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Not yet recruitingNCT07881887Updated Oct 20, 2026

A Study of LY4167586 in Participants With Obesity or Overweight With or Without Type 2 Diabetes

A Phase 1 interventional study of LY4167586 and Placebo in Obesity, Overweight and Diabetes Mellitus, Type 2, sponsored by Eli Lilly and Company. Not yet recruiting at 12 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Treatment

Updated Oct 20, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
617
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Obesity
  • Overweight
  • Diabetes Mellitus, Type 2
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's planned enrollment of 617 is above the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.

Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
    • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
617 participants (estimated)

Study arms

  • Experimental
    Part A: LY4167586

    LY4167586 administered subcutaneously (SC)

    Drug: LY4167586

  • Experimental
    Part B LY4167586

    LY4167586 administered SC

    Drug: LY4167586

  • Experimental
    Part C LY4167586

    LY4167586 administered SC

    Drug: LY4167586

  • Experimental
    Part D LY4167586

    LY4167586 administered SC

    Drug: LY4167586

  • Experimental
    Part E LY4167586

    LY4167586 administered SC

    Drug: LY4167586

  • Placebo comparator
    Placebo (Part A-E)

    Placebo administered SC

    Drug: Placebo

Interventions

  • DrugLY4167586

    administered SC

  • DrugPlacebo

    administered SC

06

What researchers measure

Primary outcomes

  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Time frame: Baseline through Study Completion (Estimated as Week 89)

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY4167586

    Time frame: Baseline up to Week 89

  2. PK: Area Under the Concentration Time Curve (AUC) of LY4167586

    Time frame: Baseline up to Week 89

  3. Body Weight Observed Value

    Time frame: Baseline up to Week 89

  4. Change from Baseline in Body Weight

    Time frame: Baseline up to Week 89

  5. Percent Change from Baseline in Body Weight

    Time frame: Baseline up to Week 89

07

Study locations

12 sites
  • CenExel ACT
    Anaheim, California 92801, United States
    • Amina Haggag · Principal investigator
  • Collaborative Neuroscience Network - CNS
    Los Alamitos, California 90720, United States
    • Steven Reynolds · Principal investigator
  • Diablo Clinical Research, Inc.
    Walnut Creek, California 94598, United States
    • Bonnie Kimmel · Principal investigator
  • Fortrea Clinical Research Unit
    Daytona Beach, Florida 32117, United States
    • · Contact · 866-429-3700
    • Chiamaka Iheme · Principal investigator
  • Advanced Pharma CR, LLC
    Miami, Florida 33417, United States
    • Simon Abelson · Principal investigator
  • Clinical Site Partners, LLC DBA CSP Orlando
    Winter Park, Florida 32789, United States
    • ROBERT MEYER · Principal investigator
  • CenExel iResearch, LLC
    Decatur, Georgia 30030, United States
    • Kimball Johnson · Principal investigator
  • CenExel-HRI
    Marlton, New Jersey 08053, United States
    • Kyle Coupe · Principal investigator
  • Ohio Clinical Trials
    Columbus, Ohio 43212, United States
    • Angela Eakin · Principal investigator
  • Fortrea Clinical Research Unit
    Dallas, Texas 75247, United States
    • · Contact · 866-429-3700
    • Archie Bowie · Principal investigator
  • Worldwide Clinical Trials, Inc.
    San Antonio, Texas 78217, United States
    • Alan Hand · Principal investigator
  • Lilly Centre for Clinical Pharmacology
    Singapore, 138623, Singapore
    • · Contact · 64139811
    • Jennifer Boon Wee · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07881887
Responsible party
Sponsor
First posted
Oct 20, 2026
Start date
Oct 2026 (estimated)
Primary completion
Mar 2029 (estimated)
Completion
Mar 2029 (estimated)
Last update
Oct 20, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
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

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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