A Study of Orforglipron (LY3502970) Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin

Last updated: May 29, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Not Recruiting

Phase

3

Condition

Diabetes Mellitus, Type 2

Diabetes Prevention

Diabetes And Hypertension

Treatment

Dapagliflozin

Orforglipron

Clinical Study ID

NCT06192108
18566
J2A-MC-GZGV
U1111-1296-1507
2023-507206-13-00
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to assess the safety and efficacy of orforglipron compared with dapagliflozin in improving blood sugar control in participants with type 2 diabetes (T2D) with inadequate glycemic control using metformin. The study will last approximately 46 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a clinical diagnosis of T2D based on the World Health Organizationclassification or other locally applicable diagnostic standards.

  • Have HbA1c ≥7.0% (53 mmol/mol) to ≤10.5% (91 mmol/mol) at screening.

  • Have been on stable diabetes treatment with metformin ≥1500 milligram per day (mg/day) during the 90 days prior to screening and maintained through randomization.

  • Are of stable body weight (±5%) for at least 90 days prior to screening and agree tonot initiate an intensive diet or exercise program during the study with the intentof reducing body weight, other than the lifestyle and/or dietary measures fordiabetes treatment.

  • Have a body mass index (BMI) ≥23.0 kilogram/square meter (kg/m²) at screening.

Exclusion

Exclusion Criteria:

  • Have Type 1 Diabetes (T1D)

  • Are currently receiving or planning to receive treatment for diabetic retinopathyand/or macular edema

  • Have an estimated glomerular filtration rate (eGFR) <45 milliliter per minute (mL/min)/1.73 square meter (m2)

  • Have acute or chronic hepatitis

  • Have had chronic or acute pancreatitis any time.

  • Have been treated with any antihyperglycemic medication (other than metformin)within the 90 days prior to screening.

Study Design

Total Participants: 888
Treatment Group(s): 2
Primary Treatment: Dapagliflozin
Phase: 3
Study Start date:
January 10, 2024
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • The Second People's Hospital of Hefei

    Hefei, Anhui 230011
    China

    Site Not Available

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Site Not Available

  • The Fourth Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanyang Medical College

    Nanyang, Henan 473007
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450014
    China

    Site Not Available

  • Nanjing First Hospital

    Nanjing, Jiangsu 210006
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu 210011
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu 212000
    China

    Site Not Available

  • Jinan Central Hospital

    Jinan, Shandong 250013
    China

    Site Not Available

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan 650032
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

  • CRS Clinical Research Services Mannheim

    Mannheim, Baden-Württemberg 68167
    Germany

    Site Not Available

  • Diabetologische Schwerpunktpraxis Dr. Staudenmeyer & Dr. Schiwietz

    Lingen, Niedersachsen 49808
    Germany

    Site Not Available

  • Diabetes- und Stoffwechselpraxis Bochum

    Bochum, Nordrhein-Westfalen 44869
    Germany

    Site Not Available

  • InnoDiab Forschung Gmbh

    Essen, Nordrhein-Westfalen 45136
    Germany

    Site Not Available

  • Medizentrum Essen Borbeck

    Essen, Nordrhein-Westfalen 45355
    Germany

    Site Not Available

  • Zentrum fur klinische Forschung - Köln

    Köln, Nordrhein-Westfalen 51069
    Germany

    Site Not Available

  • Institut für Diabetesforschung GmbH Münster

    Münster, Nordrhein-Westfalen 48145
    Germany

    Site Not Available

  • Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz

    Ludwigshafen am Rhein, Rheinland-Pfalz 67059
    Germany

    Site Not Available

  • Diabetologische Schwerpunktpraxis und Praxis für Allgemeinmedizin Dr. Veronika Wenzl-Bauer null Josef Wenzl

    Rehlingen, Saarland 66780
    Germany

    Active - Recruiting

  • Diabetologische Schwerpunktpraxis und Praxis für Allgemeinmedizin Dr. Veronika Wenzl-Bauer u. Dr. Josef We -T

    Rehlingen, Saarland 66780
    Germany

    Active - Recruiting

  • Praxis Dr. Veronika Wenzl-Bauer

    Rehlingen, Saarland 66780
    Germany

    Site Not Available

  • Zentrum für klinische Studien

    Saint Ingbert, Saarland 66386
    Germany

    Site Not Available

  • Zentrum für klinische Studien

    St.Ingbert, Saarland 66386
    Germany

    Site Not Available

  • RED-Institut GmbH

    Oldenburg, Schleswig-Holstein 23758
    Germany

    Site Not Available

  • Gemeinschaftspraxis für Diabetologie

    Eisenach, Thüringen 99817
    Germany

    Site Not Available

  • Diabetes Zentrum Wilhelmsburg

    Hamburg, 21109
    Germany

    Site Not Available

  • Cryptex Investigación Clínica S.A. de C.V.

    Cuauhtémoc, Distrito Federal 06100
    Mexico

    Site Not Available

  • Cryptex Investigación Clínica S.A. de C.V.

    Cuauhtémoc, Ciudad De México, Distrito Federal 06100
    Mexico

    Site Not Available

  • ProcliniQ Investigación Clínica SA de CV

    Mexico City, Distrito Federal 14050
    Mexico

    Site Not Available

  • Grupo Ollin Care

    Pachuca, Hidalgo 42000
    Mexico

    Site Not Available

  • Instituto Jalisciense de Investigacion en Diabetes y Obesidad

    Guadalajara, Jalisco 44600
    Mexico

    Site Not Available

  • Instituto de Diabetes, Obesidad y Nutricion

    Cuernavaca, Morelos 62250
    Mexico

    Site Not Available

  • Invecordis S.C.

