A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes

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

Phase

3

Condition

Diabetes Mellitus Types I And Ii

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Treatment

Orforglipron

Clinical Study ID

NCT06010004
18745
J2A-JE-GZPE
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to determine the long-term safety of the study intervention orforglipron as a monotherapy or in combination with oral antihyperglycemic medication.

This study includes 3 periods as follows:

  • screening and lead-in period: up to 4 weeks

  • treatment period: 52 weeks, including 20 weeks of dose escalation, and

  • safety follow-up period: 2 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have Type 2 Diabetes (T2D)

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

  • 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 BMI ≥23.0 kilogram/square meter (kg/m²) at screening.

Exclusion

Exclusion Criteria:

  • Have Type 1 Diabetes (T1D).

  • Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6months prior to screening, or between screening and randomization.

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

  • Have had any of the following cardiovascular (CV) conditions within 60 days prior toscreening, or between screening and randomization.

  • acute myocardial infarction

  • cerebrovascular accident (stroke), or

  • hospitalization for congestive heart failure

  • Have acute or chronic hepatitis and pancreatitis

Study Design

Total Participants: 399
Treatment Group(s): 1
Primary Treatment: Orforglipron
Phase: 3
Study Start date:
September 28, 2023
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Nakayama Clinic

    Nagoya, Aichi 456-0058
    Japan

    Site Not Available

  • Kashiwa City Hospital

    Kashiwa, Chiba 277-0825
    Japan

    Site Not Available

  • Shinkashiwa Clinic

    Kashiwa, Chiba 277-0084
    Japan

    Site Not Available

  • Tokuyama Clinic

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

    Site Not Available

  • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism

    Matsuyama, Ehime 790-0034
    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

  • Odori Diabetes

    Sapporo, Hokkaido 060-0001
    Japan

    Site Not Available

  • Matsuda Clinic

    Kobe, Hyogo 651-2135
    Japan

    Site Not Available

  • MinamiAkatsukaClinic

    Mito, Ibaraki 311-4153
    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

  • Nishiyamadou Keiwa Hospital

    Naka, Ibaraki 311-0133
    Japan

    Site Not Available

  • Taya Clinic Koueikai Medical Corporation

    Tsuchiura, Ibaraki 300-0047
    Japan

    Site Not Available

  • Shonan Takai Clinic

    Kamakura, Kanagawa 247-0055
    Japan

    Site Not Available

  • Takai Internal Medicine Clinic

    Kamakura-shi, Kanagawa 247-0056
    Japan

    Site Not Available

  • Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic

    Yamato-shi, Kanagawa 242-0004
    Japan

    Site Not Available

  • Yokohama Minoru Clinic

    Yokohama, Kanagawa 232-0064
    Japan

    Site Not Available

  • Yokkaichi Diabetes Clinic

    Yokkaichi, Mie 510-0829
    Japan

    Site Not Available

  • Gibo Hepatology Clinic

    Matsumoto, Nagano 399-0036
    Japan

    Site Not Available

  • Shiraiwa Medical Clinic

    Kashiwara, Osaka 582-0005
    Japan

    Site Not Available

  • Kitada Clinic

    Osaka-city, Osaka 538-0044
    Japan

    Site Not Available

  • Medical Corporation Heishinkai OCROM Clinic

    Suita-shi, Osaka 565-0853
    Japan

    Site Not Available

  • OHAMA Diabetes Clinic

    Kawaguchi, Saitama 332-0015
    Japan

    Site Not Available

  • Sugiura Internal Medicine Clinic

    Soka, Saitama 340-0015
    Japan

    Site Not Available

  • Seiwa Clinic

    Adachi-ku, Tokyo 120-0011
    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

  • Hachioji Diabetes Clinic

    Hachioji-shi, Tokyo 192-0083
    Japan

    Site Not Available

  • Kanno Naika

    Mitaka, Tokyo 181-0013
    Japan

    Site Not Available

  • Heishinkai Medical Group ToCROM Clinic

    Shinjuku-ku, Tokyo 160-0008
    Japan

    Site Not Available

  • Medical Corporation Heishinkai ToCROM Clinic

    Shinjuku-ku, Tokyo 160-0008
    Japan

    Site Not Available

  • Fujii Clinic

    Ube, Yamaguchi 755-0049
    Japan

    Site Not Available

  • Medical Corporation Tao Internal Medicine Clinic

    Ube, Yamaguchi 755-0047
    Japan

    Site Not Available

  • Tokuyama Clinic

    Chiba, 261-0004
    Japan

    Site Not Available

  • Tashiro Endocrinology Clinic

    Fukuoka, 814-0153
    Japan

    Site Not Available

  • Jinnouchi Hospital

    Kumamoto, 862-0976
    Japan

    Site Not Available

  • Morinaga Ueno Clinic

    Kumamoto, 860-0863
    Japan

    Site Not Available

  • Heiwadai Hospital

    Miyazaki, 880-0034
    Japan

    Site Not Available

  • Abe Clinic

    Oita, 870-0039
    Japan

    Site Not Available

  • AMC Nishiumeda Clinic

    Osaka, 530-0001
    Japan

    Active - Recruiting

  • Kansai Electric Power Hospital

    Osaka, 553-0003
    Japan

    Site Not Available

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