A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4088044 in Healthy Participants

What this Trial Is About

Researchers are evaluating LY4088044, a drug given either under the skin subcutaneously or into a vein intravenously, to see how well it is tolerated and to identify any side effects in healthy adults. This Phase 1 study is sponsored by Eli Lilly and Company and focuses on assessing the safety, how the drug moves through and is processed by the body, and its effects. The study is designed to include single and multiple increasing doses to better understand LY4088044s behavior in the body. The study includes three parts Part A and Part B involve single ascending doses of LY4088044 given intravenously or subcutaneously, while Part C includes multiple ascending doses given intravenously. Participants may receive either the study drug LY4088044 or a placebo, with treatment assignments made randomly and the study conducted in a double-blind manner. The drug is administered using injections either under the skin or into the vein. Participants will be monitored for up to approximately 92 weeks, excluding screening. Throughout the study, blood tests will be performed to measure how much LY4088044 enters the bloodstream and how quickly it is eliminated. Researchers will also monitor for serious side effects possibly related to the drug, and assess protein levels in skin samples. Safety checks include medical exams, vital signs, laboratory tests, and cardiac monitoring. The main outcome is the number of serious adverse events related to the study drug occurring up to about 190 days after dosing.

A Study of LY4088044 in Healthy Participants