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

Marea Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Hypertriglyceridemia

Treatments: Drug: MAR001; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07199309

MAR-104

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

MAR001 Dose

Experimental group

Description:

Subcutaneous Injection

Treatment:

Drug: MAR001

Matching Placebo

Placebo Comparator group

Treatment:

Drug: Placebo