_RECRUITING
Siping Central People's Hospital
Siping
ACTIVE_NOT_RECRUITING
Wuxi People's Hospital
Wuxi
ACTIVE_NOT_RECRUITING
Shaanxi provincial people's hospital
Xi'an
ACTIVE_NOT_RECRUITING
Czech Republic (9)
Top Moravia Health
Brno
ACTIVE_NOT_RECRUITING
Ordinace Rihackovi, s.r.o.
Brno
ACTIVE_NOT_RECRUITING
CTC Hodonin s.r.o.
Hodonín
ACTIVE_NOT_RECRUITING
MUDr. Sarka Drinkova
Ledeč nad Sázavou
ACTIVE_NOT_RECRUITING
CCR Ostrava s.r.o
Ostrava
ACTIVE_NOT_RECRUITING
Diahelp s.r.o
Pardubice V
ACTIVE_NOT_RECRUITING
Clinoxus
Prague
ACTIVE_NOT_RECRUITING
Angiocentrum Komorany
Prague
ACTIVE_NOT_RECRUITING
Praglandia s.r.o
Prague
ACTIVE_NOT_RECRUITING
Germany (9)
Zentrum für klinische Studien Bad Homburg
Bad Homburg
ACTIVE_NOT_RECRUITING
FutureMeds GmbH
Berlin
ACTIVE_NOT_RECRUITING
Zentrum fur klinische Forschung - Köln
Cologne
ACTIVE_NOT_RECRUITING
Hausärztlich-Kardiologisches MVZ am Felsenkeller GmbH/Zentrum für klinische Studien
БГ