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)
View Full Details on ClinicalTrials.gov
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NCT07199309
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