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LY3454738 (Reference Formulation) for Healthy Subjects
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 predose on day 1 up to 85 days post dose
Awards & highlights
Study Summary
This trial will test the safety, dose, and effectiveness of a new drug and measure how long it stays in the body. It will last about 17 wks.
Who is the study for?
This trial is for healthy individuals who are interested in helping to test a new drug called LY3454738. Participants will be involved in the study for about 17 weeks, including screening time.Check my eligibility
What is being tested?
The study is testing how much of the drug LY3454738 enters the bloodstream and how quickly it's eliminated when administered under the skin. It compares two different formulations of this drug.See study design
What are the potential side effects?
While specific side effects aren't listed, participants' safety and tolerance to LY3454738 will be monitored, with any experienced side effects being recorded throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose on day 1 up to 85 days post dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose on day 1 up to 85 days post dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3454738
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3454738
Trial Design
2Treatment groups
Experimental Treatment
Group I: LY3454738 (Test Formulation)Experimental Treatment1 Intervention
Group II: LY3454738 (Reference Formulation)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3454738
2018
Completed Phase 1
~130
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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
2,624 Previous Clinical Trials
3,216,894 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,349 Previous Clinical Trials
415,650 Total Patients Enrolled
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