Healthy VolunteersPhase 1NCT07698210
A Study of LY4178256 in Healthy Participants
A Phase 1 study testing LY4178256 in people with Healthy Volunteers, run by Eli Lilly and Company at 2 sites in United States.
Trial summary
The main purpose of this study is to evaluate how well LY4178256 is tolerated and what side effects may occur in healthy participants. Blood tests will be performed to check how much LY4178256 gets 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 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- LY4178256
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jul 2026to Mar 2028
- 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 including medical history, physical examination, and other screening procedures.
- Have a body mass index within the range of 19.0 to 32.0 kilograms per square meter (kg/m²)
- Individuals assigned male at birth willing to practice effective contraception throughout the study and individuals assigned female at birth not of childbearing potential may participate in this trial.
Who cannot join
- Have significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the Investigational Medicinal Product (IMP); or of interfering with the interpretation of data.
- Have abnormal blood pressure
- Have a 12-lead electrocardiogram (ECG) abnormality at screening that, in the opinion of the investigator, increases the risks associated with participating in the study, have a mean QT interval corrected using Fridericia's formula (QTcF) of greater than 450 milliseconds (>450 msec) for males, or >470 msec for females.
- Regularly use known drugs of abuse or with positive drug results (within the past 3 months).
- Have a positive ethanol breath/urine test result or positive urine drugs of abuse screen at screening or check-in.
- Have hemoglobin level less than 12 grams per deciliter (<12 g/dL), or evidence of iron deficiency (ferritin less than 30 nanograms per milliliter (<30 ng/mL), or history or presence of hemoglobinopathy, or history hemolytic anemia. Participants who received transfusion within the past 12 weeks, or requiring regular transfusion should be excluded.
- Have clinically significant abnormal liver function tests at screening: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphate (ALP), or total bilirubin ≥1.5x upper limit normal (ULN). Participants with confirmed Gilbert's syndrome may be enrolled.
- Have significant renal impairment (estimated glomerular filtration rate less than 60 milliliters per minute per square meter (eGFR<60mL/min/1.73 m ²)).
Trial locations and contacts
2 sites in 1 country. 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
United States2 sites, 2 recruiting
- Not yet recruiting
Collaborative Neuroscience Network - CNS
Los Alamitos, California, 90720
844-424-9494
Steven Reynolds
- Recruiting
ICON
Salt Lake City, Utah, 84124
801-904-4600
Ahad Sabet
About this study
Official title: A Phase 1, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4178256 in Healthy Participants
The main purpose of this study is to evaluate how well LY4178256 is tolerated and what side effects may occur in healthy participants. Blood tests will be performed to check how much LY4178256 gets into the bloodstream and how long it takes the body to eliminate it. For each participant, the study will last about 7 months and will include either 7 or 12 visits depending on the assigned treatment.
- Conditions
- Healthy Volunteers
- Being tested
- LY4178256, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4178256Drug
Administered intravenously (IV)
PlaceboDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| LY4178256 Part A: Single-Ascending Dose (SAD) (Cohorts 1-6b) | Experimental | LY4178256 or Placebo administered Intravenously (IV) Receives: Drug: LY4178256; Drug: Placebo |
| LY4178256 Part B: Multiple Ascending Dose (MAD) (Cohorts 1-3) | Experimental | LY4178256 or Placebo administered IV Receives: Drug: LY4178256; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration.
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Adverse Events module
Measured: Screening to Day 169
Part B: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration.
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Adverse Events module
Measured: Screening to Day 197
Secondary outcomes (2)
Part A: Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY4178256
To evaluate PK after a single dose of LY4178256
Measured: Predose up to Day 8
Part B: Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY4178256
To evaluate PK after multiple doses [LC14.1]of LY4178256
Measured: Predose up to Day 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start16 Jul 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 88 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
- NCT07698210
- Sponsor's protocol ID
- 27875
- Other IDs
- J7G-MC-OEAA
- Status last verified
- Aug 2026
- First submitted
- 8 Jul 2026
- Last updated
- 20 Aug 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4178256 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07698210
- Acronym / sponsor ID
- 27875
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 13 Jul 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 evaluate how well LY4178256 is tolerated and what side effects may occur in healthy participants. Blood tests will be performed to check how much LY4178256 gets into the bloodstream and how long it takes the body to eliminate it. For each participant, the study will last about 7 months and will include either 7 or 12 visits depending on the assigned treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY4178256 Part A: Single-Ascending Dose (SAD) (Cohorts 1-6b) | Experimental | Drug: LY4178256, Drug: PlaceboLY4178256 or Placebo administered Intravenously (IV) |
| LY4178256 Part B: Multiple Ascending Dose (MAD) (Cohorts 1-3) | Experimental | Drug: LY4178256, Drug: PlaceboLY4178256 or Placebo administered IV |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Are overtly healthy as determined by medical evaluation including medical history, physical examination, and other screening procedures.
- Have a body mass index within the range of 19.0 to 32.0 kilograms per square meter (kg/m²)
- Individuals assigned male at birth willing to practice effective contraception throughout the study and individuals assigned female at birth not of childbearing potential may participate in this trial.
Key exclusion criteria (8 listed)
- Have significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the Investigational Medicinal Product (IMP); or of interfering with the interpretation of data.
- Have abnormal blood pressure
- Have a 12-lead electrocardiogram (ECG) abnormality at screening that, in the opinion of the investigator, increases the risks associated with participating in the study, have a mean QT interval corrected using Fridericia's formula (QTcF) of greater than 450 milliseconds (>450 msec) for males, or >470 msec for females.
- Regularly use known drugs of abuse or with positive drug results (within the past 3 months).
- Have a positive ethanol breath/urine test result or positive urine drugs of abuse screen at screening or check-in.
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 |
|---|---|---|
| LY4178256Administered intravenously (IV) | Drug | LY4178256 Part A: Single-Ascending Dose (SAD) (Cohorts 1-6b), LY4178256 Part B: Multiple Ascending Dose (MAD) (Cohorts 1-3) |
| PlaceboAdministered IV | Drug | LY4178256 Part A: Single-Ascending Dose (SAD) (Cohorts 1-6b), LY4178256 Part B: Multiple Ascending Dose (MAD) (Cohorts 1-3) |
Primary outcome
Part A: 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: Screening to Day 169
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Adverse Events module
Part B: 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: Screening to Day 197
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Adverse Events module
2 secondary outcomes
Part A: Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY4178256
Time frame: Predose up to Day 8
Part B: Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY4178256
Time frame: Predose up to Day 64
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 20 Aug 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY4178256 in people with Healthy Volunteers, run by Eli Lilly and Company at 2 sites in United States.
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 3 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 20 Aug 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. 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?
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?
Part A: 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: Screening to Day 169). 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 20 Aug 2026.