NCT06952530

Brief Summary

GZL2 is an independent study conducted under the GZPL master protocol. GZL2 study will evaluate the efficacy and safety of orforglipron for treatment of hypertension in participants with obesity or overweight.

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
487

participants targeted

Target at P50-P75 for phase_3 hypertension

Timeline
16mo left

Started Apr 2025

Typical duration for phase_3 hypertension

Geographic Reach
11 countries

99 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Apr 2025Sep 2027

First Submitted

Initial submission to the registry

April 21, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

April 30, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

2.3 years

First QC Date

April 21, 2025

Last Update Submit

April 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in office Systolic Blood Pressure (SBP)

    Baseline to Week 36

Secondary Outcomes (7)

  • Change from Baseline in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) SBP

    Baseline to Week 36

  • Percent Change from Baseline in Body Weight

    Baseline to Week 36

  • Percent Change from Baseline in Lipids Triglycerides

    Baseline to Week 36

  • Percent Change from Baseline in Lipids non-HDL Cholesterol

    Baseline to Week 36

  • Percent Change from Baseline in hsCRP Concentration (mg/L)

    Baseline to Week 36

  • +2 more secondary outcomes

Study Arms (2)

Orforglipron

EXPERIMENTAL

Participants will receive orforglipron orally.

Drug: Orforglipron

Placebo

PLACEBO COMPARATOR

Participants receive placebo.

Drug: Placebo

Interventions

Administered orally

Also known as: LY3502970
Orforglipron

placebo administered

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • refer to the GZPL master protocol study for screening eligibility.

You may not qualify if:

  • refer to the GZPL master protocol study for screening eligibility.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (99)

Elite Clinical Studies, LLC

Phoenix, Arizona, 85018, United States

ACTIVE NOT RECRUITING

Valley Clinical Trials, Inc.

Covina, California, 91723, United States

ACTIVE NOT RECRUITING

Valley Clinical Trials, Inc.

Northridge, California, 91325, United States

ACTIVE NOT RECRUITING

Chase Medical Research, LLC

Waterbury, Connecticut, 06708, United States

ACTIVE NOT RECRUITING

Excel Medical Clinical Trials

Boca Raton, Florida, 33434, United States

ACTIVE NOT RECRUITING

Care Access - Brandon

Brandon, Florida, 33510, United States

ACTIVE NOT RECRUITING

Northeast Research Institute - Downtown Office

Jacksonville, Florida, 32204, United States

ACTIVE NOT RECRUITING

Peace River Cardiovascular Center

Port Charlotte, Florida, 33952, United States

NOT YET RECRUITING

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

ACTIVE NOT RECRUITING

Sinai Hospital Of Baltimore

Baltimore, Maryland, 21209, United States

ACTIVE NOT RECRUITING

Ascension Saint Agnes Heart Care

Baltimore, Maryland, 21229, United States

ACTIVE NOT RECRUITING

Lucida Clinical Trials

New Bedford, Massachusetts, 02740, United States

ACTIVE NOT RECRUITING

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan, 48098, United States

ACTIVE NOT RECRUITING

StudyMetrix Research

City of Saint Peters, Missouri, 63303, United States

ACTIVE NOT RECRUITING

Excel Clinical Research, LLC

Las Vegas, Nevada, 89109, United States

ACTIVE NOT RECRUITING

Palm Research Center Sunset

Las Vegas, Nevada, 89148, United States

ACTIVE NOT RECRUITING

Rochester Clinical Research, LLC

Rochester, New York, 14609, United States

ACTIVE NOT RECRUITING

Remington-Davis, Inc

Columbus, Ohio, 43215, United States

ACTIVE NOT RECRUITING

Advanced Research Institute - Tigard

Tigard, Oregon, 97223, United States

COMPLETED

Care Access - Mauldin

Mauldin, South Carolina, 29662, United States

ACTIVE NOT RECRUITING

Dallas Heart and Vascular Consultants, PA

Duncanville, Texas, 75137, United States

ACTIVE NOT RECRUITING

Texas Institute of Cardiology, PA

McKinney, Texas, 75071, United States

ACTIVE NOT RECRUITING

North Hills Family Medicine/North Hills Medical Research

North Richland Hills, Texas, 76180, United States

ACTIVE NOT RECRUITING

Advanced Research Institute

Ogden, Utah, 84405, United States

ACTIVE NOT RECRUITING

Carient Heart & Vascular - Manassas

Manassas, Virginia, 20109, United States

ACTIVE NOT RECRUITING

Health Research of Hampton Roads, Inc.

