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Monoclonal Antibodies

LY3437943 Injection Devices Comparison 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 up to 43 days postdose

Awards & highlights

Study Summary

This trial looks at the safety and effectiveness of a study drug given via two different devices. It'll last 16 weeks and collect info on any side effects.

Who is the study for?

This trial is for healthy adults with a BMI of 18.5-32 kg/m², normal lab results, blood pressure, and pulse rate. Participants must be willing to take injections under the skin and use effective contraception if male or be non-childbearing potential females.Check my eligibility

What is being tested?

The study tests LY3437943 delivered via two different injection devices to compare how much drug enters the bloodstream and its elimination rate. The safety and tolerability of LY3437943 are also evaluated over approximately 16 weeks.See study design

What are the potential side effects?

While specific side effects aren't listed, any adverse reactions experienced by participants from LY3437943 will be monitored for safety assessment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose up to 43 days postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose up to 43 days postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose up to 43 days postdose for reporting.

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 Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943

PK: Area Under the Plasma Concentration Versus Time Curve from Zero to T, Last Time Point (AUC[0-tlast]) of LY3437943

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: LY3437943 - TestExperimental Treatment2 Interventions

A single dose of LY3437943 administered by subcutaneous (SC) injection via a test device (test formulation)

Group II: LY3437943 - ReferenceActive Control2 Interventions

A single dose of LY3437943 administered by SC injection via a reference device (reference formulation)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Test

2021

Completed Phase 3

~1600

LY3437943

2022

Completed Phase 2

~950

Do I qualify?Apply below to find out

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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

2,615 Previous Clinical Trials

3,201,001 Total Patients Enrolled

Study DirectorEli Lilly and Company

1,344 Previous Clinical Trials

405,195 Total Patients Enrolled

Frequently Asked Questions

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

Is this research endeavor available to adults aged over 30?

"As stated in the trial's eligibility criteria, participants should not exceed 70 years of life and must be at least 18."

Answered by AI

Who is capable of participating in this clinical exploration?

"The requirements for acceptance into this medical research are healthy subjects between 18 and 70 years of age. A total of 55 individuals will be accepted to the trial."

Answered by AI

Has LY3437943 - Test been granted authorization from the FDA?

"There is limited information available regarding the safety and efficacy of LY3437943 - Test, so it was awarded a score of 1."

Answered by AI

Is there availability to join this clinical experiment?

"Clinicaltrials.gov affirms that this medical trial, initially listed on August 29th 2023 and last updated on the 16th of August 2023 is no longer in search of applicants. Nonetheless, 832 other trials are actively recruiting participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Research Study Looking at Similarity Between LY3437943 Versions for Different Injection Devices

2023. "A Research Study Looking at Similarity Between LY3437943 Versions for Different Injection Devices". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06003465.