Actively Recruiting
A Phase 1, Randomized, Placebo-Controlled, Dose-Escalation Study of LY4064912 Given Subcutaneously or Intravenously in Healthy Participants and Those With Overweight or Obesity
Led by Eli Lilly and Company · Updated on 2026-04-20
144
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying LY4064912 to understand how well it is tolerated and what side effects it may cause in healthy people and those who are overweight or obese. This Phase 1 trial compares different ways of giving the drug, either under the skin (subcutaneously) or through an intravenous infusion, to see how the body processes it and how it affects participants. The study aims to gather initial safety and drug behavior data in these groups. Participants will receive LY4064912 or a placebo through subcutaneous injections or intravenous infusions in several groups. The trial includes single and multiple doses with escalating amounts to evaluate safety and tolerability. Different parts of the study focus on participants with various body mass index ranges, and some groups receive placebo treatments to compare results. During the study, participants will have regular blood tests to monitor how LY4064912 is processed by the body and to check its effects. Researchers will track serious side effects related to the drug for up to 27 weeks and measure changes in body weight, kidney function, and drug levels in the blood. The total participation time and safety monitoring will ensure thorough evaluation of the drug's impact over time.
CONDITIONS
Brief Title
A Study of LY4064912 in Healthy Participants and With Overweight or Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age is 21 to 65 years old at Singapore sites
- Participants must be overtly healthy based on medical history, physical exam, lab tests, and cardiac monitoring
- Part A: Body Mass Index (BMI) between 21 and less than 30 kg/m²
- Part B: BMI between 27 and less than 45 kg/m²
- Part C: BMI between 21 and less than 35 kg/m²
- Parts A and C: Participants must weigh 60 kg or more at screening
- Less than 5% change in body weight for 3 months before screening
- Safety laboratory tests within normal reference range
You will not qualify if you...
- History or presence of serious cardiovascular, respiratory, liver, kidney, gastrointestinal, endocrine, blood, or neurological disorders affecting drug absorption, metabolism, or elimination
- History of diabetes (except gestational diabetes) or current diabetes diagnosis
- HbA1c of 6.5% or higher at screening
- Individuals of childbearing potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants undergo initial assessments before receiving the study drug or placebo.
1 visit (in-person)
Duration - Up to 78 days
Participants receive LY4064912 or placebo administered subcutaneously or intravenously according to their assigned cohort.
Multiple visits during dosing and assessments
Duration - Up to approximately 27 weeks
Participants are monitored for safety and effects of the study drug after treatment ends.
Several follow-up visits (in-person)
Trial Site Locations
Total: 3 locations
1
Collaborative Neuroscience Network - CNS
Los Alamitos, California, United States, 90720
Actively Recruiting
2
ICON Early Phase Services
San Antonio, Texas, United States, 78209
Actively Recruiting
3
Lilly Centre for Clinical Pharmacology
Singapore, Singapore, 138623
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
7
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here