Lipid Disorder Clinical Trials

Older African American woman is embraced by her daughter over the shoulders. Lipid disorders cause abnormal levels of lipids or fats in the bloodstream. Known as low-density lipoproteins (LDLs) or bad cholesterol and triglycerides, these levels can increase and accumulate in the body’s tissues and arteries, which could jeopardize cardiovascular health and lead to disease.

Familial Hypercholesterolemia, or FH, an inherited genetic disorder that affects how the body handles cholesterol, can generate very high LDL-cholesterol level, and place individuals at risk of a heart attack and stroke.

Our clinical trials will evaluate the effectiveness of novel treatments as well as observe outcomes over time.

Through the Cardiovascular Disease Prevention and Advanced Lipid Clinic, genetic testing is used to confirm diagnoses, adjust treatments and provide family screening.

Current Clinical Trials

The following cardiovascular clinical trials are led by physician scientists who are part of the Krannert Cardiovascular Research Center at the IU School of Medicine.

ACCLAIM STUDY: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)

Objective: To demonstrate whether Lepodisiran is superior to placebo in reducing the risk of the composite endpoint of MACE-4, defined as CV death nonfatal myocardial infarction nonfatal stroke, and urgent coronary revascularization.

PI: Julie M. Clary, MD

Status: Now Enrolling

NCT No. NCT06292013

Registry: Cascade registry by Family Heart Foundation

Objective: To promote awareness of Familial Hypercholesterolemia (FH) prevalence through the development and implementation of an FH registry.

PI: Julie M. Clary, MD

Status: Registry

NCT No. NCT01960244

HORIZON STUDY: Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD (Lp(a)HORIZON)

PI: Julie M. Clary, MD

Status: Active, not recruiting. Monitoring participants.

NCT No. NCT04023552

Lipoprotein(a) Lowering of Pelacarsen (TQJ230) in U.S. Black/African American and Hispanic Participants with Elevated Lp(a) and Established ASCVD

Objective: Randomized, double-blind, placebo-controlled multicenter trial to evaluate the efficacy, safety and tolerability of Pelacarsen (TQJ230) in U.S. Black/African American and Hispanic patient populations with elevated Lipoprotein (a) and established Atherosclerotic Cardiovascular Disease.

PI: Julie M. Clary, MD

Status: Not yet recruiting locally. Other sites open. See NCT link for locations.

NCT No. NCT06267560

Email the clinical research team to learn more and participate

Principal Investigator