A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin

Last updated: April 16, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Not Recruiting

Phase

3

Condition

Diabetes Prevention

Diabetes Mellitus Types I And Ii

Diabetes And Hypertension

Treatment

Semaglutide

Orforglipron

Clinical Study ID

NCT06045221
18565
U1111-1290-6014
J2A-MC-GZGU
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to assess efficacy and safety of orforglipron compared with oral semaglutide in participants with Type 2 diabetes and inadequate glycemic control with metformin.The study will last around 61 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have Type 2 Diabetes

  • Have HbA1c ≥7.0% (53 mmol/mol) to ≤10.5% (91 mmol/mol), as determined by the centrallaboratory at screening.

  • Have been on stable diabetes treatment with metformin ≥1500 milligram (mg)/dayduring 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

Exclusion

Exclusion Criteria:

  • Have Type 1 Diabetes

  • Are currently receiving or planning to receive treatment for diabetic retinopathyand/or macular edema, for example, laser photocoagulation or intravitreal injectionsof anti-vascular endothelial growth factor inhibitors.

  • Have a history of ketoacidosis or hyperosmolar state or coma within the last 6months prior to screening, or between screening and randomization.

  • Have a New York Heart Association functional classification IV congestive heartfailure.

  • Have an estimated glomerular filtration rate (eGFR) <45 milliliter/minute (mL/min)/1.73 square meter (m²) or lower than the country-specific threshold fordiscontinuing metformin therapy per local label as determined by the centrallaboratory at screening.

  • Have a serum calcitonin level of ≥35 nanogram/Liter (ng/L), as determined by thecentral laboratory at screening.

  • Have a history of an active or untreated malignancy or are in remission from aclinically significant malignancy for less than 5 years.

Study Design

Total Participants: 1576
Treatment Group(s): 2
Primary Treatment: Semaglutide
Phase: 3
Study Start date:
September 22, 2023
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aires, Buenos Aires 1056
    Argentina

    Site Not Available

  • CIMeL

    Lanus, Buenos Aires B1824KAJ
    Argentina

    Site Not Available

  • CIMeL Clinical Research

    Lanus, Buenos Aires B1824KAJ
    Argentina

    Site Not Available

  • Centro de Investigaciones Médicas Mar del Plata

    Mar del Plata, Buenos Aires 7600
    Argentina

    Site Not Available

  • Policlinica Red OMIP

    Mar del Plata, Buenos Aires 7600
    Argentina

    Site Not Available

  • CIPREC

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1061AAS
    Argentina

    Site Not Available

  • Centro Médico Viamonte

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1120AAC
    Argentina

    Site Not Available

  • Instituto Centenario

    Caba, Ciudad Autónoma De Buenos Aires 1204
    Argentina

    Site Not Available

  • Consultorio de Investigación Clínica EMO SRL

    Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires 1405
    Argentina

    Site Not Available

  • Centro de Salud e Investigaciones Médicas

    Santa Rosa, La Pampa 6300
    Argentina

    Site Not Available

  • Fundacion Estudios Clinicos

    Rosario, Santa Fe S2000DEJ
    Argentina

    Site Not Available

  • INECO Neurociencias Oroño

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Instituto Especialidades de la Salud Rosario

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Instituto Médico Catamarca IMEC

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Instituto de Especialidades de la Salud Rosario

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clinicas Zarate

    Rosario, Santa Fe 2000
    Argentina

    Active - Recruiting

  • Instituto Médico DAMIC

    Córdoba, 5003DCE
    Argentina

    Site Not Available

  • Instituto de Investigaciones Clínicas Córdoba

    Córdoba, 5000
    Argentina

    Site Not Available

  • Sanatorio Norte

    Santiago del Estero, 4200
    Argentina

    Site Not Available

  • Beijing Pinggu District Hospital

    Beijing, Beijing 101200
    China

    Site Not Available

  • Chongqing General Hospital

    Chongqing, Chongqing 400014
    China

    Site Not Available

  • Shunde Hospital of Southern Medical Univesity

    Foshan, Guangdong 528399
    China

    Site Not Available

  • Huizhou Municipal Central Hospital

    Huizhou, Guangdong 516001
    China

    Site Not Available

  • The Fourth Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang, Henan 471003
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang Shi, Henan 471003
    China

