LY4064912 for healthy adults and people 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
PHASE1 · Eli Lilly and Company · NCT07152002
This study will test LY4064912 given by injection under the skin or by IV in healthy adults and in adults with overweight or obesity to see how safe it is and how the body handles the drug.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company (industry) |
| Locations | 3 sites (Los Alamitos, California and 2 other locations) |
| Trial ID | NCT07152002 on ClinicalTrials.gov |
What this trial studies
This Phase 1, interventional study enrolls healthy participants and adults with overweight or obesity across BMI-defined cohorts to characterize safety and how the drug is processed. Participants will receive LY4064912 or placebo administered subcutaneously or by intravenous infusion, with clinical monitoring and blood sampling. The protocol includes strict eligibility, weight-stability requirements, and routine laboratory and cardiac monitoring to detect adverse effects. Results will inform dosing, tolerability, and pharmacokinetics for later-stage research.
Who should consider this trial
Good fit: Adults who meet the protocol age and BMI windows (for example, Singapore sites enroll ages 21–65; cohort BMI ranges include 21–<30, 21–<35, and 27–<45 kg/m²), weigh ≥60 kg when required, have had stable weight for 3 months, and have normal safety laboratory results are ideal candidates.
Not a fit: People with significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disorders that affect drug absorption, metabolism, or safety, as well as those outside the BMI or lab criteria, are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, LY4064912 could become a new injectable option to explore for managing physiology related to overweight and obesity and guide further development.
How similar studies have performed: Other injectable obesity medications, such as GLP‑1 receptor agonists, have shown meaningful weight-loss effects in prior trials, but LY4064912 is a novel investigational agent that has not yet been proven effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Los Alamitos, California and 2 other locations
- Collaborative Neuroscience Network - CNS — Los Alamitos, California, United States (RECRUITING)
- ICON Early Phase Services — San Antonio, Texas, United States (RECRUITING)
- Lilly Centre for Clinical Pharmacology — Singapore, Singapore (RECRUITING)
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Overweight or Obesity, Healthy