HealthyPhase 1NCT07090785
A Study of LY4088044 in Healthy Participants
A Phase 1 study testing LY4088044 in people with Healthy, run by Eli Lilly and Company at 6 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate how well LY4088044 is tolerated and what side effects may occur in healthy participants. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). 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?
- LY4088044
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 24 Jul 2025to Jul 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 including medical history, physical examination, laboratory tests, vital signs, and cardiac monitoring
- Have a body mass index (BMI) within the range 18.5 to 30 kilogram per square meter (kg/m²)
Who cannot join
- Are individuals assigned female at birth (AFAB) who are pregnant and/or lactating
- Regularly use known drugs of abuse or show positive findings on urinary drug screening that are not consistent with their medication history
- Participants with hemoglobin outside of the local laboratory normal range for age and gender, or evidence of iron deficiency, or hemoglobinopathy
- Participants with estimated glomerular filtration rate (GFR) less than 90 milliliter per minute per 1.73 square meter (mL/min/1.73 m²)
- Have a 12-lead electrocardiogram (ECG) abnormality
- Smoke more than 10 cigarettes per day or the equivalent including electronic cigarettes AND are unable to abide by investigative site smoking restrictions
- Have an average weekly alcohol intake that exceeds 21 units per week (males less than or equal to 65 years old) and 14 units per week (females and males over 65-year-old, if applicable) and are unwilling to abide by the restrictions
Trial locations and contacts
6 sites in 3 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
6 sites in 3 countries
United States4 sites, 2 recruiting
- Suspended
ICON
Lenexa, Kansas, 66219
- Active, not recruiting
Collaborative Neuroscience Network - CNS
Los Alamitos, California, 90720
- Recruiting
ICON
Salt Lake City, Utah, 84124
801-269-8200
Ahad Sabet
- Recruiting
ICON Early Phase Services
San Antonio, Texas, 78232
210-283-4156
Chinonye Ogbonnaya-Odor
New Zealand1 site, 1 recruiting
- Not yet recruiting
New Zealand Clinical Research Christchurch
Christchurch, 8011
Chris Wynne
Singapore1 site, 1 recruiting
- Recruiting
Lilly Centre for Clinical Pharmacology
Singapore, 138623
+65 6413 9811
Jeffer Hann Wei Pang
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4088044 in Healthy Participants.
The purpose of this study is to evaluate how well LY4088044 is tolerated and what side effects may occur in healthy participants. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4088044 gets into the bloodstream and how long it takes the body to eliminate it.
The study will last up to approximately 92 weeks for Parts A, B, and C, excluding screening.
- Conditions
- Healthy
- Being tested
- LY4088044, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4088044Drug
Administered IV
LY4088044Drug
Administered SC
PlaceboDrug
Administered IV
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY4088044 (Part A) | Experimental | Single-ascending dose (SAD) of LY4088044 administered intravenously (IV) Receives: Drug: LY4088044 |
| Placebo (Part A) | Placebo comparator | Administered IV Receives: Drug: Placebo |
| LY4088044 (Part B) | Experimental | SAD of LY4088044 administered subcutaneously (SC) Receives: Drug: LY4088044 |
| Placebo (Part B) | Placebo comparator | Administered SC Receives: Drug: Placebo |
| LY4088044 (Part C) | Experimental | Multiple-ascending doses (MAD) of LY4088044 administered IV Receives: Drug: LY4088044 |
| Placebo (Part C) | Placebo comparator | Administered IV 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
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline up to Approximately Day 190
Secondary outcomes (3)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4088044
PK: Cmax of LY4088044
Measured: Baseline up to Approximately Day 190
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4088044
PK: AUC of LY4088044
Measured: Baseline up to Approximately Day 190
Pharmacodynamics (PD): Protein Levels in Skin Samples
PD: Percent Decrease in Protein Levels
Measured: Baseline up to Approximately Day 190
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start24 Jul 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 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
- 104 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
- NCT07090785
- Sponsor's protocol ID
- 27275
- Other IDs
- J5S-MC-CEAA
- Status last verified
- Oct 2026
- First submitted
- 9 Jul 2025
- Last updated
- 7 Oct 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4088044 in Healthy Participants.
- ClinicalTrials.gov ID
- NCT07090785
- Acronym / sponsor ID
- 27275
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 29 Jul 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 purpose of this study is to evaluate how well LY4088044 is tolerated and what side effects may occur in healthy participants. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4088044 gets into the bloodstream and how long it takes the body to eliminate it.
The study will last up to approximately 92 weeks for Parts A, B, and C, excluding screening.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| LY4088044 (Part A) | Experimental | Drug: LY4088044Single-ascending dose (SAD) of LY4088044 administered intravenously (IV) |
| Placebo (Part A) | Placebo comparator | Drug: PlaceboAdministered IV |
| LY4088044 (Part B) | Experimental | Drug: LY4088044SAD of LY4088044 administered subcutaneously (SC) |
| Placebo (Part B) | Placebo comparator | Drug: PlaceboAdministered SC |
| LY4088044 (Part C) | Experimental | Drug: LY4088044Multiple-ascending doses (MAD) of LY4088044 administered IV |
| Placebo (Part C) | Placebo comparator | Drug: PlaceboAdministered IV |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and cardiac monitoring
- Have a body mass index (BMI) within the range 18.5 to 30 kilogram per square meter (kg/m²)
Key exclusion criteria (7 listed)
- Are individuals assigned female at birth (AFAB) who are pregnant and/or lactating
- Regularly use known drugs of abuse or show positive findings on urinary drug screening that are not consistent with their medication history
- Participants with hemoglobin outside of the local laboratory normal range for age and gender, or evidence of iron deficiency, or hemoglobinopathy
- Participants with estimated glomerular filtration rate (GFR) less than 90 milliliter per minute per 1.73 square meter (mL/min/1.73 m²)
- Have a 12-lead electrocardiogram (ECG) abnormality
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 |
|---|---|---|
| LY4088044Administered IV | Drug | LY4088044 (Part A), LY4088044 (Part C) |
| LY4088044Administered SC | Drug | LY4088044 (Part B) |
| PlaceboAdministered IV | Drug | Placebo (Part A), Placebo (Part C) |
| PlaceboAdministered SC | Drug | Placebo (Part B) |
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: Baseline up to Approximately Day 190
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
3 secondary outcomes
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4088044
Time frame: Baseline up to Approximately Day 190
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4088044
Time frame: Baseline up to Approximately Day 190
Pharmacodynamics (PD): Protein Levels in Skin Samples
Time frame: Baseline up to Approximately Day 190
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 7 Oct 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
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY4088044 in people with Healthy, run by Eli Lilly and Company at 6 sites in 3 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 2 inclusion and 7 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 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, New Zealand, 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: Baseline up to Approximately Day 190). 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 7 Oct 2026.