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Monoclonal Antibodies

LY3819469 for Lipoprotein Disorder

Phase 2
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 days 60, 180, 240, 360, and 540
Awards & highlights

Study Summary

This trial will test a new drug to see if it can lower levels of lipoprotein(a) in adults. The study will last 20 months.

Who is the study for?
Adults over 40 with a BMI of 18.5-40 kg/m² and high lipoprotein(a) levels (≥175 nmol/L) can join this trial. They must be on stable medication regimens if taking lipid-lowering drugs or hormones, and agree to use contraception if necessary. Those with uncontrolled diabetes, hypertension, unstable medical conditions, or any condition that could affect safety or study results are excluded.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of LY3819469 compared to a placebo in adults with elevated lipoprotein(a). Participants will receive either the investigational drug or a placebo for about 20 months to see how it affects their condition.See study design
What are the potential side effects?
Specific side effects of LY3819469 aren't provided here but generally may include reactions at the injection site, potential liver issues due to changes in fat metabolism, muscle pain or weakness from statin-like effects, and possible allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 60, 180, 240, 360, and 540
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 60, 180, 240, 360, and 540 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Change from Baseline in Time Averaged Lipoprotein(a) [Lp(a)]
Secondary outcome measures
Percent Change from Baseline in Apolipoprotein B (ApoB)
Percent Change from Baseline in High-sensitivity C-reactive Protein (hsCRP)
Percent Change from Baseline in Lp(a)
+3 more

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3819469 Dose 4 + PlaceboExperimental Treatment2 Interventions
Participants will receive LY3819469 SC and placebo.
Group II: LY3819469 Dose 3Experimental Treatment1 Intervention
Participants will receive LY3819469 SC.
Group III: LY3819469 Dose 2Experimental Treatment1 Intervention
Participants will receive LY3819469 SC.
Group IV: LY3819469 Dose 1Experimental Treatment1 Intervention
Participants will receive LY3819469 subcutaneously (SC).
Group V: PlaceboPlacebo Group1 Intervention
Participants will receive placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3819469
2023
Completed Phase 1
~120
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,615 Previous Clinical Trials
3,200,842 Total Patients Enrolled
1 Trials studying Lipoprotein Disorder
233 Patients Enrolled for Lipoprotein Disorder
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
405,036 Total Patients Enrolled
1 Trials studying Lipoprotein Disorder
233 Patients Enrolled for Lipoprotein Disorder

Media Library

LY3819469 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05565742 — Phase 2
Lipoprotein Disorder Research Study Groups: LY3819469 Dose 1, LY3819469 Dose 2, LY3819469 Dose 3, LY3819469 Dose 4 + Placebo, Placebo
Lipoprotein Disorder Clinical Trial 2023: LY3819469 Highlights & Side Effects. Trial Name: NCT05565742 — Phase 2
LY3819469 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05565742 — Phase 2

Frequently Asked Questions

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

Are there any remaining vacancies for volunteers in this experiment?

"The listed status on clinicaltrials.gov is "ACTIVE, not recruiting". The trial was initially posted on October 21st, 2020 and has not been updated since."

Answered by AI

Has the FDA cleared LY3819469 Dose 1 for use?

"LY3819469 Dose 1 is currently being trialled in Phase 2, which means that while there is some evidence supporting its safety, there is no data to show whether or not it is effective. Our team has rated its safety as a 2."

Answered by AI

If this trial is successful, will it be adopted by other clinics in the United States?

"There are a total of 17 locations for this trial, which include Care Access - Tampa in Tampa, Florida, Care Access - Lima in Lima, Ohio, and Care Access - Pebble Beach Boulevard, Tampa in Sun City, Pennsylvania among others."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
What site did they apply to?
Care Access - Lima
Care Access - Dorchester
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of LY3819469 in Participants With Elevated Lipoprotein(a) [Lp(a)]
2022. "A Study of LY3819469 in Participants With Elevated Lipoprotein(a) [Lp(a)]". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05565742.
~89 spots leftby Apr 2025
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