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Starting soon Phase 1

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

NCT07881887 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2026-10
Last updated
2026-10-20

Condition(s) studied

ObesityOverweightDiabetes Mellitus, Type 2

Investigational drug(s) / intervention(s)

LY4167586 →Placebo

LY4167586: administered SC

Placebo: administered SC

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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: * 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.

Primary outcome measure(s)

  • Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — Baseline through Study Completion (Estimated as Week 89)

Trial sites (12)

FacilityCityRegionStatus
CenExel ACT Anaheim California
Collaborative Neuroscience Network - CNS Los Alamitos California
Diablo Clinical Research, Inc. Walnut Creek California
Fortrea Clinical Research Unit Daytona Beach Florida
Advanced Pharma CR, LLC Miami Florida
Clinical Site Partners, LLC DBA CSP Orlando Winter Park Florida
CenExel iResearch, LLC Decatur Georgia
CenExel-HRI Marlton New Jersey
Ohio Clinical Trials Columbus Ohio
Fortrea Clinical Research Unit Dallas Texas
Worldwide Clinical Trials, Inc. San Antonio Texas
Lilly Centre for Clinical Pharmacology Singapore Singapore
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07881887 on ClinicalTrials.gov ↗ ← All trials in the USA