MAR001 for High Triglycerides

Overseen By Andrew Lane

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Marea Therapeutics

Must not be taking: Diabetes medications

Disqualifiers: Liver disease, Type 1 diabetes, Hepatitis, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MAR001, a potential drug, to determine if it can lower triglyceride levels (a type of fat in the blood) after meals in people with high triglycerides. Participants will receive either the MAR001 treatment or a placebo (a substance with no active ingredients) for comparison. The trial seeks adults with stable triglyceride levels from past tests who follow a consistent diet but still have high triglycerides. 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 your current medication regimen without changes during the study.

Is there any evidence suggesting that MAR001 is likely to be safe for humans?

Research has shown that MAR001 is generally safe for people. Studies indicate that most individuals can take it without serious issues. No signs of treatment-related inflammation or unexpected bodily changes appeared. In both single and repeated doses over 12 weeks, MAR001 did not cause significant side effects. This suggests that MAR001 is safe for most people, based on past research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional treatments for high triglycerides, which often involve oral medications like statins or fibrates, MAR001 is unique because it's administered through a subcutaneous injection. This method could potentially offer a more direct and efficient way of lowering triglyceride levels. Researchers are excited about MAR001 because it may provide a new mechanism of action, possibly targeting triglycerides in a way that current oral medications do not. This innovative approach could lead to more effective management of high triglycerides with potentially fewer side effects.

What evidence suggests that MAR001 might be an effective treatment for high triglycerides?

Research has shown that MAR001, the investigational treatment in this trial, can significantly lower triglycerides, fats in the blood that can lead to heart problems. MAR001 blocks a protein called ANGPTL4, which helps reduce these fats. In one study, participants taking MAR001 experienced a 52.7% decrease in triglycerides compared to those taking a placebo, indicating its potential effectiveness in lowering high triglyceride levels. Additionally, MAR001 reduced remnant cholesterol, another heart disease risk factor, by over 50%. These findings suggest MAR001 might be a promising treatment for people with high triglycerides. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Adults with high triglycerides who are willing to follow the study's procedures can join. They must have stable diets and medications, no plans to change them during the trial, and HbA1c levels between 5.7% and 8.5%. People with uncontrolled HIV, liver diseases, certain diabetes conditions or medications (except metformin), or active hepatitis cannot participate.

Inclusion Criteria

Willingness to provide informed consent and comply with the intervention and all study assessments

Two fasting TG collected at two separate, consecutive visits at least 7 days apart during the Screening period

HbA1c ≥ 5.7% and ≤ 8.5%

Exclusion Criteria

Participants who are known to have uncontrolled human immunodeficiency virus (HIV) infection

Any condition that prevents the participant from complying with study procedures

I have liver disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MAR001 or placebo via subcutaneous injection to assess the effect on postprandial triglyceride levels

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MAR001

Trial Overview The trial is testing MAR001 against a placebo to see how it affects triglyceride levels after eating in adults with elevated triglycerides. Participants will be randomly assigned to receive either MAR001 or a placebo for comparison.

How Is the Trial Designed?

Group I: MAR001 Dose Experimental Treatment 1 Intervention

Subcutaneous Injection

Group II: Matching Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Marea Therapeutics

Lead Sponsor

Trials

1

Recruited

60+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07028749

Study of MAR001 in Adults With Elevated Triglycerides and ... Study Details | NCT07028749 | Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol | ClinicalTrials.gov.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40383129/

Safety and efficacy of a novel ANGPTL4 inhibitory antibody ... MAR001 (450 mg) yielded placebo-adjusted week 12 mean reductions in triglycerides of 52·7% (90% CI -77·0 to -28·3) and in remnant cholesterol of ...

3. mareatx.com mareatx.com/press-releases/marea-therapeutics-presents-positive-data-from-phase-2a-clinical-trial-of-mar001-being-developed-for-cardiovascular-disease-in-late-breaking-oral-session-at-the-93rd-eas-congress/

Marea Therapeutics Presents Positive Data from Phase 2a ... MAR001 demonstrated up to a 52.5% placebo-adjusted mean reduction in remnant cholesterol and up to a 52.7% placebo-adjusted mean reduction in ...

4. 2minutemedicine.com 2minutemedicine.com/novel-inhibitory-antibody-mar001-lowers-triglycerides-and-remnant-cholesterol-in-humans/

Novel inhibitory antibody, MAR001, lowers triglycerides ... According to study results, MAR001 reduced triglycerides and remnant cholesterol by over 50% compared to placebo. Although this study was well ...

5. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)00825-6/abstract

Safety and efficacy of a novel ANGPTL4 inhibitory antibody ... ANGPTL4 inhibition with MAR001 can safely and effectively reduce circulating triglycerides and remnant cholesterol. The findings of these trials ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0140673625008256

Safety and efficacy of a novel ANGPTL4 inhibitory antibody ... We found that single-dose and 12-week multidose administration of MAR001 was generally safe and well tolerated, and did not induce the symptoms ...