Newport News, Virginia, 23606, United States

ACTIVE NOT RECRUITING

National Clinical Research, Inc

Richmond, Virginia, 23294, United States

ACTIVE NOT RECRUITING

Eastside Research Associates

Redmond, Washington, 98052, United States

ACTIVE NOT RECRUITING

Instituto Médico Especializado (IME)

Buenos Aires, 1405, Argentina

ACTIVE NOT RECRUITING

CIPREC

Buenos Aires, C1061AAS, Argentina

ACTIVE NOT RECRUITING

CIPREC

Buenos Aires, C1119ACN, Argentina

ACTIVE NOT RECRUITING

CEMEDIC

Buenos Aires, C1407GTN, Argentina

ACTIVE NOT RECRUITING

Instituto de Investigaciones Clínicas Córdoba

Córdoba, 5000, Argentina

ACTIVE NOT RECRUITING

Centro de Investigaciones Clínicas Baigorria

Granadero Baigorria, 2152, Argentina

ACTIVE NOT RECRUITING

INECO Neurociencias Oroño

Rosario, 2000, Argentina

ACTIVE NOT RECRUITING

Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica

Rosario, 2000, Argentina

ACTIVE NOT RECRUITING

Santa Maria de la Salud Centro Medico

San Isidro, 1642, Argentina

ACTIVE NOT RECRUITING

Beijing Pinggu District Hospital

Beijing, 101200, China

ACTIVE NOT RECRUITING

China-Japan Union Hospital

Changchun, 130033, China

ACTIVE NOT RECRUITING

Changde First People's Hospital

Changde, 415000, China

ACTIVE NOT RECRUITING

Sichuan Provincial People's Hospital

Chengdu, 610072, China

COMPLETED

The Second Affiliated Hospital of Chongqing Medical University - Yuzhong Campus

Chongqing, 400010, China

ACTIVE NOT RECRUITING

Jinan Central Hospital

Jinan, 250013, China

ACTIVE NOT RECRUITING

Lishui Central Hospital

Lishui, China

ACTIVE NOT RECRUITING

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang Shi, 471003, China

ACTIVE NOT RECRUITING

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, 200001, China

ACTIVE NOT RECRUITING

Siping Central People's Hospital

Siping, 136000, China

ACTIVE NOT RECRUITING

Wuxi People's Hospital

Wuxi, 214023, China

ACTIVE NOT RECRUITING

Shaanxi provincial people's hospital

Xi'an, 710068, China

ACTIVE NOT RECRUITING

Top Moravia Health

Brno, 61500, Czechia

ACTIVE NOT RECRUITING

Ordinace Rihackovi, s.r.o.

Brno, 641 00, Czechia

ACTIVE NOT RECRUITING

CTC Hodonin s.r.o.

Hodonín, 695 01, Czechia

ACTIVE NOT RECRUITING

MUDr. Sarka Drinkova

Ledeč nad Sázavou, 584 01, Czechia

ACTIVE NOT RECRUITING

CCR Ostrava s.r.o

Ostrava, 702 00, Czechia

ACTIVE NOT RECRUITING

Diahelp s.r.o

Pardubice V, 530 02, Czechia

ACTIVE NOT RECRUITING

Clinoxus

Prague, 140 00, Czechia

ACTIVE NOT RECRUITING

Angiocentrum Komorany

Prague, 143 00, Czechia

ACTIVE NOT RECRUITING

Praglandia s.r.o

Prague, 150 00, Czechia

ACTIVE NOT RECRUITING

Zentrum für klinische Studien Bad Homburg

Bad Homburg, 61348, Germany

ACTIVE NOT RECRUITING

FutureMeds GmbH

Berlin, 10629, Germany

ACTIVE NOT RECRUITING

Zentrum fur klinische Forschung - Köln

Cologne, 51069, Germany

ACTIVE NOT RECRUITING

Hausärztlich-Kardiologisches MVZ am Felsenkeller GmbH/Zentrum für klinische Studien

