HealthyPhase 1NCT07566338
A Study of LY4302814 in Healthy Participants
A Phase 1 study testing LY4302814 in people with Healthy, run by Eli Lilly and Company at 2 sites in 2 countries.
Trial summary
The main purpose of this study is to assess how well LY4302814 is tolerated and what side effects may occur in healthy participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY4302814
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 May 2026to Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are overtly healthy as determined by medical evaluation.
- 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.
- Have a body weight of 45 kilograms (kg) or greater and body mass index within 18 to 32 kilogram per square meter (kg/m ²), inclusive.
- Are individuals assigned female at birth (AFAB) and not of childbearing potential, and individuals assigned male at birth (AMAB). Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Adult participants in Singapore:
- Are 21 years of age or older.
Who cannot join
- Evidence or history of clinically significant conditions.
- Have a 12-lead electrocardiogram (ECG) abnormality, that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis.
- Show evidence of hepatitis B virus (HBV) infection with a positive hepatitis B surface antigen (HBsAg) or anti-hepatitis B core (HBc).
- Show evidence of hepatitis C virus (HCV) infection, with positive anti-HCV.
- Have human immunodeficiency virus (HIV) infection or positive HIV-1 and HIV-2 antibodies.
- Have used or intend to use herbal, vitamin supplements, over-the-counter or prescription medication, within 14 days or 5 half-lives (whichever is longer) prior to dosing and during the study, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
- Smoke more than 5 cigarettes a day, or the equivalent in nicotine-containing products, and/or are unable to abide by clinical research unit (CRU) smoking restrictions.
- Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Fortrea Clinical Research Unit
Daytona Beach, Florida, 32117
866-429-3700
Chiamaka Iheme
Singapore1 site, 1 recruiting
- Recruiting
Lilly Centre for Clinical Pharmacology
Singapore, 138623
+65 6413 9832
Noel Varghese
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, Investigator and Participant Blinded, Single Ascending Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4302814 in Healthy Participants
The main purpose of this study is to assess how well LY4302814 is tolerated and what side effects may occur in healthy participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant, the study will last about 6 months and will include at least one overnight stay in the clinical research unit (CRU) lasting up to approximately 9 days.
- Conditions
- Healthy
- Being tested
- LY4302814, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4302814Drug
Administered SC
LY4302814Drug
Administered IV
PlaceboDrug
Administered SC
PlaceboDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| LY4302814 IV | Experimental | LY4302814 administered intravenously (IV) Receives: Drug: LY4302814 |
| Placebo IV | Placebo comparator | Placebo administered IV Receives: Drug: Placebo |
| LY4302814 SC | Experimental | LY4302814 administered subcutaneously (SC) Receives: Drug: LY4302814 |
| Placebo SC | Placebo comparator | Placebo administered SC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Measured: Day 1 through Day 197
Secondary outcomes (2)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4302814
Measured: Day 1 through Day 197
PK: Maximum Concentration (Cmax) of LY4302814
Measured: Day 1 through Day 197
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start6 May 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566338
- Sponsor's protocol ID
- 27809
- Other IDs
- J7A-MC-NGAA
- Status last verified
- Jun 2026
- First submitted
- 29 Apr 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled, Investigator and Participant Blinded, Single Ascending Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4302814 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07566338
- Acronym / sponsor ID
- 27809
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 6 May 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 5 May 2026 (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 assess how well LY4302814 is tolerated and what side effects may occur in healthy participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant, the study will last about 6 months and will include at least one overnight stay in the clinical research unit (CRU) lasting up to approximately 9 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LY4302814 IV | Experimental | Drug: LY4302814LY4302814 administered intravenously (IV) |
| Placebo IV | Placebo comparator | Drug: PlaceboPlacebo administered IV |
| LY4302814 SC | Experimental | Drug: LY4302814LY4302814 administered subcutaneously (SC) |
| Placebo SC | Placebo comparator | Drug: PlaceboPlacebo administered SC |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are overtly healthy as determined by medical evaluation.
- 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.
- Have a body weight of 45 kilograms (kg) or greater and body mass index within 18 to 32 kilogram per square meter (kg/m ²), inclusive.
- Are individuals assigned female at birth (AFAB) and not of childbearing potential, and individuals assigned male at birth (AMAB). Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Adult participants in Singapore:
Key exclusion criteria (8 listed)
- Evidence or history of clinically significant conditions.
- Have a 12-lead electrocardiogram (ECG) abnormality, that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis.
- Show evidence of hepatitis B virus (HBV) infection with a positive hepatitis B surface antigen (HBsAg) or anti-hepatitis B core (HBc).
- Show evidence of hepatitis C virus (HCV) infection, with positive anti-HCV.
- Have human immunodeficiency virus (HIV) infection or positive HIV-1 and HIV-2 antibodies.
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 |
|---|---|---|
| LY4302814Administered SC | Drug | LY4302814 SC |
| LY4302814Administered IV | Drug | LY4302814 IV |
| PlaceboAdministered SC | Drug | Placebo SC |
| PlaceboAdministered IV | Drug | Placebo IV |
Primary outcome
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Day 1 through Day 197
2 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4302814
Time frame: Day 1 through Day 197
PK: Maximum Concentration (Cmax) of LY4302814
Time frame: Day 1 through Day 197
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 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.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY4302814 in people with Healthy, run by Eli Lilly and Company at 2 sites in 2 countries.
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Day 1 through Day 197). 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 Jun 2026.