A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor

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

Orforglipron

Placebo

Clinical Study ID

NCT06109311
18567
2023-507280-18-00
J2A-MC-GZGW
U1111-1294-2797
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to determine the safety and efficacy of orforglipron. Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor. The study will last about 46 weeks and may include up to 20 visits.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have Type 2 Diabetes (T2D)

  • Have HbA1c ≥7.0% [53 mmol/mol] to ≤10.5% [91 mmol/mol]

  • Have been treated with stable doses of the same formulation of the following for ≥90days prior to screening visit 1 and have maintained the same doses throughrandomization:

  • insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD (units per kilogram per day) or ≥20 U/QD alone, or

  • insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD or ≥20 U/QD in combination with

  • metformin, or

  • SGLT-2 inhibitor, or

  • both metformin and SGLT-2 inhibitor.

  • Are of stable body weight (±5%) for at least 90 days prior to screening visit 1 andagree to not initiate an intensive diet or exercise program during the study withthe intent of reducing body weight, other than the lifestyle and/or dietary measuresfor diabetes treatment.

  • Have a Body Mass Index (BMI) ≥23.0 kg/m^2 at baseline.

Exclusion

Exclusion Criteria:

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

  • Have had any of the following cardiovascular conditions within 60 days prior tobaseline.

  • acute myocardial infarction

  • cerebrovascular accident (stroke), or

  • hospitalization for congestive heart failure.

  • Have acute or chronic hepatitis, including a history of autoimmune hepatitis, signsor symptoms of any other liver disease other than nonalcoholic fatty liver disease

  • Have had chronic or acute pancreatitis any time.

Study Design

Total Participants: 520
Treatment Group(s): 2
Primary Treatment: Orforglipron
Phase: 3
Study Start date:
November 10, 2023
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • L2IP - Instituto de Pesquisas Clínicas

    Brasília, Distrito Federal 70200730
    Brazil

    Site Not Available

  • L2IP - Instituto de Pesquisas Clínicas - FC072920211954380192

    Brasília, Distrito Federal 70200730
    Brazil

    Active - Recruiting

  • CEDOES

    Vitória, Espírito Santo 29055450
    Brazil

    Site Not Available

  • Pesquisa Clínica em Diabetes - Dra Rosângela Réa

    Curitiba, Paraná 80040-110
    Brazil

    Active - Recruiting

  • Quanta Diagnóstico e Terapia

    Curitiba, Paraná 80040-110
    Brazil

    Site Not Available

  • Insight Centro de Pesquisas

    Porto Alegre, Rio Grande Do Sul 90560-003
    Brazil

    Site Not Available

  • Centro de Pesquisa Sao Lucas

    Campinas, São Paulo 13060-803
    Brazil

    Site Not Available

  • Centro Multidisciplinar de Estudos Clinicos

    Sao Bernardo do Campo, São Paulo 09715-090
    Brazil

    Site Not Available

  • ISPEM - Instituto São José dos Campos em Pesquisas Médicas

    São José dos Campos, São Paulo 12243-280
    Brazil

    Site Not Available

  • IBPClin - Instituto Brasil de Pesquisa Clínica

    Rio de Janeiro, 20241-180
    Brazil

    Site Not Available

  • CPQuali Pesquisa Clínica

    São Paulo, 01228-000
    Brazil

    Site Not Available

  • The Second People's Hospital of Hefei

    Hefei, Anhui 230011
    China

    Site Not Available

  • Wannan Medical College Yijishan Hospital

    Wuhu, Anhui 241001
    China

    Site Not Available

  • Beijing Hospital

    Beijing, Beijing 100051
    China

    Site Not Available

  • Chongqing General Hospital

    Chongqing, Chongqing 401147
    China

    Site Not Available

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

    Luoyang Shi, Henan 471003
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450014
    China

    Site Not Available

  • Nanjing First Hospital

    Nanjing, Jiangsu 210012
    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

  • Jinan Central Hospital

    Jinan, Shandong 250013
    China

    Site Not Available

  • Tokuyama Clinic

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

    Site Not Available

  • Hasegawa Medical Clinic

    Chitose, Hokkaido 066-0032
    Japan

    Site Not Available

  • MinamiAkatsukaClinic

    Mito, Ibaraki 311-4153
    Japan

    Site Not Available

  • Matoba Internal Medicine Clinic

    Ebina, Kanagawa 243-0432
    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

