Healthy, Overweight or Obesity
Conditions
Brief 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.
Interventions
DRUGLY4064912
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Postdose to Approximately Week 27 | A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4064912 | Predose Up to Day 78 | PK: AUC of LY4064912 |
| PK: Maximum Concentration (Cmax) of LY4064912 | Predose Up to Day 78 | PK: Cmax of LY4064912 |
| Change from Baseline in Body Weight | Baseline to Approximately Week 27 | Change from Baseline in Body Weight |
| Effects of LY4064912 on Renal Hemodynamics and Renal Function | Baseline Up to Day 31 | Glomerular Filtration Rate (GFR) |
Countries
Singapore, United States
Contacts
STUDY_DIRECTORCall 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
Outcome results
None listed