A Mechanistic Study of MAR001 in Adults With Elevated 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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07199309

Enrollment

Registered

2025-09-30

Start date

2025-09-26

Completion date

2026-11-30

Last updated

2025-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia

Keywords

Remnant Cholesterol, MAR001, Hypertriglyceridemia

Brief summary

The primary objective of the study is to determine the effect of MAR001 as compared to placebo on levels of the triglycerides (TG) in the postprandial state in adults with elevated TG.

Interventions

DRUGMAR001

Subcutaneous Injection

DRUGPlacebo

Subcutaneous Injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in TG area under the curve after a mixed meal	12 weeks
Change from baseline in peak plasma TG concentration after a mixed meal	12 weeks

Secondary

Measure	Time frame
Change from baseline in RC area under the curve after a mixed meal	12 weeks
Change from baseline in peak plasma RC concentration after a mixed meal	12 weeks

Countries

United States

Contacts

Primary ContactAndrew Lane

MAR-104-info@mareatx.com415-766-3610

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026