Dresden, 01277, Germany

ACTIVE NOT RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

ACTIVE NOT RECRUITING

Medizentrum Essen Borbeck

Essen, 45355, Germany

ACTIVE NOT RECRUITING

AmBeNet GmbH

Leipzig, 04107, Germany

ACTIVE NOT RECRUITING

Familienmedizinisches Zentrum Radowsky

Leipzig, 04179, Germany

ACTIVE NOT RECRUITING

RED-Institut GmbH

Oldenburg, 23758, Germany

ACTIVE NOT RECRUITING

Athens Medical Center - Psychikon branch

Athens, 115 25, Greece

ACTIVE NOT RECRUITING

General Hospital of Athens "G. Gennimatas"

Athens, 11527, Greece

ACTIVE NOT RECRUITING

University Hospital of Ioannina

Ioannina, 45500, Greece

ACTIVE NOT RECRUITING

G. Gennimatas General Hospital of Thessaloniki

Thessaloniki, 546 35, Greece

ACTIVE NOT RECRUITING

AHEPA University General Hospital of Thessaloniki

Thessaloniki, 546 36, Greece

ACTIVE NOT RECRUITING

Papageorgiou General Hospital of Thessaloniki

Thessaloniki, 56403, Greece

ACTIVE NOT RECRUITING

Life Care Hospital and Research Centre

Bangalore, 560092, India

RECRUITING

All India Institute of Medical Sciences

Bhubaneswar, 751019, India

RECRUITING

G.B. Pant Institute of Postgraduate Medical Education & Research

New Delhi, 110002, India

RECRUITING

Ashirwad Hospital and Research Centre

Ulhasnagar, 421004, India

RECRUITING

Tokyo-Eki Center-building Clinic

Chūōku, 103-0027, Japan

ACTIVE NOT RECRUITING

Fukuwa Clinic

Chūōku, 104-0031, Japan

ACTIVE NOT RECRUITING

Takai Internal Medicine Clinic

Kamakura-shi, 247-0056, Japan

ACTIVE NOT RECRUITING

Mikannohana Clinic, Diabetes, Endocrinology and Metabolism

Matsuyama, 7900034, Japan

ACTIVE NOT RECRUITING

Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic

Yamato-shi, 242-0004, Japan

ACTIVE NOT RECRUITING

Uniwersytecki Szpital Kliniczny w Białymstoku

Bialystok, 15-276, Poland

ACTIVE NOT RECRUITING

Centrum Medyczne "Hipokrates" S.C. Elżbieta I Grzegorz Grześk

Bydgoszcz, 85-092, Poland

ACTIVE NOT RECRUITING

NZOZ Centrum Medyczne KERmed

Bydgoszcz, 85-231, Poland

ACTIVE NOT RECRUITING

IRMED

Piotrkow Trybunalski, 97-300, Poland

ACTIVE NOT RECRUITING

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu

Przemyśl, 37-700, Poland

ACTIVE NOT RECRUITING

Private Practice - Dr. Robert Witek

Tarnów, 33-100, Poland

ACTIVE NOT RECRUITING

Balsam Medica

Warsaw, 01-249, Poland

ACTIVE NOT RECRUITING

NZOZ Regionalna Poradnia Diabetologiczna

Wroclaw, 50-127, Poland

ACTIVE NOT RECRUITING

Dorado Medical Complex

Dorado, 00646, Puerto Rico

ACTIVE NOT RECRUITING

Puerto Rico Medical Research

Ponce, 00717, Puerto Rico

ACTIVE NOT RECRUITING

CHUAC-Complejo Hospitalario Universitario A Coruña

A Coruña, 15001, Spain

ACTIVE NOT RECRUITING

Hospital San Rafael - La Coruña

A Coruña, 15006, Spain

ACTIVE NOT RECRUITING

EAP Sardenya

Barcelona, 08025, Spain

ACTIVE NOT RECRUITING

EAP Osona Sud - Alt Congost S.L.P

Centelles, 08540, Spain

ACTIVE NOT RECRUITING

Complejo Asistencial Universitario de León - Hospital de León

León, 24071, Spain

ACTIVE NOT RECRUITING

Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

Seville, 41003, Spain

ACTIVE NOT RECRUITING

Hospital Quiron Infanta Luisa

Seville, 41010, Spain

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

orforglipron

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

Physicians interested in becoming principal investigators please contact

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2025

First Posted

May 1, 2025

Study Start

April 30, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information

Locations