A Study of LY4065967 in Healthy Japanese Participants

A Phase 1 Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of LY4065967, to Evaluate the Effect of LY4065967 on the Pharmacokinetics of Rosuvastatin in Healthy Japanese Participants

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Rosuvastatin; Drug: LY4065967

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 813-0017
    • SOUSEIKAI Fukuoka Mirai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Japanese participants who are overtly healthy as determined by medical evaluation including 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 Criteria:

• Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological 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 the investigator, increases the risks associated with participating in the study
• Have a history of clinically significant multiple or severe drug allergies or severe posttreatment hypersensitivity reactions, which in the opinion of the investigator may 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 HIV antigen 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 or admission
• Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator
• Smoke more than 10 cigarettes per day or the equivalent including electronic cigarettes
• Are unwilling to comply with the dietary restrictions required for this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY4065967 Part A; A single dose of LY4065967 administered orally	Drug: LY4065967; Administered orally
Placebo Comparator: Placebo Part A; Placebo administered orally	Drug: Placebo; Administered orally
Experimental: LY4065967 Part B; Multiple doses of LY4065967 administered orally	Drug: LY4065967; Administered orally
Placebo Comparator: Placebo Part B; Placebo administered orally	Drug: Placebo; Administered orally
Experimental: LY4065967 and Rosuvastatin Part D; LY4065967 and Rosuvastatin administered orally	Drug: Rosuvastatin; Administered orally; Drug: LY4065967; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered to be Related to Study Drug Administration	Part A: A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module	Baseline to 7 Days
Part B: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered to be Related to Study Drug Administration	Part B: A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module	Baseline to 12 Days
Part D: PK: Maximum Concentration (Cmax) of Rosuvastatin	Part D: PK: Cmax of Rosuvastatin	Predose on Day 1 Through 72 Hours Post-Dose
Part D: PK: Area Under the Concentration Versus Time Curve (AUC) of Rosuvastatin	Part D: PK: AUC of Rosuvastatin	Predose on Day 1 Through 72 Hours Post-Dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A : Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967	Part A: PK: Cmax of LY4065967	Predose on Day 1 Through 48 Hours Post-Dose
Part B: PK: Cmax of LY4065967	Part B: PK: Cmax of LY4065967	Predose on Day 1 Through Day 9
Part A and B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4065967	Part A and B: PK: AUC of LY4065967	Predose on Day 1 Through 48 Hours Post-Dose
Part D: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967	Part D: PK: Cmax of LY4065967	Day 5 Through Day 11
Part D: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4065967	Part D: PK: AUC of LY4065967	Day 5 Through Day 11

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2024
• Primary Completion (Actual): March 11, 2025
• Study Completion (Actual): March 11, 2025

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: September 10, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: 18815; J4X-JE-LWCA (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes