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NCT06292013 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a)
A Phase 3 study of Atherosclerotic Cardiovascular Disease (ASCVD) and Elevated Lp(a), sponsored by Eli Lilly and Company.
- Active
- Registry status
- Phase 3
- Development phase
- 17,300
- Enrollment target
- 20
- Study locations
NCT06292013: Active Phase 3 study of Atherosclerotic Cardiovascular Disease (ASCVD) and Elevated Lp(a), sponsored by Eli Lilly and Company.
NCT06292013 is a Phase 3 study of Atherosclerotic Cardiovascular Disease (ASCVD) and Elevated Lp(a) that is active but no longer recruiting, run by Eli Lilly and Company. The registered enrollment target is 17,300 participants, above the 5,228-participant average among 4 other Atherosclerotic Cardiovascular Disease (ASCVD) trials with a reported enrollment target (231% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06292013, a Phase 3 study of Atherosclerotic Cardiovascular Disease (ASCVD) and Elevated Lp(a), is active but no longer recruiting, sponsored by Eli Lilly and Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 17,300 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. The study drug will be administered subcutaneously (SC) (under the skin). Approximately 1700 additional participants will be enrolled in an addendum to explore Lp(a) lowering with an alternative dosing schema.
Primary Outcome
Time to first event in a MACE-4 composite endpoint, comprised of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent coronary revascularization.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lepodisiran Sodium
Study Locations (20)
Arizona
- Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC - Gilbert
- Mercy Gilbert Medical Center - Gilbert
- Sun City Clinical Research - Glendale
- Elite Clinical Studies, LLC - Phoenix
- Helios Clinical Research - Phoenix - Phoenix
- Absolute Clinical Research - Phoenix
- Clinical Research Institute of Arizona (CRI) - Sun City West - Sun City West
- Pima Heart - Tucson
- Synexus Clinical Research US, Inc./Orange Grove Family Practice - Tucson
- Eclipse Clinical Research - Tucson
Alabama
- Birmingham Clinical Research - Birmingham
- Alliance for Multispecialty Research, LLC - Daphne
- SEC Clinical Research - Dothan
- Alliance for Multispecialty Research, LLC - Mobile
- Mobile Heart Specialists - Mobile
California
- National Heart Institute - Beverly Hills
- Valley Clinical Trials, Inc. - Covina
- Neighborhood Healthcare Institute of Health - Escondido
- HB Clinical Trials - Fountain Valley - Fountain Valley
Arkansas
- Cardiology and Medicine Clinic - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17,300 participants |
| Start Date | 2024-03-05 |
| Est. Completion | 2029-03 |
| Phase | Phase 3 |
What the registry record for NCT06292013 still lists
NCT06292013 is an interventional study that assigns participants to a tested intervention. Its 17,300 participants enrollment target places it among the larger protocols in the corpus, above the 5,228-participant average among 4 other Atherosclerotic Cardiovascular Disease (ASCVD) trials with a reported enrollment target (231% higher).
The record links to 2 conditions, with Atherosclerotic Cardiovascular Disease (ASCVD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06292013 names 20 study sites across 4 states, led by Arizona, Alabama, California.
Frequently Asked Questions
What is clinical trial NCT06292013 about?
NCT06292013 is a clinical study titled "A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a)". The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. The study drug will be administered subcutaneously (SC) (under the skin). Approxim...
What is the current status of trial NCT06292013?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 17,300 participants. The study started on 2024-03-05. Estimated completion is 2029-03.
What conditions does trial NCT06292013 study?
This clinical trial studies the following conditions: Atherosclerotic Cardiovascular Disease (ASCVD), Elevated Lp(a).
What interventions are being tested in trial NCT06292013?
The interventions under investigation include: Placebo (DRUG), Lepodisiran Sodium (DRUG).
Who is sponsoring clinical trial NCT06292013?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06292013 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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