A Study of LY4088044 in Healthy Participants
Launched by ELI LILLY AND COMPANY · Jul 28, 2025
Trial Information
Current as of August 19, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medicine called LY4088044 to see how well healthy people tolerate it and to learn about any side effects. The medicine will be given either by injection under the skin or directly into a vein in the arm. During the study, blood tests will be done to find out how the body absorbs and gets rid of the medicine over time.
The study is looking for healthy adults who meet certain health requirements, such as having a body weight within a normal range and no serious health problems. People who are pregnant, use certain drugs, have heart issues, or smoke heavily may not be able to participate. The study will last up to about 92 weeks, and participants can expect to have regular medical check-ups and blood tests throughout this time. This research helps doctors understand how safe the medicine is before it is tested in patients with specific illnesses.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and cardiac monitoring
- • Have a body mass index (BMI) within the range 18.5 to 30 kilogram per square meter (kg/m²)
- Exclusion Criteria:
- • Are individuals assigned female at birth (AFAB) who are pregnant and/or lactating
- • Regularly use known drugs of abuse or show positive findings on urinary drug screening that are not consistent with their medication history
- • Participants with hemoglobin less than 12 gram per deciliter (g/dl) for females or less than 14 milligram per deciliter (mg/dl) for males, or evidence of iron deficiency, or hemoglobinopathy
- • Participants with estimated glomerular filtration rate (GFR) less than 90 milliliter per minute per 1.73 square meter (mL/min/1.73 m²)
- • Have a 12-lead electrocardiogram (ECG) abnormality
- • Smoke more than 10 cigarettes per day or the equivalent including electronic cigarettes AND are unable to abide by investigative site smoking restrictions
- • Have an average weekly alcohol intake that exceeds 21 units per week (males less than or equal to 65 years old) and 14 units per week (females and males over 65-year-old, if applicable) and are unwilling to abide by the restrictions
About Eli Lilly And Company
Eli Lilly and Company is a global healthcare leader dedicated to creating innovative medicines that improve patient outcomes across a range of therapeutic areas, including diabetes, oncology, immunology, and neurodegenerative diseases. With a rich history of scientific research and a commitment to advancing healthcare, Lilly invests significantly in clinical trials to develop new treatments and enhance existing therapies. The company prioritizes patient safety and ethical standards in its clinical research, fostering collaboration with healthcare professionals and stakeholders to ensure the delivery of high-quality, evidence-based solutions that address unmet medical needs worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Salt Lake City, Utah, United States
Los Alamitos, California, United States
Patients applied
Trial Officials
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Study Director
Eli Lilly and Company
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported