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Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
ID07199309

Phase 2 Study of MAR001 Injection to Lower Post-Meal Triglycerides in Adults with High Triglycerides and Remnant Cholesterol

Led by Marea Therapeutics · Updated on 2025-11-06

30

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the effects of MAR001 on adults with high triglycerides and remnant cholesterol. This phase 2, randomized, double-blind, placebo-controlled trial aims to compare MAR001 with a placebo to see how it changes triglyceride levels after eating a mixed meal. The study focuses on the postprandial after eating state in adults aged 18 to 75 years with elevated triglycerides and remnant cholesterol. Participants receive either MAR001 or a matching placebo through subcutaneous injections. The treatment period lasts 12 weeks, during which researchers measure changes in triglycerides and remnant cholesterol levels after a mixed meal. The study uses a quadruple-blind design, meaning participants, care providers, investigators, and outcomes assessors do not know who receives MAR001 or placebo. During the study, participants will have fasting triglyceride tests at screening and regular assessments throughout the 12 weeks. Researchers will track the area under the curve and peak plasma concentrations of triglycerides and remnant cholesterol after meals to evaluate treatment effects. Participants must maintain stable diets and medication regimens during the trial. Safety and adherence will be monitored with ongoing assessments to understand the impact of MAR001 compared to placebo.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willingness to provide informed consent and comply with the intervention and all study assessments
  • Two fasting triglyceride measurements collected at two separate, consecutive visits at least 7 days apart during screening
  • HbA1c between 5.7% and 8.5%
  • Stable diet for at least 3 months before screening with no plans to change diet during the study
  • Stable drug regimen prior to screening and no planned changes during screening or trial participation
Not Eligible

You will not qualify if you...

  • Acute or chronic liver disease
  • Use of diabetes medications other than metformin
  • History of type 1 diabetes mellitus or diabetic ketoacidosis
  • Newly diagnosed type 2 diabetes mellitus
  • Known active hepatitis A, B, or C infection
  • Known uncontrolled human immunodeficiency virus (HIV) infection
  • Uncontrolled hypothyroidism
  • Any condition preventing compliance with study procedures

Research Team

A

Andrew Lane

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