MAR001 for adults with high triglycerides and remnant cholesterol
Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of MAR001 on Postprandial Lipids in Patients With Elevated Triglycerides and Remnant Cholesterol
This trial will try the drug MAR001 to lower post-meal triglycerides and remnant cholesterol in adults with elevated triglyceride levels.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Marea Therapeutics Industry-sponsored |
| Locations | 1 site (Chula Vista, California) |
| Trial ID | NCT07199309 on ClinicalTrials.gov |
What this trial studies
This is a Phase 2 mechanistic interventional trial comparing MAR001 with placebo to measure changes in postprandial triglycerides in adults who have elevated fasting triglycerides. Eligible participants must have two fasting triglyceride measurements at screening, an HbA1c between 5.7% and 8.5%, and stable diet and medication regimens. Key exclusions include acute or chronic liver disease, uncontrolled HIV, active viral hepatitis, type 1 diabetes, recent diabetic ketoacidosis, and use of diabetes medications other than metformin. The study is conducted at a single Marea Therapeutics site in Chula Vista, California, and focuses on laboratory measures of triglycerides and remnant cholesterol following a standardized challenge.
Who should consider this trial
Good fit: Adults with elevated fasting triglycerides who can maintain a stable diet and medication regimen, meet screening labs including HbA1c 5.7–8.5%, and are able to attend the Chula Vista site are ideal candidates.
Not a fit: Patients with active liver disease, uncontrolled HIV, type 1 diabetes or recent diabetic ketoacidosis, or those using diabetes drugs other than metformin are unlikely to benefit or be eligible for this protocol.
Why it matters
Potential benefit: If successful, MAR001 could lower post-meal triglyceride and remnant cholesterol levels and potentially reduce cardiovascular risk in people with high triglycerides.
How similar studies have performed: While lowering triglycerides and remnant cholesterol has been achieved with agents like fibrates and high-dose omega-3s, MAR001 is a novel agent with limited published human data to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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% * Stable diet for a minimum of 3 months prior to screening and with no plans to change diet through duration of study * Stable drug regimen (appropriate if relevant) prior to screening visit and no planned changes during screening or trial participation Exclusion Criteria: * Acute or chronic liver disease * Diabetes medications (other than metformin) * History of type 1 diabetes mellitus or history of diabetic ketoacidosis * Newly diagnosed T2DM * Participants with known active hepatitis A, B, or C * Participants who are known to have uncontrolled human immunodeficiency virus (HIV) infection * Uncontrolled hypothyroidism * Any condition that prevents the participant from complying with study procedures
Where this trial is running
Chula Vista, California
- Marea Site 301 — Chula Vista, California, United States (Recruiting)
Study contacts
- Study coordinator: Andrew Lane
- Email: MAR-104-info@mareatx.com
- Phone: 415-766-3610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.