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

NCT ID: NCT07199309

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-26

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertriglyceridemia

Keywords

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Remnant Cholesterol MAR001 Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MAR001 Dose

Subcutaneous Injection

Group Type EXPERIMENTAL

MAR001

Intervention Type DRUG

Subcutaneous Injection

Matching Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneous Injection

Interventions

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MAR001

Subcutaneous Injection

Intervention Type DRUG

Placebo

Subcutaneous Injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marea Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Marea Site 301

Chula Vista, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Andrew Lane

Role: CONTACT

Phone: 415-766-3610

Email: [email protected]

Other Identifiers

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MAR-104

Identifier Type: -

Identifier Source: org_study_id