MAR001 for High Triglycerides

(TYDAL-TIMI 78 Trial)

Recruiting at 53 trial locations

Overseen By Andrew Lane

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Marea Therapeutics

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

216 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 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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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

Elevated nonfasting TGs and RC

Stable diet for a minimum of 3 months prior to screening and with no plans to change diet through duration of study

Elevated fasting TGs and RC

Exclusion Criteria

Any condition that prevents the participant from complying with study procedures

I have liver disease.

TG concentration ≥880mg/dl

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 evaluate the effect on triglycerides and remnant cholesterol levels

12 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 study tests MAR001 against a placebo to see its effects on lowering nonfasting and fasting triglyceride (TG) and remnant cholesterol (RC) levels in adults. Participants will randomly receive either MAR001 or a placebo to compare outcomes.

How Is the Trial Designed?

Group I: MAR001 Dose 3 Experimental Treatment 2 Interventions

Subcutaneous Injection

Group II: MAR001 Dose 2 Experimental Treatment 2 Interventions

Subcutaneous Injection

Group III: MAR001 Dose 1 Experimental Treatment 2 Interventions

Subcutaneous injection

Who Is Running the Clinical Trial?

Marea Therapeutics

Lead Sponsor

Trials

1

Recruited

60+

The TIMI Study Group

Collaborator

Trials

22

Recruited

129,000+

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 ...