Evaluating LY4060874 in healthy individuals
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY4060874 in Healthy Participants
This study is testing the safety of a new drug called LY4060874 in healthy people to see how well they tolerate it compared to a placebo.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 2 sites (Dallas, Texas and 1 other locations) |
| Trial ID | NCT06709820 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and tolerability of the drug LY4060874 in healthy participants. The study will involve up to 22 weeks of participation, including approximately 16 study visits. Participants will receive either LY4060874 or a placebo to determine the drug's effects. The study is designed to ensure that participants meet specific health criteria and demographic backgrounds.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy individuals with a body mass index between 20 and 29.9 kg/m², of either Chinese or first-generation Japanese descent.
Not a fit: Patients with a history of diabetes or those who have recently used weight loss medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety profile of LY4060874, potentially leading to its use in future treatments.
How similar studies have performed: While this study focuses on a specific drug, similar studies evaluating the safety of new medications in healthy populations have shown success in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Are overtly healthy as determined by medical evaluation, including medical history and physical examination. * Have a body mass index in the range of 20 to 29.9 kilogram per meter squared (kg/m²), inclusive, at screening. * To qualify as Chinese for this study, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China. * To qualify as a participant of first-generation Japanese origin, the participant, the participant's biological parents, and all the participants' biological grandparents must be of exclusive Japanese descent and born in Japan. Exclusion Criteria: * Have a history of or have been diagnosed with Type 1 or Type 2 diabetes mellitus. * Have hemoglobin A1c (HbA1c) \> 6.4% or 46 millimoles/mole (mmol/mol) at screening. * Have taken approved, including over the counter (OTC) or prescribed, medication or investigational medication for weight loss, including GLP-1 receptor agonists, within the previous 3 months of study screening. * Have had surgical treatment for obesity. * Are actively participating in a weight loss program or intend to initiate an intensive diet and/or exercise program during the study.
Where this trial is running
Dallas, Texas and 1 other locations
- Fortrea, Inc. — Dallas, Texas, United States (Recruiting)
- Lilly Centre for Clinical Pharmacology — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
- Email: clinical_inquiry_hub@lilly.com
- Phone: 3176154559
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.