Lomitapide for Hypercholesterolemia
(LOWER Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on the long-term safety and effectiveness of the medication lomitapide, which helps manage cholesterol levels. The study seeks individuals who have already incorporated lomitapide into their regular treatment plan. Participants must understand the study requirements and agree to share their health information. This trial excludes individuals taking other experimental medications concurrently. As a Phase 4 trial, this research aims to understand how this FDA-approved and proven effective treatment benefits a broader range of patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be on any investigational drugs (new drugs not yet approved) when you start lomitapide.
What is the safety track record for lomitapide?
Research shows that lomitapide is usually well-tolerated, but it can cause some side effects. Common issues include digestive problems such as diarrhea, nausea, and an upset stomach. Some individuals might also experience back pain or constipation. More serious concerns involve liver problems, so doctors need to monitor liver health with blood tests for those taking lomitapide. Although these side effects might sound concerning, understanding them can aid in management. Prospective trial participants should discuss these possible effects with their doctor.12345
Why are researchers excited about this trial?
Lomitapide is unique because it works by directly inhibiting the microsomal triglyceride transfer protein (MTP), which plays a crucial role in the production of low-density lipoprotein (LDL) cholesterol. Unlike standard treatments for high cholesterol, which often include statins or PCSK9 inhibitors, lomitapide offers a different approach by targeting the production of cholesterol at its source. Researchers are excited about lomitapide because it provides an alternative for patients who might not respond well to existing therapies or who have specific conditions like homozygous familial hypercholesterolemia, where traditional treatments might not be as effective.
What evidence suggests that lomitapide might be an effective treatment for long-term safety and effectiveness?
Research has shown that lomitapide, the treatment under study in this trial, effectively lowers bad cholesterol levels. In one study, patients experienced a reduction of about 53.5% after 24 weeks. Another study found a 50% reduction at the end of 78 weeks. Long-term data indicate that some patients had a reduction of nearly 60% over nine years. Notably, many patients reached healthy cholesterol levels, suggesting that lomitapide can significantly help manage high cholesterol.678910
Who Is on the Research Team?
Janet Boylan
Principal Investigator
Amryt Pharmaceuticals
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive lomitapide as prescribed by their physician
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lomitapide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amryt Pharma
Lead Sponsor