  • 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

  • Medical Corporation Sato Medical clinic

    Ootaku, Tokyo 143-0015
    Japan

    Site Not Available

  • Tama Center Clinic Mirai

    Tama, Tokyo 206-0633
    Japan

    Site Not Available

  • Jinnouchi Hospital

    Kumamoto, 862-0976
    Japan

    Site Not Available

  • Abe Clinic

    Oita, 870-0039
    Japan

    Site Not Available

  • Kansai Electric Power Hospital

    Osaka, 553-0003
    Japan

    Site Not Available

  • Centro de Endocrinologia y Nutricion

    Caguas, 00725
    Puerto Rico

    Site Not Available

  • FDI Clinical Research

    San Juan, 00927
    Puerto Rico

    Site Not Available

  • Diabdana

    Oradea, Bihor 410147
    Romania

    Site Not Available

  • C.M.D.T.A. Neomed

    Brasov, Brașov 500283
    Romania

    Site Not Available

  • Centrul Medical Endocrinologie si Diabet Dr. Paveliu

    Bucharest, București 50538
    Romania

    Site Not Available

  • Centrul Medical NutriLife

    Bucharest, București 013764
    Romania

    Site Not Available

  • Geea Medical Easy Diet

    Bucharest, București 010627
    Romania

    Site Not Available

  • CMI DNBM Dr. Pop Lavinia

    Baia Mare, Maramureș 430222
    Romania

    Site Not Available

  • SC Dentosim Queen SRL - Centrul Medical Diamed

    Târgu Mureș, Mureș 540098
    Romania

    Site Not Available

  • Diamed Obesity

    Galați, 800291
    Romania

    Site Not Available

  • Milena Sante

    Galați, 800001
    Romania

    Site Not Available

  • Clinica Korall

    Satu Mare, 440055
    Romania

    Site Not Available

  • MD First Research - Chandler

    Chandler, Arizona 85286
    United States

    Site Not Available

  • Phoenix Clinical LLC

    Phoenix, Arizona 85014
    United States

    Site Not Available

  • SanRo Clinical Research Group

    Bryant, Arkansas 72022
    United States

    Site Not Available

  • Velocity Clinical Research, Gardena

    Gardena, California 90247
    United States

    Site Not Available

  • Loma Linda University Health System

    Loma Linda, California 92350
    United States

    Site Not Available

  • Western University of Health Sciences

    Pomona, California 91766
    United States

    Site Not Available

  • Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.

    Toluca Lake, California 91602
    United States

    Site Not Available

  • CMR of Greater New Haven

    Hamden, Connecticut 06517
    United States

    Site Not Available

  • CMR of Greater New Haven, LLC

    Hamden, Connecticut 06517
    United States

    Site Not Available

  • Care Access - Brandon

    Brandon, Florida 33510
    United States

    Site Not Available

  • Encore Medical Research

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Encore Medical Research - Weston

    Weston, Florida 33331
    United States

    Site Not Available

  • Orita Clinical Research

    Decatur, Georgia 30034
    United States

    Site Not Available

  • Balanced Life Health Care Solutions/SKYCRNG

    Lawrenceville, Georgia 30046
    United States

    Site Not Available

  • Bingham Memorial Hospital

    Blackfoot, Idaho 83221
    United States

    Site Not Available

  • Humphreys Diabetes Center

    Boise, Idaho 83702
    United States

    Active - Recruiting

  • St. Luke's Humphreys Diabetes Center: Boise

    Boise, Idaho 83702
    United States

    Site Not Available

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas 66606
    United States

    Active - Recruiting

  • Cotton O'Neil Diabetes & Endocrinology

    Topeka, Kansas 66606
    United States

    Site Not Available

  • The Research Group of Lexington

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Clinvest Headlands Llc

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Clinvest Research LLC

    Springfield, Missouri 65807
    United States

    Active - Recruiting

  • Richmond University Medical Center

    Staten Island, New York 10310
    United States

    Site Not Available

  • Velocity Clinical Research, Mt. Auburn

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Velocity Clinical Research, Medford

    Medford, Oregon 97504
    United States

    Site Not Available

  • Tristar Clinical Investigations

    Philadelphia, Pennsylvania 19114
    United States

    Site Not Available

  • Frontier Clinical Research, LLC

    Scottdale, Pennsylvania 15683
    United States

    Site Not Available

  • Lifedoc Research - Lenox Park Drive

    Memphis, Tennessee 38115
    United States

    Site Not Available

  • Consano Clinical Research, LLC

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • Texas Valley Clinical Research

    Weslaco, Texas 78596
    United States

    Site Not Available

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