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Recruiting NCT07199309

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

Phase II Interventional Hypertriglyceridemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MAR001, Placebo.
Who it may be relevant to
Registry conditions: Hypertriglyceridemia. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of MAR001 on Postprandial Lipids in Patients With Elevated Triglycerides and Remnant Cholesterol

Overview

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.

Interventions

  • Drug MAR001
    Subcutaneous Injection
  • Drug Placebo
    Subcutaneous Injection

Primary outcome measures

  • Change from baseline in TG area under the curve after a mixed meal [Time frame: 12 weeks]
  • Change from baseline in peak plasma TG concentration after a mixed meal [Time frame: 12 weeks]
Secondary outcome measures (2)
  • Change from baseline in RC area under the curve after a mixed meal [Time frame: 12 weeks]
  • Change from baseline in peak plasma RC concentration after a mixed meal [Time frame: 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Marea Site 301 — Chula Vista

Identifiers

NCT: NCT07199309 · MAR-104

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