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Recruiting Phase 1 NCT07090785

A Study of LY4088044 in Healthy Participants

Phase 1 – testing safety in a small group of people
Conditions: Healthy

Sponsor: Eli Lilly and Company

trial.available_in: БГ
Overview
The purpose of this study is to evaluate how well LY4088044 is tolerated and what side effects may occur in healthy participants. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4088044 gets into the bloodstream and how long it takes the body to eliminate it. The study will last up to approximately 92 weeks for Parts A, B, and C, excluding screening.
Who can participate
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 outside of the local laboratory normal range for age and gender, 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
Interventions
LY4088044
DRUG
LY4088044
DRUG
Placebo
DRUG
Placebo
DRUG
Locations 6
New Zealand (1)
New Zealand Clinical Research Christchurch
Christchurch
NOT_YET_RECRUITING
Singapore (1)
Lilly Centre for Clinical Pharmacology
Singapore
United States (4)
ICON
Lenexa , Kansas
NOT_YET_RECRUITING
Collaborative Neuroscience Network - CNS
Los Alamitos , California
NOT_YET_RECRUITING
ICON
Salt Lake City , Utah
ICON Early Phase Services
San Antonio , Texas
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
24.07.2025
Completion date
01.07.2027
Registry ID
NCT07090785
Source
clinicaltrials.gov
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.