LY4167586 for adults with overweight or obesity who are otherwise healthy
A Phase 1, Randomized, Placebo-Controlled, Single Ascending Dose-Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4167586 in Participants With Obesity or Overweight Who Are Otherwise Healthy
This trial will test a single dose of LY4167586 in otherwise healthy adults with overweight or obesity to see how safe it is and how the body absorbs and clears the drug.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 2 sites (Madison, Wisconsin and 1 other locations) |
| Trial ID | NCT07225556 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1, randomized interventional study that gives LY4167586 or placebo as a single administration and follows participants for about seven months. Blood samples will be collected to measure how much drug reaches the bloodstream and how long it takes to be eliminated (pharmacokinetics), along with monitoring for safety and tolerability. The study enrolls otherwise healthy adults with a BMI of 27.0–35.0 kg/m² and requires stable weight for the prior three months. Study visits are conducted at clinical pharmacology units in Madison, Wisconsin and at Lilly’s center in Singapore.
Who should consider this trial
Good fit: Otherwise healthy adults with a BMI between 27.0 and 35.0 kg/m² who have had stable weight and meet site age requirements (for example, 21+ at the Singapore site) and are not individuals of childbearing potential.
Not a fit: People with significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disorders, as well as individuals of childbearing potential, would likely be excluded and are unlikely to receive direct benefit from participation.
Why it matters
Potential benefit: If successful, the study could show that LY4167586 is safe and has predictable blood levels, supporting further testing as a possible treatment for overweight or obesity.
How similar studies have performed: Phase 1 safety and pharmacokinetic studies are a standard first step and have supported development of other obesity drugs, but LY4167586 itself is a novel investigational compound at this stage.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant must be 21 for Singapore site * Have a body mass index (BMI) between 27.0 kilogram per square meter (kg/m²) and 35.0 kg/m², inclusive * Have had a self-reported stable weight for 3 months prior to screening (less than approximately 5 percent \[%\] body weight change) Exclusion Criteria: * Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study drug, or of interfering with the interpretation of data. * Is an individual of childbearing potential (IOCBP)
Where this trial is running
Madison, Wisconsin and 1 other locations
- Fortrea Clinical Research Unit — Madison, Wisconsin, 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.