Actively Recruiting
Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of MAR001 on Postprandial Lipids in Patients With Elevated 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
Eligibility Criteria
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive subcutaneous injections of MAR001 or placebo as part of the study intervention.
Trial Site Locations
Total: 1 location
1
Marea Site 301
Chula Vista, California, United States, 91911
Actively Recruiting
Research Team
A
Andrew Lane
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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