OverweightPhase 1NCT07225556
A Study of LY4167586 in Participants With Obesity or Overweight Who Are Otherwise Healthy
A Phase 1 study testing LY4167586 in people with Overweight and Obesity, run by Eli Lilly and Company at 2 sites in 2 countries.
Trial summary
The purpose of this study is to look at how safe and well-tolerated LY4167586 is in participants with obesity or overweight who are otherwise healthy. Blood tests will be performed to check how much LY4167586 gets into the bloodstream and how long it takes the body to eliminate it following a single administration. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- LY4167586
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 18 Nov 2025to Dec 2026
- 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
- Participant must be 21 for Singapore site
- Have a body mass index (BMI) between 27.0 kilogram per square meter (kg/m²) and 35.0 kg/m², inclusive
- Have had a self-reported stable weight for 3 months prior to screening (less than approximately 5 percent [%] body weight change)
Who cannot join
- Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study drug, or of interfering with the interpretation of data.
- Is an individual of childbearing potential (IOCBP)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Fortrea Clinical Research Unit
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, Single Ascending Dose-Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4167586 in Participants With Obesity or Overweight Who Are Otherwise Healthy
The purpose of this study is to look at how safe and well-tolerated LY4167586 is in participants with obesity or overweight who are otherwise healthy. Blood tests will be performed to check how much LY4167586 gets into the bloodstream and how long it takes the body to eliminate it following a single administration. Participation in the study will last approximately 7 months.
- Conditions
- Overweight, Obesity
- Being tested
- LY4167586, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4167586Drug
Administered SC
PlaceboDrug
Administered SC
LY4167586Drug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| LY4167586 (Cohorts A1 to A6) | Experimental | LY4167586 administered subcutaneously (SC) Receives: Drug: LY4167586 |
| Placebo (Cohorts A1 to A6) | Placebo comparator | Placebo administered SC Receives: Drug: Placebo |
| LY4167586 (Cohort B) | Experimental | LY4167586 administered intravenously (IV) Receives: Drug: LY4167586 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Incidence of Serious Adverse Events (SAEs)
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline to study completion (up to 29 weeks)
Secondary outcomes (3)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax)
PK: Cmax of LY4167586
Measured: Predose on Day 1 through end of the Follow-up Period (Week 25)
PK: Time of Maximum Drug Concentration (tmax)
PK: tmax of LY4167586
Measured: Predose on Day 1 through end of the Follow-up Period (Week 25)
PK: Area Under the Concentration Versus Time Curve (AUC)
PK: AUC of LY4167586
Measured: Predose on Day 1 through end of the Follow-up Period (Week 25)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2025
- Study start18 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- 84 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
- NCT07225556
- Sponsor's protocol ID
- 27659
- Other IDs
- J6L-MC-YIAA
- Status last verified
- Jul 2026
- First submitted
- 20 Oct 2025
- Last updated
- 29 Jul 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled, Single Ascending Dose-Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4167586 in Participants With Obesity or Overweight Who Are Otherwise Healthy
- ClinicalTrials.gov ID
- NCT07225556
- Acronym / sponsor ID
- 27659
- Conditions
- Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Nov 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 look at how safe and well-tolerated LY4167586 is in participants with obesity or overweight who are otherwise healthy. Blood tests will be performed to check how much LY4167586 gets into the bloodstream and how long it takes the body to eliminate it following a single administration. Participation in the study will last approximately 7 months.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LY4167586 (Cohorts A1 to A6) | Experimental | Drug: LY4167586LY4167586 administered subcutaneously (SC) |
| Placebo (Cohorts A1 to A6) | Placebo comparator | Drug: PlaceboPlacebo administered SC |
| LY4167586 (Cohort B) | Experimental | Drug: LY4167586LY4167586 administered intravenously (IV) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant must be 21 for Singapore site
- Have a body mass index (BMI) between 27.0 kilogram per square meter (kg/m²) and 35.0 kg/m², inclusive
- Have had a self-reported stable weight for 3 months prior to screening (less than approximately 5 percent [%] body weight change)
Key exclusion criteria (2 listed)
- Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study drug, or of interfering with the interpretation of data.
- Is an individual of childbearing potential (IOCBP)
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 |
|---|---|---|
| LY4167586Administered SC | Drug | LY4167586 (Cohorts A1 to A6) |
| PlaceboAdministered SC | Drug | Placebo (Cohorts A1 to A6) |
| LY4167586Administered IV | Drug | LY4167586 (Cohort B) |
Primary outcome
Number and Incidence of Serious Adverse Events (SAEs)
Time frame: Baseline to study completion (up to 29 weeks)
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
3 secondary outcomes
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax)
Time frame: Predose on Day 1 through end of the Follow-up Period (Week 25)
PK: Time of Maximum Drug Concentration (tmax)
Time frame: Predose on Day 1 through end of the Follow-up Period (Week 25)
PK: Area Under the Concentration Versus Time Curve (AUC)
Time frame: Predose on Day 1 through end of the Follow-up Period (Week 25)
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 29 Jul 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
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 LY4167586 in people with Overweight and Obesity, 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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 29 Jul 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?
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?
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 and Incidence of Serious Adverse Events (SAEs) (time frame: Baseline to study completion (up to 29 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 29 Jul 2026.