ObesityPhase 1NCT07881887
A Study of LY4167586 in Participants With Obesity or Overweight With or Without Type 2 Diabetes
A Phase 1 study testing LY4167586 in people with Obesity and Overweight, run by Eli Lilly and Company at 12 sites in 2 countries.
Trial summary
The main purpose of this study is to look at how safe and well-tolerated LY4167586 is in participants with obesity or overweight with or without Type 2 Diabetes. 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Overweight, Diabetes Mellitus, Type 2
- 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
- 617 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Oct 2026to Mar 2029
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be 21 in Singapore.
- Have had a self-reported stable weight for 3 months prior to screening (less than approximately 5 percent (%) body weight change.
- Part A, B, D, and E
- Have a body mass index (BMI) of greater than or equal to 30 kilograms per square meter (kg/m²) or 27 to less than 30 kg/m² and previously diagnosed with at least one of the following weight-related comorbidities:
- hypertension
- dyslipidemia
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- obstructive sleep apnea, or
- prediabetes.
- Part C
- Have a BMI ≥25.0 kg/m²
- Have a diagnosis of Type 2 Diabetes (T2D) for at least 6 months.
- T2D controlled with diet and exercise alone or are on a stable dose of metformin alone, or in combination with a sodium-glucose co-transporter-2 inhibitor (SGLT-2i), for at least 3 months.
- Have a hemoglobin (HbA1c) value of ≥6.5 % and ≤10.0%.
- Part D
- To qualify as Chinese for this study, the participant must be at a minimum third-generation Chinese, defined as having all 4 of the participants' biological grandparents being of exclusive Chinese descent and born in China.
- Part E
- To qualify as Japanese for this study, the participant must be at a minimum third-generation Japanese, defined as having all 4 of the participants' biological grandparents being of exclusive Japanese descent and born in Japan.
Who cannot join
- Have a significant history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine (except for T2D in Part C), 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.
Trial locations and contacts
12 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
12 sites in 2 countries
United States11 sites
CenExel ACT
Anaheim, California, 92801
Amina Haggag
Ohio Clinical Trials
Columbus, Ohio, 43212
Angela Eakin
Fortrea Clinical Research Unit
Dallas, Texas, 75247
866-429-3700
Archie Bowie
Fortrea Clinical Research Unit
Daytona Beach, Florida, 32117
866-429-3700
Chiamaka Iheme
CenExel iResearch, LLC
Decatur, Georgia, 30030
Kimball Johnson
Collaborative Neuroscience Network - CNS
Los Alamitos, California, 90720
Steven Reynolds
CenExel-HRI
Marlton, New Jersey, 08053
Kyle Coupe
Advanced Pharma CR, LLC
Miami, Florida, 33417
Simon Abelson
Worldwide Clinical Trials, Inc.
San Antonio, Texas, 78217
Alan Hand
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Bonnie Kimmel
Clinical Site Partners, LLC DBA CSP Orlando
Winter Park, Florida, 32789
ROBERT MEYER
Singapore1 site
Lilly Centre for Clinical Pharmacology
Singapore, 138623
64139811
Jennifer Boon Wee
About this study
Official title: A Phase 1, Randomized, Participant- and Investigator-Blinded, Placebo-Controlled, Parallel-Design Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Dose Regimens of LY4167586 in Participants With Obesity or Overweight With or Without Type 2 Diabetes
The main purpose of this study is to look at how safe and well-tolerated LY4167586 is in participants with obesity or overweight with or without Type 2 Diabetes. 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 between approximately 53 to 89 weeks. For each participant (excluding those in Part B), the study will include between 5 and 7 stays in the Clinical Research Unit (CRU), each stay lasting between approximately 8 and 10 nights.
- Conditions
- Obesity, Overweight, Diabetes Mellitus, Type 2
- Being tested
- LY4167586, Placebo
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus, Type 2
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
| Study group | Role | What they receive |
|---|---|---|
| Part A: LY4167586 | Experimental | LY4167586 administered subcutaneously (SC) Receives: Drug: LY4167586 |
| Part B LY4167586 | Experimental | LY4167586 administered SC Receives: Drug: LY4167586 |
| Part C LY4167586 | Experimental | LY4167586 administered SC Receives: Drug: LY4167586 |
| Part D LY4167586 | Experimental | LY4167586 administered SC Receives: Drug: LY4167586 |
| Part E LY4167586 | Experimental | LY4167586 administered SC Receives: Drug: LY4167586 |
| Placebo (Part A-E) | Placebo comparator | Placebo 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 Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Measured: Baseline through Study Completion (Estimated as Week 89)
Secondary outcomes (5)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY4167586
Measured: Baseline up to Week 89
PK: Area Under the Concentration Time Curve (AUC) of LY4167586
Measured: Baseline up to Week 89
Body Weight Observed Value
Measured: Baseline up to Week 89
Change from Baseline in Body Weight
Measured: Baseline up to Week 89
Percent Change from Baseline in Body Weight
Measured: Baseline up to Week 89
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 617 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
- NCT07881887
- Sponsor's protocol ID
- 27671
- Other IDs
- J6L-MC-YIAB
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No