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

Purpose

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.

Conditions

  • Overweight or Obesity
  • Healthy

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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 Criteria

  • 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).

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A: LY4064912 (Cohorts 1-6) 		LY4064912 administered subcutaneously (SC)
  • Drug: LY4064912
    Administered SC
Experimental
Part A: LY4064912 (Cohort 4b) 		LY4064912 administered intravenously (IV)
  • Drug: LY4064912
    Administered IV
Placebo Comparator
Part A: Placebo 		Placebo administered SC and IV
  • Drug: Placebo
    Administered SC
  • Drug: Placebo
    Administered IV
Experimental
Part B: LY4064912 (Cohorts 7-10) 		LY4064912 administered SC
  • Drug: LY4064912
    Administered SC
Placebo Comparator
Part B: Placebo 		Placebo administered SC
  • Drug: Placebo
    Administered SC
Experimental
Part C: LY4064912 (Cohort 11) 		LY4064912 administered SC
  • Drug: LY4064912
    Administered SC
Experimental
Part C: Placebo 		Placebo administered SC
  • Drug: Placebo
    Administered SC

Recruiting Locations

ICON Early Phase Services
San Antonio 4726206, Texas 4736286 78209
Contact:
210-225-5437

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com