Purpose of this Study
In this study, people will visit the clinic about every twelve weeks for checkups, lab tests, and other health exams. At each visit, they will receive a shot under the skin. The shot will either contain the study medicine, called olpasiran, or a placebo, which is a shot with no medicine in it. Participants are placed into one of these two groups by chance, like flipping a coin, and neither the doctor nor the participant will know which one they are getting.
The study will last for several years. During this time, the team will check blood tests, look at heart health, and watch for any side effects. The main goal is to learn if olpasiran can safely lower Lp(a) levels and help prevent serious heart problems in the future.
Who Can Participate?
Eligibility
People can join this study if they are at least 50 years old and have a high amount of lipoprotein(a), also called Lp(a), in their blood. Their Lp(a) level must be 200 nmol/L or higher. They must also have health conditions that make heart disease more likely, such as high blood pressure, diabetes, smoking, kidney disease, or a family history of early heart problems. They can also join if tests show plaque building up in their arteries. They must have been taking the same cholesterol‑lowering medicine for at least four weeks before joining and must never have had a major heart problem like a heart attack, stroke, or a procedure to open blocked arteries.
Age Range
50-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study wants to find out if a medicine called olpasiran can lower a type of fat in the blood called lipoprotein(a), or Lp(a). When Lp(a) is too high, it can increase a person’s chance of having heart disease. The goal of the study is to see if lowering Lp(a) can help stop someone from having their first major heart problem, such as a heart attack. By doing this research, doctors hope to learn better ways to protect people with high Lp(a) from heart disease in the future.
Locations
Duke University Hospital
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants with Elevated Lipoprotein(a)
Principal Investigator
Nishant
Shah
Protocol Number
PRO00118364
NCT ID
NCT07136012
Phase
III
Enrollment Status
Pending Open to Enrollment