Help shape the future of high triglyceride treatment
If you have a medical history of very high triglyceride levels, you may be eligible to take part in the Pulse-1 study.
About the Pulse-1 study
The Pulse-1 study is a Phase 1b clinical trial enrolling people who have severe hypertriglyceridemia. The Pulse-1 study will help determine if a single dose of an investigational medicine, called VERVE-201, can safely and durably reduce triglyceride levels in people whose levels remain high, even after making recommended lifestyle changes and taking currently available triglyceride-lowering medicines (such as fibrates, omega 3 fatty acids, or niacin).
Up to 36 people in several countries will be enrolled in the Pulse-1 study. Participants will be involved in the trial for up to one year after receiving VERVE-201. After the study is over, participants are expected to join a long-term follow-up study to help researchers understand the safety of VERVE-201 over a longer period. The study doctor will share more details about this study with you.
About the investigational medicine
VERVE-201, the investigational gene editing medicine, is given as a single intravenous (IV) infusion into a vein in the arm. VERVE-201 targets a specific gene in the liver, called ANGPTL3. This gene makes the ANGPTL3 protein that is known to increase triglyceride levels in the blood. In some clinical trials, investigational medications that block the ANGPTL3 protein have been associated with decreases in triglyceride levels.
What are triglycerides and why do they matter?
Lowering the levels of triglycerides in the blood can reduce the risk of developing pancreatitis and may help prevent future heart attacks and strokes.
Some people have triglyceride levels that remain higher than their medically recommended goal, even after making lifestyle changes and taking currently available triglyceride-lowering medications (such as fibrates, omega-3 fatty acids or niacin). These individuals are at higher risk of pancreatitis, heart attack, or stroke compared with people who achieve their goal.
What are triglycerides and why do they matter?
Lowering the levels of triglycerides in the blood can reduce the risk of developing pancreatitis and may help prevent future heart attacks and strokes.
Some people have triglyceride levels that remain higher than their medically recommended goal, even after making lifestyle changes and taking currently available triglyceride-lowering medications (such as fibrates, omega-3 fatty acids or niacin). These individuals are at higher risk of pancreatitis, heart attack, or stroke compared with people who achieve their goal.
Why might you participate
By taking part in the Pulse-1 study, you will be contributing to the development of a potential new medicine that may help you and other people with high triglyceride levels in the future. Study participants will receive VERVE-201, which may help lower triglyceride levels for many years, possibly permanently, after a single dose. However, it is important to note that the safety and effectiveness of the investigational medicine on reducing triglyceride levels has not been
proven.
What to expect when participating in the Pulse-1 study
Participant qualifications
See if you prequalify
To prescreen for the Pulse-1 high LDL-C study, click here.
Your information is stored in a HIPAA-compliant database and provided to the trial sites for follow-up as appropriate. For further information, please see our privacy policy page.
See if you prequalify
To prescreen for the Pulse-1 high LDL-C study, click here.
The Pulse-1 study has three periods:
-
1
Screening period
(up to three months)
You will attend screening appointments to determine your eligibility for the Pulse-1 study. Several tests will be performed during this time, including taking blood samples and performing physical examinations.
- You will visit the study site twice to determine if you are eligible and whether the study is right for you. If you are eligible, you will have the option to join the study.
- The screening visits need to occur within a three-month time period.
-
2
Study treatment period
(up to four days)
If you qualify and decide to participate, the study treatment period will involve a stay of up to four days/three nights at the study site, during which:
- You will receive a single dose of VERVE-201 as an intravenous (IV) infusion into a vein in your arm.
- During your stay at the study center, the study team will monitor your health and conduct assessments similar to those in the screening period to check how well you tolerate VERVE-201.
-
3
Follow-up period
(about one year)
- There will be up to 11 follow-up visits over one year after receiving VERVE-201 to continue to monitor your health, including an end-of-study visit.
- After the end-of-study visit, you will take part in a separate long-term follow-up study where your health and lipid levels will continue to be monitored. Some of these visits can be done from home or your local primary care physician's office.