A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone

Last updated: April 21, 2025
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Diabetes Mellitus Types I And Ii

Diabetes Prevention

Diabetes And Hypertension

Treatment

Orforglipron

Placebo

Clinical Study ID

NCT05971940
18564
J2A-MC-GZGT
U1111-1290-5157
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to determine safety and efficacy of orforglipron compared with placebo in adult participants with type 2 diabetes and inadequate glycemic control with diet and exercise alone. The study will last approximately 54 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have Type 2 Diabetes

  • Have HbA1c ≥7.0% (53 mmol/mol) to ≤9.5% (80 mmol/mol) despite diet and exercisetreatment, as determined by the central laboratory at screening.

  • Are naïve to insulin therapy except for gestational diabetes or ≤14 days use foracute treatment and have not used any oral or injectable antihyperglycemicmedications during the 90 days preceding screening or between screening andrandomization.

  • Are of stable weight (±5%) for at least 90 days prior to screening and agree to notinitiate an intensive diet or exercise program during the study with the intent ofreducing body weight other than the lifestyle and/or dietary measures for diabetestreatment.

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

Exclusion

Exclusion Criteria:

  • Have Type 1 Diabetes

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

  • Currently receiving or planning to receive treatment for diabetic retinopathy and/ormacular edema

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

  • Have acute or chronic pancreatitis

Study Design

Total Participants: 559
Treatment Group(s): 2
Primary Treatment: Orforglipron
Phase: 3
Study Start date:
August 09, 2023
Estimated Completion Date:
April 03, 2025

Connect with a study center

  • Wannan Medical College Yijishan Hospital

    Wuhu, Anhui 241001
    China

    Site Not Available

  • Beijing Hospital

    Beijing, Beijing 100730
    China

    Site Not Available

  • Beijing Pinggu District Hospital

    Beijing, Beijing 101200
    China

    Site Not Available

  • Luhe Hospital

    Beijing, Beijing 100000
    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 Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Site Not Available

  • The Fourth Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Site Not Available

