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ACCLAIM-Lp(a) Phase III trial - coming soon!

Primary indication   

Investigation of the effect of the drug lepodisiran on the reduction of serious adverse cardiovascular events in adults with elevated lipoprotein(a)
 

Study name (study type)

ACCLAIM-Lp(a) 

 

Study sponsor

Lilly

 

Registration number

EU Trial Number: 2023-509190-23-00

 

FOR RAPID READERS:

This is a Phase III study investigating the effect of the drug lepodisiran on the reduction of serious adverse cardiovascular events in adults with elevated lipoprotein(a).

 

DETAILED INFORMATION

The purpose of this study is to evaluate the effectiveness of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of heart attack or stroke. The study drug is administered under the skin (subcutaneously).

 

Study Title

J3L-MC-EZEF – ClinicalTrials.gov – NCT06292013

 

Which conditions are being treated in this study?

Atherosclerotic cardiovascular disease

Elevated lipoprotein(a)

Elevated cholesterol

 

Background on the study medication

Results from a Phase 1 study of lepodisiran: in 48 participants with elevated Lp(a), a single dose led to a dose-dependent reduction in Lp(a) of up to 97% after 168 days. Results from the Phase 2 study involving 254 individuals with elevated Lp(a) are expected by the end of 2024.

 

Study Protocol

  • The study drug is administered under the skin (subcutaneously). 

  • This study is placebo-controlled.

  • Participation is expected to last 4 to 5 years.

 

Inclusion criteria

  • Lp value ≥ 175 nmol/L 
  • Minimum age of 18 years 
  • Atherosclerotic cardiovascular disease, heart attack, or stroke ≥ 90 days
  • Stable use of cholesterol-lowering medication

 

Exclusion criteria

  • You have had a serious cardiovascular event or surgical procedure, e.g., a heart attack, stroke, or coronary or peripheral revascularization < 90 days

  • Lp(a) < 175 nmol/L

  • No cholesterol-lowering medication

  • Severe heart failure

  • Very high, uncontrolled blood pressure
  • Severe renal insufficiency with or without dialysis
  • Chronic liver problems
  • Cancer

 

Your contacts: Investigators at the center and contact information

Chief Physician Dr. Oliver Koeth

Staff members responsible for the study clinic:

Heike Borchert (Study Coordinator)

Email: borchert@~@gp-ruesselsheim.de

Phone: 06142 88-1032

Clinical studies and medical documentation