HealthyPhase 1NCT07767487
A Study of LY4226695 in Healthy Participants
A Phase 1 study testing LY4226695 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 LY4226695 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 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY4226695
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 27 Aug 2026to 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 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have a screening body mass index (BMI) in the range of 18.5 to 35 kilograms per square meter (kg/m²), inclusive, with no significant weight gain or loss in the past 3 months prior to screening.
- Individuals assigned male at birth must agree to adhere to contraception restrictions and individuals assigned female at birth must not be of childbearing potential.
- Part B Chinese participants:
- To qualify as a Chinese participant for the purpose of this study, all the participants' biological grandparents must be Chinese and born in China.
- Part C Japanese participants:
- To qualify as a Japanese participant for the purpose of this study, all the participants' biological grandparents must be Japanese and born in Japan.
Who cannot join
- Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders.
- Have known or ongoing psychiatric disorders.
- Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives (parents, siblings, or children).
- Have a history of fracture within 6 months prior to screening.
- Have a history of fainting.
- Regularly use known drugs of abuse or with positive drug results.
- Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation.
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
- Not yet recruiting
CenExel ACT
Anaheim, California, 92801
714-774-7777
Amina Haggag
Singapore1 site, 1 recruiting
- Recruiting
Lilly Centre for Clinical Pharmacology
Singapore, 138623
64139811
Jennifer Boon Wee
About this study
Official title: A Single-ascending and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY4226695 in Healthy Participants
The main purpose of this study is to assess how well LY4226695 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 in Parts A \& D, the study will last about 64 days and will include a stay in the Clinical Research Unit (CRU) lasting at most 7 days. For each participant in Parts B \& C, the study will last about 92 days and will include 5 stays in the CRU with each visit lasting at most 7 days.
- Conditions
- Healthy
- Being tested
- LY4226695, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4226695Drug
Administered SC
LY4226695Drug
Administered IV
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY4226695 Part A | Experimental | Participants will receive LY4226695 or placebo administered subcutaneously (SC) Receives: Drug: LY4226695; Drug: Placebo |
| LY4226695 Part B | Experimental | Participants will receive LY4226695 or placebo administered SC Receives: Drug: LY4226695; Drug: Placebo |
| LY4226695 Part C | Experimental | Participants will receive LY4226695 or placebo administered SC Receives: Drug: LY4226695; Drug: Placebo |
| LY4226695 Part D | Experimental | Participants will receive LY4226695 administered intravenously (IV) Receives: Drug: LY4226695 |
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: Baseline through Day 57
Secondary outcomes (2)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4226695
Measured: Baseline through Day 57
PK: Maximum Concentration (Cmax) of LY4226695
Measured: Baseline through Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start27 Aug 2026
- 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
- 148 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
- NCT07767487
- Sponsor's protocol ID
- 27918
- Other IDs
- J7R-MC-EMCA
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2026
- Last updated
- 22 Sep 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-ascending and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY4226695 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07767487
- Acronym / sponsor ID
- 27918
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Aug 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 LY4226695 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 in Parts A \& D, the study will last about 64 days and will include a stay in the Clinical Research Unit (CRU) lasting at most 7 days. For each participant in Parts B \& C, the study will last about 92 days and will include 5 stays in the CRU with each visit lasting at most 7 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 |
|---|---|---|
| LY4226695 Part A | Experimental | Drug: LY4226695, Drug: PlaceboParticipants will receive LY4226695 or placebo administered subcutaneously (SC) |
| LY4226695 Part B | Experimental | Drug: LY4226695, Drug: PlaceboParticipants will receive LY4226695 or placebo administered SC |
| LY4226695 Part C | Experimental | Drug: LY4226695, Drug: PlaceboParticipants will receive LY4226695 or placebo administered SC |
| LY4226695 Part D | Experimental | Drug: LY4226695Participants will receive LY4226695 administered intravenously (IV) |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have a screening body mass index (BMI) in the range of 18.5 to 35 kilograms per square meter (kg/m²), inclusive, with no significant weight gain or loss in the past 3 months prior to screening.
- Individuals assigned male at birth must agree to adhere to contraception restrictions and individuals assigned female at birth must not be of childbearing potential.
- Part B Chinese participants:
- Part C Japanese participants:
Key exclusion criteria (7 listed)
- Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders.
- Have known or ongoing psychiatric disorders.
- Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives (parents, siblings, or children).
- Have a history of fracture within 6 months prior to screening.
- Have a history of fainting.
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 |
|---|---|---|
| LY4226695Administered SC | Drug | LY4226695 Part A, LY4226695 Part B, LY4226695 Part C |
| LY4226695Administered IV | Drug | LY4226695 Part D |
| PlaceboAdministered SC | Drug | LY4226695 Part A, LY4226695 Part B, LY4226695 Part C |
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 through Day 57
2 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4226695
Time frame: Baseline through Day 57
PK: Maximum Concentration (Cmax) of LY4226695
Time frame: Baseline through Day 57
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 22 Sep 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 LY4226695 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 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 22 Sep 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. 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 through Day 57). 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 22 Sep 2026.