RecruitingPhase 2NCT07199309

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


Sponsor

Marea Therapeutics

Enrollment

30 participants

Start Date

Sep 26, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

  • 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 Criteria8

  • 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

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Interventions

DRUGMAR001

Subcutaneous Injection

DRUGPlacebo

Subcutaneous Injection


Locations(1)

Marea Site 301

Chula Vista, California, United States

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NCT07199309


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