    Site Not Available

  • Nanyang First People's Hospital

    Nanyang, Henan 473014
    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

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu 212000
    China

    Site Not Available

  • Jiangxi Pingxiang People's Hospital

    Pingxiang, Jiangxi 337055
    China

    Site Not Available

  • Dalian Municipal Central Hospital Affiliated of Dalian Medical University

    Dalian, Liaoning 116033
    China

    Site Not Available

  • Jinan Central Hospital

    Jinan, Shandong 250013
    China

    Site Not Available

  • Pudong New Area People's Hospital Shanghai

    Shanghai, Shanghai 201200
    China

    Site Not Available

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai 200030
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Cheng Du, Sichuan 610041
    China

    Site Not Available

  • West China Hospital of Sichuan University

    ChengDu, Sichuan 610041
    China

    Site Not Available

  • Chengdu Fifth People's Hospital

    Chengdu, Sichuan 611130
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan 650032
    China

    Site Not Available

  • Zhejiang Hospital

    Hangzhou, Zhejiang 310013
    China

    Site Not Available

  • Huzhou Central Hospital

    Huzhou, Zhejiang 313000
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

  • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism

    Matsuyama, Ehime 116099
    Japan

    Site Not Available

  • Manda Memorial Hospital

    Sapporo, Hokkaido 060-0062
    Japan

    Site Not Available

  • Nakamoto Internal Medicine Clinic

    Mito, Ibaraki 310-0826
    Japan

    Site Not Available

  • Nakakinen clinic

    Naka, Ibaraki 311-0113
    Japan

    Site Not Available

  • Ohishi Internal Medicine Clinic

    Tsuchiura, Ibaraki 300-0835
    Japan

    Site Not Available

  • Takai Internal Medicine Clinic

    Kamakura-shi, Kanagawa 247-0056
    Japan

    Site Not Available

  • Shiraiwa Medical Clinic

    Kashiwara, Osaka 582-0005
    Japan

    Site Not Available

  • Medical Corporation Sato Medical clinic

    Ootaku, Tokyo 143-0015
    Japan

    Site Not Available

  • Medical Corporation Sato Medical clinic

    Ōta, Tokyo 143-0015
    Japan

    Site Not Available

  • Gifu University Hospital

    Gifu, 501-1112
    Japan

    Site Not Available

  • AMC Nishiumeda Clinic

    Osaka, 530-0001
    Japan

    Site Not Available

  • CAIMED México

    Mexico City, Distrito Federal 06760
    Mexico

    Site Not Available

  • Caimed Investigacion En Salud S.A. de C.V.

    Mexico City, Distrito Federal 06760
    Mexico

    Site Not Available

  • Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares

    Mexico City, Distrito Federal 11650
    Mexico

    Site Not Available

  • CICEJ Centro de Investigación Clínica Endocrinológica de Jalisco S.C

    Guadalajara, Jalisco 44670
    Mexico

    Site Not Available

  • Centro de Investigacion Medica Integral

    Guadalajara, Jalisco 44160
    Mexico

    Site Not Available

  • Consultorio Médico

    Guadalajara, Jalisco 44210
    Mexico

    Site Not Available

  • Instituto Jalisciense de Investigacion en Diabetes y Obesidad

    Guadalajara, Jalisco 44600
    Mexico

    Site Not Available

  • Private Practice - Dr. Arechavaleta Granell Maria del Rosario

    Guadalajara, Jalisco 44670
    Mexico

    Site Not Available

  • Virgen Cardiovascular Research SC

    Guadalajara, Jalisco 44670
    Mexico

    Site Not Available

  • Centro de Investigacion Medica de Occidente, S.C.

