MAR001 for High Triglycerides
(TYDAL-TIMI 78 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called MAR001 for individuals with high triglycerides, which are fats found in the blood. The goal is to determine how effectively MAR001 lowers triglyceride and remnant cholesterol levels compared to a placebo (a substance with no active drug). Participants will receive one of three different doses of MAR001 through an injection under the skin. Suitable candidates have high triglycerides and remnant cholesterol, maintain a stable diet, and can continue with their current medications. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires that you stay on a stable drug regimen, so you should not change your current medications during the study.
Is there any evidence suggesting that MAR001 is likely to be safe for humans?
Earlier studies found MAR001 to be safe and generally well-tolerated. Researchers identified no serious side effects from the treatment. Participants showed no signs of swelling, irritation, or other concerning changes in the body. This suggests that MAR001 could be a safe option for individuals with high triglycerides, a type of fat in the blood.12345
Why are researchers excited about this trial's treatments?
Unlike the standard treatments for high triglycerides, which often rely on oral medications like statins or fibrates, MAR001 is administered via subcutaneous injection. Researchers are excited about MAR001 because it potentially offers a new mechanism of action, targeting triglyceride levels more directly and efficiently. The unique delivery method of MAR001 might also provide more consistent dosing and better patient compliance compared to daily pills. This innovative approach has the potential to significantly improve outcomes for patients struggling to manage their triglyceride levels.
What evidence suggests that MAR001 might be an effective treatment for high triglycerides?
Research has shown that MAR001 is promising in lowering high levels of triglycerides (a type of fat in the blood) and remnant cholesterol (leftover cholesterol in the blood after the body uses what it needs). In earlier studies, MAR001 reduced triglycerides by more than 50% compared to a placebo, and similar reductions in remnant cholesterol levels were observed. This suggests that MAR001 could help people with high triglycerides and remnant cholesterol. The treatment blocks a protein called ANGPTL4, which plays a role in how the body processes fat. Participants in this trial will receive one of three different doses of MAR001 to evaluate its effectiveness and safety.12346
Are You a Good Fit for This Trial?
This trial is for adults with high levels of triglycerides and remnant cholesterol who have been on a stable diet and medication regimen, with LDL-C levels within specific limits. They must be willing to follow the study's procedures and not have liver disease, extremely high triglycerides, type 1 diabetes, uncontrolled hypothyroidism, or active hepatitis.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive MAR001 or placebo via subcutaneous injection to evaluate the effect on triglycerides and remnant cholesterol levels
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MAR001
Find a Clinic Near You
Who Is Running the Clinical Trial?
Marea Therapeutics
Lead Sponsor
The TIMI Study Group
Collaborator