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Antisense Oligonucleotide

LY3473329 for Lipoprotein Disorder (KRAKEN Trial)

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
Participants must be at least 40 years old
High risk for cardiovascular events defined as documented coronary artery disease (CAD), stroke, or peripheral artery disease or atherosclerotic cardiovascular disease (ASCVD) risk equivalents (familial hypercholesterolemia or type 2 diabetes)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

KRAKEN Trial Summary

This trial studies if a new drug can reduce the risk of cardiovascular events in people with high levels of Lp(a).

Who is the study for?
Adults over 40 with high levels of Lp(a) and at high risk for heart-related events can join. They must have stable health conditions, be on a consistent medication regimen for at least 4 weeks, and agree to use contraception if applicable. Those with unstable medical conditions or recent major cardiovascular events cannot participate.Check my eligibility
What is being tested?
The trial is testing LY3473329 against a placebo to see if it's effective and safe in lowering the risk of heart problems in people with elevated Lp(a). Participants will randomly receive either the drug or a placebo while their health outcomes are monitored.See study design
What are the potential side effects?
Possible side effects of LY3473329 aren't detailed here but typically include reactions related to the immune system, liver function changes, muscle pain, kidney issues, or bleeding disorders based on similar medications.

KRAKEN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at least 40 years old.
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I have a high risk for heart problems due to conditions like CAD, stroke, or diabetes.

KRAKEN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 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 Lipoprotein (a) Lp(a)
Secondary outcome measures
Apolipoproteins B
Percent Change from Baseline for High Sensitivity C-reactive (hsCRP)
Percentage of Participants Achieving Lp(a) <125 Nanomole/Liter (nmol/L)
+1 more

KRAKEN Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3473329 Dose 3Experimental Treatment1 Intervention
Participants will receive LY3473329 orally.
Group II: LY3473329 Dose 2Experimental Treatment1 Intervention
Participants will receive LY3473329 orally.
Group III: LY3473329 Dose 1Experimental Treatment1 Intervention
Participants will receive LY3473329 orally.
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive placebo orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3473329
2021
Completed Phase 2
~350

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,612 Previous Clinical Trials
3,200,674 Total Patients Enrolled
1 Trials studying Lipoprotein Disorder
216 Patients Enrolled for Lipoprotein Disorder
Study DirectorEli Lilly and Company
1,343 Previous Clinical Trials
404,997 Total Patients Enrolled
1 Trials studying Lipoprotein Disorder
216 Patients Enrolled for Lipoprotein Disorder

Frequently Asked Questions

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

Has the U.S. Food & Drug Administration sanctioned LY3473329 Dose 1?

"With no data yet to support efficacy, our team at Power assigned LY3473329 Dose 1 a safety score of 2 due to the fact that it is currently in Phase 2 trials."

Answered by AI

What is the upper limit of individuals involved in this medical experiment?

"The sponsor Eli Lilly and Company needs a minimum of 233 participants to run the trial. These individuals must meet certain criteria, with trials happening at Meander Medisch Centrum in Amersfoort, Maryland; and Care Access - Baltimore in Baltimore Massachusetts."

Answered by AI

Can individuals currently enroll in this research project?

"Affirmative. Clinicaltrials.gov has information demonstrating that this investigation is open for recruitment, with the first posting taking place on November 24th 2022 and an update occurring September 4th 2023. 233 participants from 59 medical sites are required to complete the trial."

Answered by AI

What is the geographical extent of this experiment's management?

"Currently, this medical trial is being administered at 59 separate sites. Locations range from Amersfoort to Baltimore and Dorchester with multiple other centres in between. It's advised that participants opt for a nearby site so as not to be burdened by excessive travel requirements."

Answered by AI

Who else is applying?

What site did they apply to?
Care Access - Dorchester
What portion of applicants met pre-screening criteria?
Did not meet criteria
~100 spots leftby Apr 2025