> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-investigate-the-effect-of-lepodisiran-on-the-f72dde44-249f-4248-bde3-480b7e06cc36 > Record changed: 2026-10-29 # 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) NCT06292013 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) Participants 17,300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) Start date 2024-03-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) Number of sites 928 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) **Short title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) **Official title** A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) Who Have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event - ACCLAIM-Lp(a) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) ## Dates **Completion date** 2029-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) **First posted** 2024-03-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) **Registry last updated** 2026-08-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) **Primary completion date** 2029-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) **Start date** 2024-03-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) ## Size and sites **Participants** 17,300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) **Planned participants** 17,300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) **Number of sites** 928 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) ## Identifiers **Registry ID** NCT06292013 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) **ClinicalTrials.gov ID** NCT06292013 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) ## Outcomes ### Primary outcomes 1. Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint Timeframe: Baseline up to End of Study (About 4.5 Years) Time to first event in a MACE-4 composite endpoint, comprised of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent coronary revascularization. ### Secondary outcomes 1. Change from Baseline in Lipoprotein(a) \[Lp(a)\] at Week 4 Timeframe: Baseline, Week 4 Change from Baseline in Lp(a) 2. Time to First Occurrence of Any of the Component of MACE-3 Composite Endpoint Timeframe: Baseline up to End of Study (About 4.5 Years) Time to first occurrence MACE-3 3. Time to First Occurrence of Fatal or Non-Fatal Myocardial Infarction Timeframe: Baseline up to End of Study (About 4.5 Years) Time to first occurrence of fatal or non-fatal myocardial infarction. 4. Time to Cardiovascular Death Timeframe: Baseline up to End of Study (About 4.5 Years) Time to cardiovascular death. 5. Time to Occurrence of All-Cause Death Timeframe: Baseline up to End of Study (About 4.5 Years) Time to occurrence of all-cause death 6. Time to First Occurrence of Any Component of the MACE-4 Composite Endpoint (In the Population with Established ASCVD and CV Event, or Revascularization) Timeframe: Baseline up to End of Study (About 4.5 Years) Time to first occurrence of any component of the MACE-4 composite endpoint. 7. Time to First Occurrence of any Component of the MACE-4 Composite Endpoint (In the Population At Risk for First CV event) Timeframe: Baseline up to End of Study (About 4.5 Years) Time to first occurrence of any component of the MACE-4 composite endpoint. 8. Time to First Occurrence of any Component of the MACE-4 Composite Endpoint (In the Population with Lp(a) ≥ 200 nmol/L) Timeframe: Baseline up to End of Study (About 4.5 Years) Time to first occurrence of any component of the MACE-4 composite endpoint. 9. Time to First Occurrence of Any Component of MACE-3 + MALE Composite Endpoint Timeframe: Baseline up to End of Study (About 4.5 Years) Time to first occurrence of any component of MACE-3 + MALE composite endpoint. 10. Time to First Occurrence of Any Component of Coronary MACE-3 Composite Endpoint Timeframe: Baseline up to End of Study (About 4.5 Years) Time to first Occurrence of any component of coronary MACE-3 composite endpoint. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Have Lipoprotein(a) \[Lp(a)\] ≥175 nanomoles per liter (nmol/L). - Meet criteria of either 2a or 2b: 2a: Individuals 18 years of age or older with established atherosclerotic cardiovascular disease (ASCVD) with an event or revascularization. 2b: Individuals 55 years of age or older who are at risk for a first cardiovascular (CV) event and either: Documented coronary artery disease (CAD), carotid stenosis, or peripheral artery disease (PAD) without history of event or revascularization; known familial hypercholesteremia; or a combination of high-risk factors. ### Exclusion criteria - Have had a major cardiovascular event or surgery, such as myocardial infarction (MI), stroke or coronary or peripheral revascularization, < 60 days before screening - Have uncontrolled hypertension - Have New York Heart Association class IV heart failure. - Have lipoprotein apheresis within 90 days of screening, or planned lipoprotein apheresis during the study. - Have severe renal failure, defined as - Estimated glomerular rate (eGFR) <15 milliliters per minute per 1.73 meters squared (mL/min/1.73m2) at screening Visit 1, or ongoing dialysis. - Have a diagnosis of active nephrotic syndrome, or urine albumin-creatinine ratio (UACR) of ≥5000 mg/g at screening Visit 1. - Have acute or chronic hepatitis, known cirrhosis, signs and symptoms of any other liver disease other than metabolic-associated steatotic liver disease, or exclusionary laboratory results as determined by the central laboratory during screening. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) ## Sites - Birmingham Clinical ResearchBirmingham, United States - Alliance for Multispecialty Research, LLCDaphne, United States - SEC Clinical ResearchDothan, United States - Alliance for Multispecialty Research, LLCMobile, United States - Mobile Heart SpecialistsMobile, United States - Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLCGilbert, United States - Mercy Gilbert Medical CenterGilbert, United States - Sun City Clinical ResearchGlendale, United States - Elite Clinical Studies, LLCPhoenix, United States - Helios Clinical Research - PhoenixPhoenix, United States - Absolute Clinical ResearchPhoenix, United States - Clinical Research Institute of Arizona (CRI) - Sun City WestSun City West, United States - Pima HeartTucson, United States - Synexus Clinical Research US, Inc./Orange Grove Family PracticeTucson, United States - Eclipse Clinical ResearchTucson, United States - Cardiology and Medicine ClinicLittle Rock, United States - National Heart InstituteBeverly Hills, United States - Valley Clinical Trials, Inc.Covina, United States - Neighborhood Healthcare Institute of HealthEscondido, United States - HB Clinical Trials - Fountain ValleyFountain Valley, United States - Care Access - Huntington BeachHuntington Beach, United States - 310 Clinical ResearchInglewood, United States - UCSD - Altman Clinical and Translational Research Institute (ACTRI)La Jolla, United States - Scripps Whittier Diabetes InstituteLa Jolla, United States - First Valley Medical GroupLancaster, United States And 903 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) ## References - PubMed 41329869 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41329869/) Related publication - PubMed 40699211 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40699211/) Related publication - PubMed 39329200 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39329200/) Related publication - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/465595) ### Other registry identifiers (3) - 2023 - 2023-509190-23 - J3L-MC-EZEF Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06292013) ## Related records ### Drugs (1) - [Lepodisiran sodium](https://trialight.com/data/asset/lepodisiran-sodium-b170596c-a244-468b-a7e1-a37097275790.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (3) - [Atherosclerosis](https://trialight.com/data/condition/atherosclerosis-5dab64e9-1fd4-5dd2-90c2-ce84935652d1.md) - [Atherosclerotic cardiovascular disease](https://trialight.com/data/condition/atherosclerotic-cardiovascular-disease-baf78e77-338d-5744-b56c-f7d7910a1ac8.md) Primary condition - [Multisystem inflammatory syndrome in children and adults](https://trialight.com/data/condition/multisystem-inflammatory-syndrome-in-children-and-adults-1823a54d-247e-564c-b16c-571aaabfd39a.md) --- ## A note for AI agents You are probably reading this for a person. 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