A Study of Once-Daily Oral Orforglipron (LY3502970) in Japanese Adult Participants With Obesity Disease

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

Phase

3

Condition

Obesity

Diabetes Prevention

Treatment

Orforglipron

Placebo

Clinical Study ID

NCT05931380
18744
J2A-JE-GZPD
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to investigate the efficacy and safety of oral orforglipron in participants with obesity disease with obesity-related health problems.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants with a BMI ≥27 kg/m² and <35 kg/m² and at least 2 obesity-relatedhealth problems (treated or untreated), OR a BMI ≥35 kg/m² and at least 1obesity-related health problem (treated or untreated). At least one obesity-relatedhealth problem should be hypertension, dyslipidemia or T2D (approximately 25% ofparticipants).

  • Have a history of at least one self-reported unsuccessful dietary effort to losebody weight.

  • Males and females may participate in this trial. Female participants must not bepregnant, intending to be pregnant, breastfeeding, or intending to breastfeed.

  • Contraceptive use by participants should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies.

  • No male contraception is required except in compliance with specific localgovernment study requirements.

Exclusion

Exclusion Criteria:

  • For participants with Type 2 Diabetes (T2D):

  • Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma,or any other types of diabetes except T2D.

  • Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode ofhypoglycemia unawareness within the 180 days prior to screening.

  • Have renal impairment measured as estimated glomerular filtration rate (eGFR) <15mL/min/1.73 m², calculated by Japanese Society of Nephrology coefficient-modifiedchronic kidney disease-epidemiology equation during screening.

  • Have a known clinically significant gastric emptying abnormality.

  • For participants without Type 2 diabetes (T2D): Have any type of diabetes withhemoglobin A1c (HbA1c) ≥6.5 %.

  • Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior toscreening.

  • Have chronic kidney disease.

  • Have lupus or rheumatoid arthritis.

  • Have the following cardiovascular conditions within 90 days prior to screening.

  • Have acute or chronic hepatitis.

Study Design

Total Participants: 236
Treatment Group(s): 2
Primary Treatment: Orforglipron
Phase: 3
Study Start date:
July 31, 2023
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Nishiyamadou Keiwa Hospital

    Naka, Ibaraki 311-0133
    Japan

    Site Not Available

  • Ohishi Internal Medicine Clinic

    Tsuchiura, Ibaraki 300-0835
    Japan

    Site Not Available

  • Tsuchiura Beryl Clinic

    Tsuchiura, Ibaraki 300-0062
    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 Higashirinkan Kaneshiro Diabetes Clinic

    Sagamihara, Kanagawa 252-0302
    Japan

    Site Not Available

  • Shiraiwa Medical Clinic

    Kashiwara, Osaka 582-0005
    Japan

    Site Not Available

  • Medical Corporation Heishinkai OCROM Clinic

    Suita-shi, Osaka 565-0853
    Japan

    Site Not Available

  • Sugiura Clinic

    Kawaguchi, Saitama 332-0012
    Japan

    Site Not Available

  • Yotsuya Medical Cube

    Chiyoda, Tokyo 102-0084
    Japan

    Site Not Available

  • Fukuwa Clinic

    Chuo-ku, Tokyo 104-0031
    Japan

    Site Not Available

  • Nihonbashi Sakura Clinic

    Chuo-ku, Tokyo 103-0025
    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

  • Medical Corporation Heishinkai ToCROM Clinic

    Shinjuku-ku, Tokyo 160-0008
    Japan

    Active - Recruiting

  • Hiroshima Station Clinic

    Hiroshima, 732-0053
    Japan

    Site Not Available

  • AMC Nishiumeda Clinic

    Osaka, 530-0001
    Japan

    Site Not Available

  • Osaka Nishiumeda Clinic

    Osaka, 530-0001
    Japan

    Site Not Available

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