NCT07225556

Brief 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. Participation in the study will last approximately 7 months.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for phase_1

Timeline
7mo left

Started Nov 2025

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Nov 2025Dec 2026

First Submitted

Initial submission to the registry

October 20, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 6, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

November 18, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

October 20, 2025

Last Update Submit

March 6, 2026

Conditions

OverweightObesity

Outcome Measures

Primary Outcomes (1)

  • Number and Incidence of Serious Adverse Events (SAEs)

    A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module

    Baseline to study completion (up to 29 weeks)

Secondary Outcomes (3)

  • Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax)

    Predose on Day 1 through end of the Follow-up Period (Week 25)

  • PK: Time of Maximum Drug Concentration (tmax)

    Predose on Day 1 through end of the Follow-up Period (Week 25)

  • PK: Area Under the Concentration Versus Time Curve (AUC)

    Predose on Day 1 through end of the Follow-up Period (Week 25)

Study Arms (3)

LY4167586 (Cohorts A1 to A6)

EXPERIMENTAL

LY4167586 administered subcutaneously (SC)

Drug: LY4167586

LY4167586 (Cohorts A1 to A6) Placebo

PLACEBO COMPARATOR

LY4167586 administered SC

Drug: Placebo

LY4167586 (Cohort B)

EXPERIMENTAL

LY4167586 administered intravenously (IV)

Drug: LY4167586

Interventions

PlaceboDRUG

Administered SC

LY4167586 (Cohorts A1 to A6) Placebo
LY4167586DRUG

Administered SC

LY4167586 (Cohorts A1 to A6)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fortrea Clinical Research Unit

Madison, Wisconsin, 53704, United States

RECRUITING

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

RECRUITING

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2025

First Posted

November 6, 2025

Study Start

November 18, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)SG(1)