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HealthyPhase 1NCT06594159

A Study of LY4065967 in Healthy Japanese Participants

A Phase 1 study testing LY4065967 and Rosuvastatin in people with Healthy, run by Eli Lilly and Company at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
LY4065967 and Rosuvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
59 participants
Where
1 siteJapan
Study dates
22 Oct 2024to 11 Mar 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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 all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Souseikai Fukuoka Mirai Hospital

    Fukuoka, 813-0017

Other trials in Japan

About this study

Official title: 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.

Conditions
Healthy
Being tested
LY4065967, Placebo, Rosuvastatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY4065967Drug

    Administered orally

  • PlaceboDrug

    Administered orally

  • RosuvastatinDrug

    Administered orally

Study groups in NCT06594159
Study groupRoleWhat they receive
LY4065967 Part AExperimentalA single dose of LY4065967 administered orally
Receives: Drug: LY4065967
Placebo Part APlacebo comparatorPlacebo administered orally
Receives: Drug: Placebo
LY4065967 Part BExperimentalMultiple doses of LY4065967 administered orally
Receives: Drug: LY4065967
Placebo Part BPlacebo comparatorPlacebo administered orally
Receives: Drug: Placebo
LY4065967 and Rosuvastatin Part DExperimentalLY4065967 and Rosuvastatin administered orally
Receives: Drug: LY4065967; Drug: Rosuvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline to 7 Days

  2. 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

    Measured: Baseline to 12 Days

  3. Part D: PK: Maximum Concentration (Cmax) of Rosuvastatin

    Part D: PK: Cmax of Rosuvastatin

    Measured: Predose on Day 1 Through 72 Hours Post-Dose

  4. Part D: PK: Area Under the Concentration Versus Time Curve (AUC) of Rosuvastatin

    Part D: PK: AUC of Rosuvastatin

    Measured: Predose on Day 1 Through 72 Hours Post-Dose

Secondary outcomes (5)

  1. Part A : Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967

    Part A: PK: Cmax of LY4065967

    Measured: Predose on Day 1 Through 48 Hours Post-Dose

  2. Part B: PK: Cmax of LY4065967

    Part B: PK: Cmax of LY4065967

    Measured: Predose on Day 1 Through Day 9

  3. Part A and B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4065967

    Part A and B: PK: AUC of LY4065967

    Measured: Predose on Day 1 Through 48 Hours Post-Dose

  4. Part D: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4065967

    Part D: PK: Cmax of LY4065967

    Measured: Day 5 Through Day 11

  5. Part D: PK: Area Under the Concentration Versus Time Curve (AUC) of LY4065967

    Part D: PK: AUC of LY4065967

    Measured: Day 5 Through Day 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start22 Oct 2024
  3. Primary completion11 Mar 2025
  4. Study completion11 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06594159
Sponsor's protocol ID
18815
Other IDs
J4X-JE-LWCA
Status last verified
Mar 2025
First submitted
10 Sep 2024
Last updated
3 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY4065967 and Rosuvastatin in people with Healthy, run by Eli Lilly and Company at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06594159.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.

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