    Zapopan, Jalisco 44260
    Mexico

    Site Not Available

  • Cardiolink Clin Trials

    Monterrey, Nuevo León 64060
    Mexico

    Site Not Available

  • Centro de investigación y control metabólico

    Monterrey, Nuevo León 66465
    Mexico

    Active - Recruiting

  • Clínica García Flores SC

    Monterrey, Nuevo León 64610
    Mexico

    Site Not Available

  • Eukarya PharmaSite

    Monterrey, Nuevo León 64718
    Mexico

    Site Not Available

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León 66460
    Mexico

    Site Not Available

  • Unidad biomedica avanzada monterrey

    Monterrey, Nuevo León 64460
    Mexico

    Site Not Available

  • Centro de investigación y control metabólico

    San Nicolás de los Garza, Nuevo León 66465
    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

  • Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia

    Durango, 34000
    Mexico

    Site Not Available

  • Isis Clinical Research Center

    Guaynabo, 00968
    Puerto Rico

    Site Not Available

  • Private Practice - Dr. Paola Mansilla-Letelier

    Guaynabo, 00968
    Puerto Rico

    Site Not Available

  • Research and Cardiovascular Corp.

    Ponce, 00717
    Puerto Rico

    Site Not Available

  • Endocrinologist Metabolic Clinic & Research Institute

    San Juan, 00921
    Puerto Rico

    Site Not Available

  • Latin Clinical Trial Center

    San Juan, 00909
    Puerto Rico

    Site Not Available

  • Mgcendo Llc

    San Juan, 00921
    Puerto Rico

    Site Not Available

  • Absolute Clinical Research

    Phoenix, Arizona 85051
    United States

    Site Not Available

  • San Fernando Valley Health Institute

    Canoga Park, California 91304
    United States

    Site Not Available

  • Neighborhood Healthcare Institute of Health

    Escondido, California 92025
    United States

    Site Not Available

  • Velocity Clinical Research, Gardena

    Gardena, California 90247
    United States

    Site Not Available

  • Biopharma Informatic

    Los Angeles, California 90035
    United States

    Site Not Available

  • Biopharma Informatic, LLC

    Los Angeles, California 90035
    United States

    Site Not Available

  • National Research Institute - Wilshire

    Los Angeles, California 90057
    United States

    Site Not Available

  • Velocity Clinical Research, Westlake

    Los Angeles, California 90057
    United States

    Site Not Available

  • Infinity Clinical Research - Norco

    Norco, California 92860
    United States

    Site Not Available

  • Valley Clinical Trials, Inc.

    Northridge, California 91325
    United States

    Site Not Available

  • Norcal Endocrinology & Internal Medicine

    San Ramon, California 94583
    United States

    Site Not Available

  • Encompass Clinical Research

    Spring Valley, California 91978
    United States

    Site Not Available

  • University Clinical Investigators, Inc.

    Tustin, California 92780
    United States

    Site Not Available

  • New West Physicians Clinical Research

    Golden, Colorado 80401
    United States

    Site Not Available

  • Connecticut Clinical Research - Cromwell

    Cromwell, Connecticut 06416
    United States

    Site Not Available

  • Clinical Research of West Florida, Inc. (Clearwater)

    Clearwater, Florida 33765
    United States

    Site Not Available

  • South Florida Clinical Research Institute

    Margate, Florida 33063
    United States

    Site Not Available

  • Miami Dade Medical Research Institute, LLC

    Miami, Florida 33176
    United States

    Site Not Available

  • West Orange Endocrinology

    Ocoee, Florida 34761
    United States

    Site Not Available

  • Latin Clinical Trial Center

    Tamarac, Florida 33321
    United States

    Site Not Available

  • Latin Clinical Trial Center Florida

    Tamarac, Florida 33321
    United States

    Site Not Available

  • Clinical Research of West Florida

    Tampa, Florida 33606
    United States

    Site Not Available

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • Balanced Life Health Care Solutions/SKYCRNG

    Lawrenceville, Georgia 30046
    United States

    Site Not Available

  • Clinical Research Atlanta

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • North Georgia Clinical Research

    Woodstock, Georgia 30189
    United States

    Site Not Available

  • Northwest Clinical Trials

    Boise, Idaho 83704
    United States

    Site Not Available

  • Family First Medical Center

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • American Health Network of IN, LLC

