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
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