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Monoclonal Antibodies
A Study of LY3819469 in Healthy Participants
Phase 1
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to week 49
Summary
This trial is testing a new medication called LY3819469. It aims to see if the drug is safe and how it affects healthy people with high levels of a specific blood fat and Japanese participants. Researchers want to understand how the body processes the drug and its impact on blood fat levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to week 49
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to week 49
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Secondary study objectives
PK: Maximum Observed Drug Concentration (Cmax) of LY3819469
Pharmacodynamics (PD): Change From Baseline in Fasting Lp(a)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3819469
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3819469 (Part B)Experimental Treatment1 Intervention
Single doses of LY3819469 administered SC in Japanese Participants.
Group II: LY3819469 (Part A)Experimental Treatment1 Intervention
Single ascending doses of LY3819469 administered subcutaneously (SC).
Group III: Placebo (Part B)Placebo Group1 Intervention
Placebo administered SC.
Group IV: Placebo (Part A)Placebo Group1 Intervention
Placebo administered SC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3819469
2023
Completed Phase 1
~120
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,679 Previous Clinical Trials
3,465,687 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,389 Previous Clinical Trials
428,102 Total Patients Enrolled