    Greenfield, Indiana 46140
    United States

    Site Not Available

  • American Health Network of Indiana, LLC - Greenfield

    Greenfield, Indiana 46140
    United States

    Site Not Available

  • Velocity Clinical Research, Valparaiso

    Valparaiso, Indiana 46383
    United States

    Site Not Available

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas 66606
    United States

    Site Not Available

  • Cotton O'Neil Diabetes & Endocrinology

    Topeka, Kansas 66606
    United States

    Site Not Available

  • Tekton Research - Wichita

    Wichita, Kansas 67218
    United States

    Site Not Available

  • Tekton Research, Inc

    Wichita, Kansas 67218
    United States

    Site Not Available

  • DelRicht Research

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Joslin Diabetes Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Revival Research Institute - Dearborn

    Dearborn, Michigan 48126
    United States

    Site Not Available

  • Revival Research Institute, LLC

    Dearborn, Michigan 48126
    United States

    Site Not Available

  • SKY Clinical Research Network Group-Quinn

    Ridgeland, Mississippi 39157
    United States

    Site Not Available

  • SKY Integrative Medical Center/SKYCRNG

    Ridgeland, Mississippi 39157
    United States

    Site Not Available

  • Kansas City Research Institute

    Kansas City, Missouri 64131
    United States

    Site Not Available

  • Glacier View Research Institute - Endocrinology

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Logan Health Research

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Wr-Crcn, Llc

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Premier Research

    Trenton, New Jersey 08611
    United States

    Site Not Available

  • Albany Medical College, Division of Community Endocrinology

    Albany, New York 12203
    United States

    Site Not Available

  • Ellipsis Research Group

    Brooklyn, New York 11215
    United States

    Site Not Available

  • Ellipsis Research Group - Brooklyn - 7th Street

    Brooklyn, New York 11215
    United States

    Site Not Available

  • Great Lakes Medical Research, LLC

    Westfield, New York 14787
    United States

    Site Not Available

  • PharmQuest

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • PharmQuest Life Sciences, LLC

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Lucas Research, Inc

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Accellacare - Piedmont

    Statesville, North Carolina 28625
    United States

    Site Not Available

  • Wake Forest University Baptist Medical Center (WFUBMC)

    Winston-Salem, North Carolina 27104
    United States

    Site Not Available

  • Aventiv Research Inc

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Tekton Research, Inc

    Moore, Oklahoma 73160
    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

    Site Not Available

  • The Corvallis Clinic, P.C.

    Corvallis, Oregon 97330
    United States

    Site Not Available

  • Heritage Valley Medical Group, Inc.

    Beaver, Pennsylvania 15009
    United States

    Site Not Available

  • Heritage Valley Multispecialty Group, Inc

    Beaver, Pennsylvania 15009
    United States

    Site Not Available

  • Office 18

    Pittsburgh, Pennsylvania 15236
    United States

    Site Not Available

  • Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)

    Pittsburgh, Pennsylvania 15236
    United States

    Site Not Available

  • The Research Center of The Upstate

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • New Phase Research and Development

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Clinical Neuroscience Solutions Inc.

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Velocity Clinical Research, Austin

    Austin, Texas 78759
    United States

    Site Not Available

  • DiscoveResearch

    Beaumont, Texas 77701
    United States

    Site Not Available

  • Velocity Clinical Research, Austin

    Cedar Park, Texas 78613
    United States

    Site Not Available

  • Dallas Diabetes Research Center

    Dallas, Texas 75230
    United States

    Site Not Available

  • Velocity Clinical Research, Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • Diabetes and Thyroid Center of Ft. Worth

    Fort Worth, Texas 76132
    United States

    Site Not Available

  • Clear Brook Medical Associates

    Houston, Texas 77089
    United States

    Site Not Available

  • Endocrine Ips, Pllc

    Houston, Texas 77079
    United States

    Site Not Available

  • Juno Research

    Houston, Texas 77040
    United States

    Site Not Available

  • Southern Endocrinology Associates

    Mesquite, Texas 75149
    United States

    Site Not Available

  • Texas Valley Clinical Research

    Weslaco, Texas 78596
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc.

    Salt Lake City, Utah 84106
    United States

    Site Not Available

  • Eastside Research Associates

    Redmond, Washington 98052
    United States

    Site Not Available

  • Rainier Clinical Research Center

    Renton, Washington 98057
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.