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NCT Number: NCT07613294

A Study to See if Lepodisiran Can Reduce Plaque in Coronary Arteries of Adults With Elevated Lp(a) Who Have Had Heart Events or Are at High Risk

Lipoprotein(a), also known as Lp(a), is a protein that carries cholesterol and proteins in your blood. People with high Lp(a) have a higher risk for heart disease. The main purpose of the study is to investigate how lepodisiran, compared to a placebo, affects the amount and type of plaque in the heart's vessels using an imaging technology known as Coronary Computed Tomography Angiography (CCTA) in adults who have high levels of Lp(a).

Participation will last about 120 weeks.

Recruiting

Interested in participating?

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Lipoprotein(a) Vascular Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nightingale Research, Adelaide, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have an Lp(a) ≥175 nmol/L
  • Have established cardiovascular (CV) disease or are at risk for a first CV event
  • Have angiographic evidence of coronary artery disease on screening CCTA
  • If taking lipid-lowering medications, inclusive of statins or prescription strength niacin and PCSK9 inhibitors, these should be stable for 8 weeks

Exclusion criteria

  • Have had a major CV event less than 60 days before measurement of the Lp(a) level used for eligibility or uncontrolled high blood pressure at screening
  • Have moderate to severe renal dysfunction
  • Have severe heart failure
  • Have a history of coronary artery bypass graft surgery (CABG)
  • Have a planned coronary angiography, percutaneous coronary intervention (PCI), coronary artery bypass graft, or valvular intervention
  • Have had a procedure to remove lipoproteins from the blood or received therapy specifically targeting Lp(a)
  • Are unable to safely undergo CCTA due to medication intolerance, contrast allergies, or anatomical/technical factors

Treatment and study plan

Lepodisiran

Drug

Administered SC

Other names: LY3819469

Placebo

Drug

Administered SC

Primary outcomes

  1. Percent Change from Baseline in Noncalcified Plaque (NCP) Volume

    Time frame: Baseline, Week 104

Secondary outcomes

  1. Percent Change from Baseline in Mean Fat Attenuation Index (FAI) Score

    Time frame: Baseline, Week 104

  2. Percent Change from Baseline in Lp(a) Level

    Time frame: Baseline through Week 104

  3. Percentage of Participants Reporting Strongly Agree or Agree on the Subcutaneous Administration Assessment Questionnaire (SQAAQ) Version 3.0 Items

    Time frame: Week 26, Week 78

  4. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3819469

    Time frame: Predose through Week 52

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of Lepodisiran to Investigate the Effect on Coronary Plaque in Adults With Elevated Lp(a) Who Have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event

Acronym: ACCLAIM-CTA

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 29, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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