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Recruiting Phase 2

A Mechanistic Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol

NCT07199309 · tracked via the Priya Life Science USA tracker
Phase
Phase 2
Started
2025-09-26
Last updated
2025-11-06

Condition(s) studied

Hypertriglyceridemia

Investigational drug(s) / intervention(s)

MAR001 →Placebo

MAR001: Subcutaneous Injection

Placebo: Subcutaneous Injection

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Marea Site 301 Chula Vista California Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07199309 on ClinicalTrials.gov ↗ ← All trials in the USA