RecruitingPhase 1NCT07152002

A Study of LY4064912 in Healthy Participants and With Overweight or Obesity

A Phase 1, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY4064912 in Healthy Participants and Participants With Overweight or Obesity


Sponsor

Eli Lilly and Company

Enrollment

144 participants

Start Date

Aug 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate how well LY4064912 is tolerated and what side effects may occur in healthy participants and participants with overweight and obesity - global. The study drug will be administered either subcutaneously (SC) (under the skin) or infusion intravenously (IV) (into a vein in the arm). Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria8

  • Age is 21-65 years old at Singapore Sites
  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
  • Part A: Body Mass Index (BMI) within the range greater than or equal to 21 and less than 30 kilogram per square meter (kg/m²)
  • Part B: a BMI greater than or equal to 27 and less than 45 kg/m²
  • Part C: a BMI greater than or equal to 21 and less than 35 kg/m²
  • Parts A and C: Participants must weigh 60 kilograms (kg) or more at screening
  • Have had a less than 5% change in body weight for 3 months before screening
  • Safety laboratory tests are within normal reference range

Exclusion Criteria3

  • Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
  • Have history of diabetes (except gestational diabetes) or current diagnosis of diabetes (any form), or have HbA1c greater than or equal to 6.5% (48 millimole per mole (mmol/mol)) at screening
  • Are individuals of childbearing potential (IOCBP).

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGLY4064912

Administered SC

DRUGLY4064912

Administered IV

DRUGPlacebo

Administered SC

DRUGPlacebo

Administered IV


Locations(3)

Collaborative Neuroscience Network - CNS

Los Alamitos, California, United States

ICON Early Phase Services

San Antonio, Texas, United States

Lilly Centre for Clinical Pharmacology

Singapore, Singapore

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07152002


Related Trials