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NCT Number: NCT07199309

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

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.

Recruiting

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Key information

Conditions

Hypertriglyceridemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Marea Site 301

Chula Vista, California, 91911, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MAR001

Drug

Subcutaneous Injection

Placebo

Drug

Subcutaneous Injection

Primary outcomes

  1. Change from baseline in TG area under the curve after a mixed meal

    Time frame: 12 weeks

  2. Change from baseline in peak plasma TG concentration after a mixed meal

    Time frame: 12 weeks

Secondary outcomes

  1. Change from baseline in RC area under the curve after a mixed meal

    Time frame: 12 weeks

  2. Change from baseline in peak plasma RC concentration after a mixed meal

    Time frame: 12 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Lane

CONTACT

[email protected]

415-766-3610

Sponsors and collaborators

Lead sponsor

Marea Therapeutics

Industry

Registry information

Official study title

Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of MAR001 on Postprandial Lipids in Patients With Elevated Triglycerides and Remnant Cholesterol

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 30, 2025
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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