A Study of LY4167586 in Participants With Obesity or Overweight Who Are Otherwise Healthy

Not Applicable

Not yet recruiting

• Conditions: Overweight; Obesity
• Interventions: Drug: LY4167586; Drug: Placebo

• Registration Number: NCT07225556
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-10-20
• Status Verified: 2025-11
• Study Start: 2025-11-01
• Study First Submitted QC: 2025-11-05
• Last Update Submitted: 2025-11-05
• Study First Posted: 2025-11-06
• Last Update Posted: 2025-11-06
• Primary Completion: 2026-12
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• 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)

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY4167586 (Cohorts A1 to A6)	LY4167586	LY4167586 administered subcutaneously (SC)
LY4167586 (Cohorts A1 to A6) Placebo	Placebo	LY4167586 administered SC
LY4167586 (Cohort B)	LY4167586	LY4167586 administered intravenously (IV)

Primary Outcome Measures

Name	Time	Method
Number and Incidence of Serious Adverse Events (SAEs)	Baseline to study completion (up to 29 weeks)	A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax)	Predose on Day 1 through end of the Follow-up Period (Week 25)	PK: Cmax of LY4167586
PK: Time of Maximum Drug Concentration (tmax)	Predose on Day 1 through end of the Follow-up Period (Week 25)	PK: tmax of LY4167586
PK: Area Under the Concentration Versus Time Curve (AUC)	Predose on Day 1 through end of the Follow-up Period (Week 25)	PK: AUC of LY4167586

Trial Locations

Locations (2)

Fortrea Clinical Research Unit; 🇺🇸 Madison, Wisconsin, United States

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore