A Study of LY3841136 in Japanese Participants With Obesity or Overweight

Last updated: April 17, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Not Recruiting

Phase

1

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

Tirzepatide

LY3841136

Tirzepatide-Placebo

Clinical Study ID

NCT06297616
18814
J3R-JE-YDAB
  • Ages 18-65
  • All Genders

Study Summary

The main purpose of this study is to learn about the side effects of LY3841136 alone and in combination with tirzepatide, when given to Japanese participants with obese or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Part A of the study will last about 28 weeks and may include up to 17 visits. Part B of the study will last about 40 weeks and may include up to 29 visits.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female participants who agree to contraception requirements

  • Have a body mass index (BMI) within the range of 27 to 40 kg/m², inclusive

  • Have had a stable weight for the 3 months

Exclusion

Exclusion Criteria:

  • Have a history of significant atopy (severe allergic manifestations), multiple orsevere drug allergies, or severe posttreatment hypersensitivity reactions

  • Have a history or presence of psychiatric disorders, including a history of majordepressive disorder or severe psychiatric disorders such as schizophrenia, bipolardisorder within the last 3 years

  • Have been diagnosed with Type 1 or Type 2 Diabetes Mellitus

  • Have a history of chronic medical conditions involving the heart, liver, or kidneys

  • Have a history of any malignancy within the past 5 years

  • Have a history or presence of a GI disorder

  • Have had within the last 6 months, or plan to have during the study, a device-basedor surgical treatment use for obesity

  • Have been treated, or plan to be treated, with prescription medications or othernon-approved drugs intended to promote weight loss, within 3 months prior toscreening

  • For participants in Part B, have previously received tirzepatide within 6 monthsprior to screening

  • For participants in Part B, have a personal or family history of medullary thyroidcarcinoma, or have multiple endocrine neoplasia syndrome type 2

Study Design

Total Participants: 128
Treatment Group(s): 5
Primary Treatment: Tirzepatide
Phase: 1
Study Start date:
April 15, 2024
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • P-One Clinic

    Hachioji, Tokyo 192-0071
    Japan

    Site Not Available

  • Sumida Hospital

    Sumida-ku, Tokyo 130-0004
    Japan

    Site Not Available

  • Hakata Clinic

    Fukuoka, 812-0025
    Japan

    Site Not Available

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