HealthyPhase 1NCT07247357
A Study of LY4064809 in Healthy Adult Chinese Participants
A Phase 1 study testing LY4064809 in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
Trial summary
The main purpose of this study is to measure how much LY4064809 gets into the bloodstream and how long it takes the body to eliminate it in healthy participants. It also looks at safety and tolerability in healthy participants. The study drug will be administered orally. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY4064809
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSingapore
- Study dates
- 24 Oct 2025to 16 Dec 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are native Chinese. To qualify as a native Chinese for the purpose of this study, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China
- Are overtly healthy as determined by medical evaluation, including medical history, physical examination, vital signs, and electrocardiogram (ECG) at screening and admission
- Have clinical laboratory test results within the normal range for the population or investigative site, or with abnormalities deemed not clinically significant by the investigator at screening
- Have a body mass index within the range 18 to 32 kilogram per square meter (kg/m²)
Who cannot join
- History or presence of any of the following conditions, deemed clinically significant by the investigator (or designee), which may significantly alter the absorption, metabolism, or elimination of drugs, constitute a risk when taking the study intervention, or interfere with the data interpretation:
- metabolic disease, including congenital non-hemolytic hyperbilirubinemia, for example, Gilbert syndrome
- bile duct disease, including removal of the gall bladder
- digestive system disease
- blood disease
- disease of the nervous system
Show all 12Show fewer
- significant history of, or presence of, liver disease, including any abnormal liver function tests, as defined by aspartate aminotransferase, alanine transaminase, or transducin beta-like above the 1.5× upper limit of normal range per the laboratory's reference ranges at screening, or
- clinically significant, active cardiovascular disease or history of heart attack within 6 months prior to the planned start of LY4064809
- Have a 12-lead ECG abnormality at screening or admission
- History of a major surgical procedure within 30 days prior to screening
- Diagnosed or treated cancer within 5 years prior to screening
- Have known allergies to LY4064809 or related compounds
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label Study of the Pharmacokinetics of LY4064809 in Healthy Adult Chinese Participants
The main purpose of this study is to measure how much LY4064809 gets into the bloodstream and how long it takes the body to eliminate it in healthy participants. It also looks at safety and tolerability in healthy participants. The study drug will be administered orally. The study will last approximately 21 days, excluding screening.
- Conditions
- Healthy
- Being tested
- LY4064809
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4064809Drug
administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY4064809 | Experimental | LY4064809 administered orally Receives: Drug: LY4064809 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4064809
PK: Cmax of LY4064809
Measured: Predose on Day 1 Through Day 14
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4064809
PK: AUC of LY4064809
Measured: Predose on Day 1 Through Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start24 Oct 2025
- Primary completion16 Dec 2025
- Study completion16 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247357
- Sponsor's protocol ID
- 27745
- Other IDs
- J6M-MC-JSGE
- Status last verified
- Jan 2026
- First submitted
- 18 Nov 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study of the Pharmacokinetics of LY4064809 in Healthy Adult Chinese Participants
- ClinicalTrials.gov ID
- NCT07247357
- Acronym / sponsor ID
- 27745
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to measure how much LY4064809 gets into the bloodstream and how long it takes the body to eliminate it in healthy participants. It also looks at safety and tolerability in healthy participants. The study drug will be administered orally. The study will last approximately 21 days, excluding screening.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LY4064809 | Experimental | Drug: LY4064809LY4064809 administered orally |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Are native Chinese. To qualify as a native Chinese for the purpose of this study, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China
- Are overtly healthy as determined by medical evaluation, including medical history, physical examination, vital signs, and electrocardiogram (ECG) at screening and admission
- Have clinical laboratory test results within the normal range for the population or investigative site, or with abnormalities deemed not clinically significant by the investigator at screening
- Have a body mass index within the range 18 to 32 kilogram per square meter (kg/m²)
Key exclusion criteria (12 listed)
- History or presence of any of the following conditions, deemed clinically significant by the investigator (or designee), which may significantly alter the absorption, metabolism, or elimination of drugs, constitute a risk when taking the study intervention, or interfere with the data interpretation:
- Have a 12-lead ECG abnormality at screening or admission
- History of a major surgical procedure within 30 days prior to screening
- Diagnosed or treated cancer within 5 years prior to screening
- Have known allergies to LY4064809 or related compounds
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY4064809administered orally | Drug | LY4064809 |
Primary outcome
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4064809
Time frame: Predose on Day 1 Through Day 14
PK: Cmax of LY4064809
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4064809
Time frame: Predose on Day 1 Through Day 14
PK: AUC of LY4064809
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY4064809 in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
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 4 inclusion and 12 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 16 Jan 2026. 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 Singapore. 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. 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?
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4064809 (time frame: Predose on Day 1 Through Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2026.