HealthyPhase 1NCT07030127
A Study of LY3985863 in Healthy Participants
A Phase 1 study testing LY3985863 in people with Healthy, run by Eli Lilly and Company at 1 site in China.
Trial summary
The purpose of this study is to evaluate how well LY3985863 is tolerated and what side effects may occur in healthy Chinese participants. The study drug will be administered subcutaneously (SC) (under the skin). 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?
- LY3985863
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2025to 24 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 native Chinese participants
- Are overtly healthy
- Have body weight of at least 50.0 kilogram (kg) for male or 45.0 kg for female and a body mass index of 20.0 to 30.0 kilogram per square meter (kg/m²), inclusive
- Have a stable body weight within 3 months
Who cannot join
- Have known allergies to any components of the LY3985863 formulation
- Have concomitant disease known to influence skeletal muscle protein
- Have current or a history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs, of constituting a risk when taking the study medication or completing study procedures, or of interfering with the interpretation of the data
- Have a 12-lead echocardiogram (ECG) abnormality
- Have used within 3 months or intend to use medications during the study that promote weight loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Participant- and Investigator-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Doses of LY3985863 in Healthy Chinese Participants
The purpose of this study is to evaluate how well LY3985863 is tolerated and what side effects may occur in healthy Chinese participants. The study drug will be administered subcutaneously (SC) (under the skin).
Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
- Conditions
- Healthy
- Being tested
- LY3985863, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3985863Drug
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY3985863 | Experimental | Administered subcutaneously (SC) Receives: Drug: LY3985863 |
| Placebo | Placebo comparator | 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 Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline to Study Completion (Up to 19 Weeks)
Secondary outcomes (2)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3985863
PK: Cmax of LY3985863
Measured: Predose on Day 1 up to Approximately Week 8 Post Dose
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3985863
PK: AUC of LY3985863
Measured: Predose on Day 1 up to Approximately Week 8 Post Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start11 Aug 2025
- Primary completion24 Feb 2026
- Study completion24 Feb 2026
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
- 24 participants (actual)
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
- NCT07030127
- Sponsor's protocol ID
- 27292
- Other IDs
- J4Z-MC-GIDH
- Status last verified
- Mar 2026
- First submitted
- 12 Jun 2025
- Last updated
- 11 Mar 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 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Participant- and Investigator-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Doses of LY3985863 in Healthy Chinese Participants
- ClinicalTrials.gov ID
- NCT07030127
- Acronym / sponsor ID
- 27292
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 24 Feb 2026 (actual)
- Study completion
- 24 Feb 2026 (actual)
- First posted
- 22 Jun 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 LY3985863 is tolerated and what side effects may occur in healthy Chinese participants. The study drug will be administered subcutaneously (SC) (under the skin).
Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY3985863 | Experimental | Drug: LY3985863Administered subcutaneously (SC) |
| Placebo | Placebo comparator | Drug: PlaceboAdministered SC |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are native Chinese participants
- Are overtly healthy
- Have body weight of at least 50.0 kilogram (kg) for male or 45.0 kg for female and a body mass index of 20.0 to 30.0 kilogram per square meter (kg/m²), inclusive
- Have a stable body weight within 3 months
Key exclusion criteria (5 listed)
- Have known allergies to any components of the LY3985863 formulation
- Have concomitant disease known to influence skeletal muscle protein
- Have current or a history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs, of constituting a risk when taking the study medication or completing study procedures, or of interfering with the interpretation of the data
- Have a 12-lead echocardiogram (ECG) abnormality
- Have used within 3 months or intend to use medications during the study that promote weight loss
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 |
|---|---|---|
| LY3985863Administered SC | Drug | LY3985863 |
| PlaceboAdministered SC | Drug | Placebo |
Primary outcome
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline to Study Completion (Up to 19 Weeks)
A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
2 secondary outcomes
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3985863
Time frame: Predose on Day 1 up to Approximately Week 8 Post Dose
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3985863
Time frame: Predose on Day 1 up to Approximately Week 8 Post Dose
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 11 Mar 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.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3985863 in people with Healthy, run by Eli Lilly and Company at 1 site in China.
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 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline to Study Completion (Up to 19 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 11 Mar 2026.