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LY3462817 (SC) 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 through day 85
Awards & highlights

Study Summary

This trial will assess the safety and tolerability of LY3462817 in healthy Japanese and non-Japanese participants. It will also study how LY3462817 is metabolized by the body. The trial is open to healthy participants and will last up to 12 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose on day 1 through day 85
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose on day 1 through day 85 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Secondary outcome measures
PK: Maximum Concentration (Cmax) of LY3462817
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3462817

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3462817 - SCExperimental Treatment1 Intervention
LY3462817 administered subcutaneously (SC)
Group II: LY3462817 - IVExperimental Treatment1 Intervention
LY3462817 administered intravenously (IV)
Group III: Placebo - IVPlacebo Group1 Intervention
Placebo administered IV
Group IV: Placebo - SCPlacebo Group1 Intervention
Placebo administered SC
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3462817 (IV)
2022
Completed Phase 1
~40
LY3462817 (SC)
2022
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,613 Previous Clinical Trials
3,200,896 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
405,219 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being accepted into this research endeavor?

"Affirmative. According to the information presented on clinicaltrials.gov, this medical trial is presently in need of participants and was first published on June 28th 2022. It has been updated as recently as July 7th 2022 and requires 32 individuals from 1 centre for recruitment purposes."

Answered by AI

Has the Food and Drug Administration recognized LY3462817 (SC) as a viable therapeutic?

"Due to the limited evidence of efficacy and safety, our team determined that LY3462817 (SC) should be given a score of 1 on a scale from 1-3."

Answered by AI

Does this scientific research permit participants aged over forty?

"As specified by the criteria for this study, participants must be between 18 and 65 years of age in order to qualify."

Answered by AI

Are there any available slots for participation in this research project?

"Affirmative. Clinicaltrials.gov shows that this clinical trial is presently recruiting participants, which it first advertized on June 28th 2022 and updated most recently on July 7th 2022. The study needs to enroll 32 people across a single site."

Answered by AI

Who is eligible to partake in this clinical experiment?

"This trial is searching for 32 healthy participants aged 18-65. Regardless of nationality, applicants must have a BMI between 18 and 30 kg/m² (inclusive) with body weight no less than 45kg or more than 85 kg. In addition to being in general good health as determined by medical evaluation, male participants are required to abide by contraception regulations while non-childbearing females can be accepted into the study. Furthermore, blood pressure, pulse rate, ECG tracing results must also meet acceptable standards set out by the research team."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Altasciences Clinical Los Angeles, Inc
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Safety Study of LY3462817 in Healthy Japanese and Non-Japanese Participants
2022. "A Safety Study of LY3462817 in Healthy Japanese and Non-Japanese Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05440136.
~12 spots leftby Apr 2025
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