A Study of LY4065967 in Healthy Japanese Participants

Last updated: February 6, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Rosuvastatin

LY4065967

Placebo

Clinical Study ID

NCT06594159
18815
J4X-JE-LWCA
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to obtain safety and tolerability data of the study drug known as LY4065967 and rosuvastatin in healthy Japanese participants. Blood tests will be performed to check how much LY4065967 and rosuvastatin get into the bloodstream and how long it takes the body to eliminate it. This is a 3-part study and will last approximately 2 weeks excluding screening period for each part.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Japanese participants who are overtly healthy as determined by medical evaluationincluding medical history and physical examination

  • Have a body mass index within the range 18 to 30 kilogram per square meter (kg/m2)

  • Have a body weight of:

  • ≥ 40 kilograms (kg) for individuals assigned female at birth

  • ≥ 50 kg for individuals assigned male at birth

Exclusion

Exclusion Criteria:

  • Have a history or presence of medical illness including, but not limited to, anycardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric orneurological disease, or convulsions that, in the judgment of the investigator,indicate a medical problem that would preclude study participation

  • Have an abnormality in the 12-lead echocardiogram (ECG) that, in the opinion of theinvestigator, increases the risks associated with participating in the study

  • Have a history of clinically significant multiple or severe drug allergies or severeposttreatment hypersensitivity reactions, which in the opinion of the investigatormay hamper participation in the study

  • Show evidence of hepatitis C and/or have a positive hepatitis C virus antibody test

  • Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIVantigen and/or antibodies.

  • Show evidence of hepatitis B and/or positive hepatitis B surface antigen

  • Show evidence of syphilis or have a positive syphilis test.

  • Have an abnormal blood pressure (supine) as determined by the investigator

  • Are pregnant or intend to become pregnant or to breastfeed during the study.

  • Participants with a history of drug abuse which, in the opinion of the investigator,is clinically significant or who test positive for drugs of abuse at screening oradmission

  • Have alcohol intake that exceeds recommended average weekly alcohol consumptionlimits per local regulation, or an amount deemed significant by the investigator

  • Smoke more than 10 cigarettes per day or the equivalent including electroniccigarettes

  • Are unwilling to comply with the dietary restrictions required for this study

Study Design

Total Participants: 59
Treatment Group(s): 3
Primary Treatment: Rosuvastatin
Phase: 1
Study Start date:
October 22, 2024
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • Souseikai Fukuoka Mirai Hospital

    Fukuoka, 813-0017
    Japan

    Active - Recruiting

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