  • Nanyang First People's Hospital

    Nanyang, Henan 473001
    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

  • The Affiliated Hospital of Beihua University

    Jilin, Jilin 132000
    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

  • 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

  • B. J. Medical College & Civil Hospital

    Ahmedabad, Gujarat 380016
    India

    Site Not Available

  • GMERS Medical College and General Hospital

    Baroda, Gujarat 390021
    India

    Site Not Available

  • M S Ramaiah Medical College and Hospitals

    Bangalore, Karnataka 560054
    India

    Site Not Available

  • Medstar Speciality Hospital

    Bangalore, Karnataka 560092
    India

    Site Not Available

  • BSES MG Hospital

    Mumbai, Maharashtra 400058
    India

    Site Not Available

  • All India Institute of Medical Sciences (AIIMS) - Nagpur

    Nagpur, Maharashtra 441108
    India

    Site Not Available

  • Grant Medical Foundation - Ruby Hall Clinic

    Pune, Maharashtra 411001
    India

    Site Not Available

  • Madras Diabetes Research Foundation

    Chennai, Tamil Nadu 600086
    India

    Site Not Available

  • Kumudini Devi Diabetes Research Center

    Hyderabad, Telangana 500072
    India

    Site Not Available

  • Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital

    Kolkata, West Bengal 700020
    India

    Site Not Available

  • Tokuyama Clinic

    Chiba City, Chiba 261-0004
    Japan

    Site Not Available

  • Tokuyama Clinic

    Mihama-ku,Chiba City, Chiba 261-0004
    Japan

    Site Not Available

  • Steel Memorial Yahata Hospital

    Kitakyushu, Fukuoka 805-8508
    Japan

    Site Not Available

  • Steel Memorial Yawata Hospital

    Kitakyushu, Fukuoka 805-8508
    Japan

    Site Not Available

  • Hasegawa Medical Clinic

    Chitose, Hokkaido 066-0032
    Japan

    Site Not Available

  • MinamiAkatsukaClinic

    Mito, Ibaraki 311-4153
    Japan

    Site Not Available

  • Iwamoto Clinic

    Marugame, Kagawa 765-0071
    Japan

    Site Not Available

  • Iwamoto Clinic

    Zentsuji, Kagawa 765-0071
    Japan

    Site Not Available

  • Iwamoto Internal Medicine Clinic

    Zentsuji, Kagawa 765-0071
    Japan

    Site Not Available

  • Hayashi Diabetes Internal Medicine Clinic

    Chigasaki, Kanagawa 253-0044
    Japan

    Site Not Available

  • Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic

    Yamato-shi, Kanagawa 242-0004
    Japan

    Site Not Available

  • Medical Corporation Heishinkai OCROM Clinic

    Suita-shi, Osaka 565-0853
    Japan

    Site Not Available

  • Fukuwa Clinic

    Chuo-ku, Tokyo 104-0031
    Japan

    Site Not Available

  • The Institute for Adult Disease, Asahi Life Foundation

    Chuo-ku, Tokyo 103-0002
    Japan

    Site Not Available

  • The Institute of Medical Science, Asahi Life Foundation

    Chuo-ku, Tokyo 103-0002
    Japan

    Site Not Available

  • Tokyo-Eki Center-building Clinic

    Chuo-ku, Tokyo 103-0027
    Japan

    Site Not Available

  • Heishinkai Medical Group ToCROM Clinic

    Shinjuku-ku, Tokyo 160-0008
    Japan

    Site Not Available

  • Morinaga Ueno Clinic

    Kumamoto, 860-0863
    Japan

    Site Not Available

  • Abe Clinic

    Oita, 870-0039
    Japan

    Site Not Available

  • AMC Nishiumeda Clinic

    Osaka, 530-0001
    Japan

    Site Not Available

  • Centro de Investigacion Medica Integral

    Guadalajara, Jalisco 44160
    Mexico

    Site Not Available

  • Nucleo Medico la Paz

    Guadalajara, Jalisco 44860
    Mexico

    Site Not Available

  • Salud Cardiovascular

    Guadalajara, Jalisco 44860
    Mexico

    Site Not Available

  • Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente

    Guadalajara, Jalisco 44150
    Mexico

    Site Not Available

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

    Zapopan, Jalisco 44260
    Mexico

    Site Not Available

  • Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos

    Chihuahua, 31110
    Mexico

    Site Not Available

  • PanAmerican Clinical Research - Querétaro - Avenida Antea

    Querétaro, 76100
    Mexico

    Site Not Available

  • FAICIC S. de R.L. de C.V.

    Veracruz, 91900
    Mexico

    Site Not Available

  • Instituto Veracruzano en Investigación Clínica S.C.

    Veracruz, 91851
    Mexico

    Site Not Available

  • Puerto Rico Health Institute

    Dorado, 00646
    Puerto Rico

    Site Not Available

  • Advance Medical Research Center

    San Juan, 00926
    Puerto Rico

    Site Not Available

  • Syed Research Consultants Llc

    Sheffield, Alabama 35660
    United States

    Site Not Available

  • Aventiv Research

    Mesa, Arizona 85206
    United States

    Site Not Available

  • Epic Medical Research - Surprise

    Surprise, Arizona 85378
    United States

    Site Not Available

  • Quality of Life Medical & Research Center

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Neighborhood Healthcare Institute of Health

    Escondido, California 92025
    United States

    Site Not Available

  • National Research Institute - Huntington Park

    Huntington Park, California 90255
    United States

    Site Not Available

  • Velocity Clinical Research, Huntington Park

    Huntington Park, California 90255
    United States

    Site Not Available

  • Ark Clinical Research

    Long Beach, California 90815
    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

  • Norcal Endocrinology & Internal Medicine

    San Ramon, California 94583
    United States

    Site Not Available

  • University Clinical Investigators, Inc.

    Tustin, California 92780
    United States

    Site Not Available

  • Connecticut Clinical Research - Cromwell

    Cromwell, Connecticut 06416
    United States

    Site Not Available

  • Invictus Clinical Research Group

    Coconut Creek, Florida 33073
    United States

    Site Not Available

  • Hillcrest Medical Research

    DeLand, Florida 32720
    United States

    Site Not Available

  • K2 Medical Research

    Maitland, Florida 32751
    United States

    Site Not Available

  • Global Health Research Center, Inc.

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • West Orange Endocrinology

    Ocoee, Florida 34761
    United States

    Site Not Available

  • Clinical Research Atlanta

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia 30291
    United States

    Site Not Available

  • Family First Medical Center

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • American Health Network of IN, LLC

    Muncie, Indiana 47304
    United States

    Site Not Available

  • American Health Network of Indiana, LLC - Muncie

    Muncie, Indiana 47304
    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

  • Alliance for Multispecialty Research, LLC

    New Orleans, Louisiana 70119
    United States

    Site Not Available

  • Revival Research Institute

    Dearborn, Michigan 48126
    United States

    Site Not Available

  • Revival Research Institute - Dearborn

    Dearborn, Michigan 48126
    United States

    Site Not Available

  • Billings Clinic

    Billings, Montana 59101
    United States

    Site Not Available

  • Synexus Clinical Research US

    Henderson, Nevada 89052
    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

  • Central New York Clinical Research

    Manlius, New York 13104
    United States

    Site Not Available

  • Monroe Biomedical Research

    Monroe, North Carolina 28112
    United States

    Site Not Available

  • Lucas Research - New Bern

    New Bern, North Carolina 28562
    United States

    Site Not Available

  • Aventiv Research

    Dublin, Ohio 43016
    United States

    Site Not Available

  • Centricity Research Dublin Multispecialty

    Dublin, Ohio 43016
    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

  • Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair

    Pittsburgh, Pennsylvania 15243
    United States

    Site Not Available

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania 15401
    United States

    Site Not Available

  • The Research Center of The Upstate

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • MD First Research

    Lancaster, South Carolina 29720
    United States

    Site Not Available

  • MDFirst Research, LLC

    Lancaster, South Carolina 29720
    United States

    Site Not Available

  • The Jackson Clinic

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • DiscoveResearch

    Beaumont, Texas 77701
    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

  • Amir A Hassan, MD, PA

    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

  • Burke Internal Medicine and Research

    Burke, Virginia 22015
    United States

    Site Not Available

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