Clinical trial NCT06948435: A Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL1
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: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Hypertension
Overweight or Obesity
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2025-04-29
Enrollment: 487
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* refer to the GZPL master protocol for screening eligibility.

Exclusion Criteria:

* refer to the GZPL master protocol for screening eligibility.

Primary outcomes:
measure: Change from Baseline in office Systolic Blood Pressure (SBP)
timeFrame: Baseline to Week 36
Secondary outcomes:
measure: Change from Baseline in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) SBP
timeFrame: Baseline to Week 36
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline to Week 36
measure: Percent Change from Baseline in Triglycerides
timeFrame: Baseline to Week 36
measure: Percent Change from Baseline in non-HDL Cholesterol
timeFrame: Baseline to Week 36
measure: Percent Change from Baseline in hsCRP Concentration (mg/L)
timeFrame: Baseline to Week 48
measure: Change in office SBP in Randomized Withdrawal Population
timeFrame: Week 48 to Week 60
measure: Pharmacokinetics (PK): Steady-State Area Under the Concentration Curve (AUC) of Orforglipron
timeFrame: Baseline to Week 36
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: Saratoga Springs
country: United States
facility: Saratoga Clinical Research
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: Wenatchee
country: United States
facility: Central Washington Health Services Association d/b/a Confluence Health
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: