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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Willingness to provide willing to sign a consent form 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 Who Should NOT Join This Trial: - 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 weakened immune system virus (HIV) infection - Uncontrolled hypothyroidism - Any condition that prevents the participant from complying with study procedures Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

MAR001

Subcutaneous Injection

DRUG

Placebo

Subcutaneous Injection

Locations (1)

Marea Site 301
Chula Vista, California, United States