A Study of LY4088044 in Healthy Participants
ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEli Lilly and Company
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
LY4088044
DrugAdministered IV
LY4088044
DrugAdministered SC
Placebo
DrugAdministered IV
Placebo
DrugAdministered SC
Treatment groups
104 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: LY4088044 (Part A)Experimental treatment 1 intervention
Group B: Placebo (Part A)Placebo comparator 1 intervention
Group C: LY4088044 (Part B)Experimental treatment 1 intervention
Group D: Placebo (Part B)Placebo comparator 1 intervention
Group E: LY4088044 (Part C)Experimental treatment 1 intervention
Group F: Placebo (Part C)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
Time frame
Baseline up to Approximately Day 190Secondary outcomes
1
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4088044
PK: Cmax of LY4088044
Time frame
Baseline up to Approximately Day 1902
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4088044
PK: AUC of LY4088044
Time frame
Baseline up to Approximately Day 1903
Pharmacodynamics (PD): Protein Levels in Skin Samples
PD: Percent Decrease in Protein Levels
Time frame
Baseline up to Approximately Day 190Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov