A Study of LY4065967 in Healthy Japanese Participants

March 31, 2025 updated by: Eli Lilly and Company

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: clinical_inquiry_hub@lilly.com

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: Baseline to 7 Days
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
Time Frame: Baseline to 12 Days
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
Time Frame: Predose on Day 1 Through 72 Hours Post-Dose
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
Time Frame: Predose on Day 1 Through 72 Hours Post-Dose
Part D: PK: AUC of Rosuvastatin
Predose on Day 1 Through 72 Hours Post-Dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part A : Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967
Time Frame: Predose on Day 1 Through 48 Hours Post-Dose
Part A: PK: Cmax of LY4065967
Predose on Day 1 Through 48 Hours Post-Dose
Part B: PK: Cmax of LY4065967
Time Frame: Predose on Day 1 Through Day 9
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
Time Frame: Predose on Day 1 Through 48 Hours Post-Dose
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
Time Frame: Day 5 Through Day 11
Part D: PK: Cmax of LY4065967
Day 5 Through Day 11
Part D: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4065967
Time Frame: Day 5 Through Day 11
Part D: PK: AUC of LY4065967
Day 5 Through Day 11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 11, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 11, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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