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A Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL1

Phase 3
Not yet recruiting
Conditions
Hypertension
Overweight or Obesity
Interventions
Drug: Placebo
Registration Number
NCT06948435
Lead Sponsor
Eli Lilly and Company
Brief Summary

GZL1 is an independent study conducted under the GZPL master protocol. GZL1 will evaluate the efficacy and safety of orforglipron for treatment of hypertension in participants with obesity or overweight.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
487
Inclusion Criteria
  • refer to the GZPL master protocol for screening eligibility.
Exclusion Criteria
  • refer to the GZPL master protocol for screening eligibility.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
OrforglipronOrforglipronParticipants will receive orforglipron orally.
PlaceboPlaceboAdministered placebo.
Primary Outcome Measures
NameTimeMethod
Change from Baseline in office Systolic Blood Pressure (SBP)Baseline to Week 36
Secondary Outcome Measures
NameTimeMethod
Change from Baseline in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) SBPBaseline to Week 36
Percent Change from Baseline in Body WeightBaseline to Week 36
Percent Change from Baseline in TriglyceridesBaseline to Week 36
Percent Change from Baseline in non-HDL CholesterolBaseline to Week 36
Percent Change from Baseline in hsCRP Concentration (mg/L)Baseline to Week 48
Change in office SBP in Randomized Withdrawal PopulationWeek 48 to Week 60
Pharmacokinetics (PK): Steady-State Area Under the Concentration Curve (AUC) of OrforglipronBaseline to Week 36

Trial Locations

Locations (100)

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

Saratoga Clinical Research

🇺🇸

Saratoga Springs, 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

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 Shi, 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

Top Moravia Health

🇨🇿

Brno, Brno-město, Czechia

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

Diahelp s.r.o

🇨🇿

Pardubice V, Pardubice, Czechia

Angiocentrum Komorany

🇨🇿

Prague, Praha 12, Czechia

MUDr. Sarka Drinkova

🇨🇿

Ledec nad Sazavou, Vysočina, 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

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