    Hacienda De Las Palmas, México 52763
    Mexico

    Site Not Available

  • Cardiolink Clin Trials

    Monterrey, Nuevo León 64060
    Mexico

    Site Not Available

  • Clínica García Flores SC

    Monterrey, Nuevo León 64610
    Mexico

    Site Not Available

  • Servicios Integrales Nova de Monterrey S.A. de C.V.

    San Nicolas de los Garza, Nuevo León 66450
    Mexico

    Site Not Available

  • Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.

    Culiacan, Sinaloa 80230
    Mexico

    Site Not Available

  • Consultorio de Medicina Especilizada del Sector Privado

    Xalapa, Veracruz 91193
    Mexico

    Site Not Available

  • Hospital Angeles Xalapa

    Xalapa, Veracruz 91193
    Mexico

    Site Not Available

  • Fundación Cardiovascular de Aguascalientes A.C.

    Aguascalientes, 20230
    Mexico

    Site Not Available

  • Estudios Clínicos Internacionales (ECI) - Cuautitlán Izcalli

    Cuautitlán Izcalli, 54700
    Mexico

    Site Not Available

  • Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia

    Durango, 34000
    Mexico

    Site Not Available

  • PanAmerican Clinical Research - Querétaro - Avenida Antea

    Querétaro, 76100
    Mexico

    Site Not Available

  • Centrum Badań Klinicznych Piotr Napora lekarze sp.p.

    Wroclaw, Dolnośląskie 50-162
    Poland

    Site Not Available

  • NZOZ Centrum Medyczne KERmed

    Bydgoszcz, Kujawsko-pomorskie 85-231
    Poland

    Site Not Available

  • CenterMed Lublin NZOZ

    Lublin, Lubelskie 20-044
    Poland

    Site Not Available

  • Clinical Best Solutions

    Lublin, Lubelskie 20-011
    Poland

    Site Not Available

  • Ekamed

    Lublin, Lubelskie 20-718
    Poland

    Site Not Available

  • NZOZ Medica

    Lublin, Lubelskie 20-538
    Poland

    Active - Recruiting

  • NZOZ Przychodnia Specjalistyczna Medica

    Lublin, Lubelskie 20-538
    Poland

    Active - Recruiting

  • Centrum Medyczne "Diabetika"

    Radom, Mazowieckie 26-600
    Poland

    Site Not Available

  • Niepubliczny Zakład Opieki Zdrowotnej "Przychodnia z Sercem"

    Grojec, Małopolskie 32-615
    Poland

    Site Not Available

  • Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET

    Krakow, Małopolskie 31-261
    Poland

    Site Not Available

  • NZOZ Diab-Endo-Met

    Krakow, Małopolskie 31-261
    Poland

    Active - Recruiting

  • Osteo Medic sc A. Racewicz, J. Supronik

    Bialystok, Podlaskie 15-351
    Poland

    Active - Recruiting

  • Specderm Poznanska

    Bialystok, Podlaskie 15-375
    Poland

    Site Not Available

  • Zdrowie Osteo-Medic

    Bialystok, Podlaskie 15-351
    Poland

    Site Not Available

  • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

    Lodz, Łódzkie 90-338
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny nr 1 SUM

    Zabrze, Śląskie 41-800
    Poland

    Site Not Available

  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung Niao Sung Dist, Kaohsiung 83301
    Taiwan

    Site Not Available

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, 807
    Taiwan

    Site Not Available

  • Kaohsiung Medical University Hospital

    Kaohsiung, 807
    Taiwan

    Active - Recruiting

  • Kaohsiung Veterans General Hospital

    Kaohsiung, 81362
    Taiwan

    Site Not Available

  • Fu Jen Catholic University Hospital

    New Taipei, 24352
    Taiwan

    Site Not Available

  • Taichung Veterans General Hospital

    Taichung, 407
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Site Not Available

  • Alliance Research Institute - Canoga Park

    Canoga Park, California 91304
    United States

    Site Not Available

  • Ark Clinical Research

    Long Beach, California 90815
    United States

    Site Not Available

  • Collaborative Neuroscience Research, LLC

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Wolverine Clinical Trials

    Santa Ana, California 92705
    United States

    Site Not Available

  • Wolverine Clinical Trials

    Tustin, California 92780
    United States

    Site Not Available

  • CMR of Greater New Haven

    Hamden, Connecticut 06517
    United States

    Active - Recruiting

  • CMR of Greater New Haven, LLC

    Hamden, Connecticut 06517
    United States

    Site Not Available

  • Institute of Endocrinology Diabetes, Health & Hormone

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Elite Clinical Trials

    Rexburg, Idaho 83440
    United States

    Site Not Available

  • Accellacare - DuPage

    Lombard, Illinois 60148
    United States

    Site Not Available

  • Tandem Clinical Research

    Marrero, Louisiana 70072
    United States

    Site Not Available

  • St. Vincent Healthcare

    Billings, Montana 59101
    United States

    Site Not Available

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Accellacare - Winston-Salem

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Intend Research, LLC

    Norman, Oklahoma 73069
    United States

    Active - Recruiting

  • Essential Medical Research

    Tulsa, Oklahoma 74137
    United States

    Site Not Available

  • Accellacare - Mt Pleasant

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Accellacare, US Inc., d/b/a Accellacare of Knoxville

    Jefferson City, Tennessee 37760
    United States

    Site Not Available

  • Dallas Diabetes Research Center

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • Velocity Clinical Research, Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • Juno Research

    Houston, Texas 77040
    United States

    Site Not Available

  • Consano Clinical Research, LLC

    Shavano Park, Texas 78231
    United States

    Site Not Available

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