Healthy ParticipantsPhase 1NCT06709820
A Study of LY4060874 in Healthy Participants
A Phase 1 study testing LY4060874 in people with Healthy Participants, run by Eli Lilly and Company at 2 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate safety and tolerability of LY4060874 in healthy participants. Study participation may last up to 22 weeks and up to approximately 18 study visits. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- LY4060874
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 2 Dec 2024to 20 Feb 2026
- 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 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 and physical examination.
- Have a body mass index in the range of 20 to 29.9 kilogram per meter squared (kg/m²), inclusive, at screening.
- To qualify as Chinese for this study, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China.
- To qualify as a participant of first-generation Japanese origin, the participant, the participant's biological parents, and all the participants' biological grandparents must be of exclusive Japanese descent and born in Japan.
Who cannot join
- Have a history of or have been diagnosed with Type 1 or Type 2 diabetes mellitus.
- Have hemoglobin A1c (HbA1c) > 6.4% or 46 millimoles/mole (mmol/mol) at screening.
- Have taken approved, including over the counter (OTC) or prescribed, medication or investigational medication for weight loss, including GLP-1 receptor agonists, within the previous 3 months of study screening.
- Have had surgical treatment for obesity.
- Are actively participating in a weight loss program or intend to initiate an intensive diet and/or exercise program during the study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY4060874 in Healthy Participants
The purpose of this study is to evaluate safety and tolerability of LY4060874 in healthy participants.
Study participation may last up to 22 weeks and up to approximately 18 study visits.
- Conditions
- Healthy Participants
- Being tested
- LY4060874, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4060874Drug
Administered SC
LY4060874Drug
Administered IV
PlaceboDrug
Administered SC
PlaceboDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| LY4060874 (Part A Subcutaneous) | Experimental | Single ascending dose of LY4060874 administered subcutaneously (SC). Receives: Drug: LY4060874 |
| LY4060874 (Part A Intravenous) | Experimental | Single ascending dose of LY4060874 administered intravenously (IV). Receives: Drug: LY4060874 |
| LY4060874 (Part B) | Experimental | Multiple ascending doses of LY4060874 administered SC. Receives: Drug: LY4060874 |
| LY4060874 (Part B Chinese) | Experimental | Multiple ascending doses of LY4060874 administered SC in Chinese participants. Receives: Drug: LY4060874 |
| LY4060874 (Part C Japanese) | Experimental | Multiple ascending doses of LY4060874 administered SC in Japanese participants. Receives: Drug: LY4060874 |
| Placebo (SC) | Placebo comparator | Placebo administered SC in Part A, B, and C. Receives: Drug: Placebo |
| Placebo (IV) | Placebo comparator | Placebo administered IV in Part A. 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 Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Number of participants with one or more TEAEs and SAEs.
Measured: Baseline up to 22 Weeks
Secondary outcomes (2)
Pharmacokinetics (PK): Area Under the Concentration Versus Time (AUC) of LY4060874
PK: Area Under the Concentration Versus Time (AUC) of LY4060874
Measured: PK: Part A: Baseline up to 13 weeks; Part B and C: Baseline up to 18 weeks
PK: Maximum Observed Concentration of LY4060874
PK: Cmax of LY4060874
Measured: PK: Part A: Baseline up to 13 weeks; Part B and C: Baseline up to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start2 Dec 2024
- Primary completion20 Feb 2026
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 1-877-CTLILLY (1-877-285-4559) or 3176154559 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
- NCT06709820
- Sponsor's protocol ID
- 27300
- Other IDs
- J5X-MC-YJAA
- Status last verified
- Apr 2026
- First submitted
- 26 Nov 2024
- Last updated
- 3 Apr 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 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY4060874 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06709820
- Acronym / sponsor ID
- 27300
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 29 Nov 2024 (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 safety and tolerability of LY4060874 in healthy participants.
Study participation may last up to 22 weeks and up to approximately 18 study visits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| LY4060874 (Part A Subcutaneous) | Experimental | Drug: LY4060874Single ascending dose of LY4060874 administered subcutaneously (SC). |
| LY4060874 (Part A Intravenous) | Experimental | Drug: LY4060874Single ascending dose of LY4060874 administered intravenously (IV). |
| LY4060874 (Part B) | Experimental | Drug: LY4060874Multiple ascending doses of LY4060874 administered SC. |
| LY4060874 (Part B Chinese) | Experimental | Drug: LY4060874Multiple ascending doses of LY4060874 administered SC in Chinese participants. |
| LY4060874 (Part C Japanese) | Experimental | Drug: LY4060874Multiple ascending doses of LY4060874 administered SC in Japanese participants. |
| Placebo (SC) | Placebo comparator | Drug: PlaceboPlacebo administered SC in Part A, B, and C. |
| Placebo (IV) | Placebo comparator | Drug: PlaceboPlacebo administered IV in Part A. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are overtly healthy as determined by medical evaluation, including medical history and physical examination.
- Have a body mass index in the range of 20 to 29.9 kilogram per meter squared (kg/m²), inclusive, at screening.
- To qualify as Chinese for this study, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China.
- To qualify as a participant of first-generation Japanese origin, the participant, the participant's biological parents, and all the participants' biological grandparents must be of exclusive Japanese descent and born in Japan.
Key exclusion criteria (5 listed)
- Have a history of or have been diagnosed with Type 1 or Type 2 diabetes mellitus.
- Have hemoglobin A1c (HbA1c) > 6.4% or 46 millimoles/mole (mmol/mol) at screening.
- Have taken approved, including over the counter (OTC) or prescribed, medication or investigational medication for weight loss, including GLP-1 receptor agonists, within the previous 3 months of study screening.
- Have had surgical treatment for obesity.
- Are actively participating in a weight loss program or intend to initiate an intensive diet and/or exercise program during the study.
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 |
|---|---|---|
| LY4060874Administered SC | Drug | LY4060874 (Part A Subcutaneous), LY4060874 (Part B Chinese), LY4060874 (Part B), LY4060874 (Part C Japanese) |
| LY4060874Administered IV | Drug | LY4060874 (Part A Intravenous) |
| PlaceboAdministered SC | Drug | Placebo (SC) |
| PlaceboAdministered IV | Drug | Placebo (IV) |
Primary outcome
Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to 22 Weeks
Number of participants with one or more TEAEs and SAEs.
2 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time (AUC) of LY4060874
Time frame: PK: Part A: Baseline up to 13 weeks; Part B and C: Baseline up to 18 weeks
PK: Maximum Observed Concentration of LY4060874
Time frame: PK: Part A: Baseline up to 13 weeks; Part B and C: Baseline up to 18 weeks
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 3 Apr 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.
1-877-CTLILLY (1-877-285-4559) or 3176154559 Mon - Fri 9 AM - 5 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 LY4060874 in people with Healthy Participants, 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 4 inclusion and 5 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 3 Apr 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?
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?
Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to 22 Weeks). 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 3 Apr 2026.