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Active, Not Recruiting

NCT Number: NCT07028749

Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol

The primary objective of the study is to evaluate the effect of MAR001 compared to placebo on levels of TG in adults with elevated TG and RC.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hypertriglyceridemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Marea Site 103, Canberra, Australian Capital Territory, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elevated fasting TGs and RC
  • Elevated nonfasting TGs and RC
  • Fasting LDL-C ≥ 50 mg/dL (≥ 1.29 mmol/L) and ≤ 130 mg/dL (≤ 3.36 mmol/L)
  • Willingness to provide informed consent and comply with the intervention and all study assessments
  • Stable diet for a minimum of 3 months prior to screening and with no plans to change during screening or trial participation
  • Stable drug regimen (if relevant) prior to screening visit and no planned changes during screening or trial participation

Exclusion criteria

  • Acute or chronic liver disease
  • TG concentration ≥880mg/dl
  • History of type 1 diabetes mellitus or history of diabetic ketoacidosis
  • Newly diagnosed T2DM
  • Participants with known active hepatitis A, B, or C
  • Uncontrolled hypothyroidism
  • Any condition that prevents the participant from complying with study procedures

Treatment and study plan

MAR001

Drug

Subcutaneous Injection

Placebo

Drug

Subcutaneous injection

Primary outcomes

  1. Primary Endpoint

    Time frame: 12 weeks

    Percent change from baseline in fasting TG compared to placebo

Secondary outcomes

  1. Secondary Endpoint

    Time frame: 12 weeks

    Proportion of participants with baseline TG ≥150 mg/dL achieving TG <150 mg/dL compared to placebo

  2. Secondary Endpoint

    Time frame: 12 weeks

    Percent change from baseline in fasting RC compared to placebo

  3. Secondary Endpoint

    Time frame: 16 weeks

    Percent change from baseline in non-fasting TG compared to placebo

  4. Secondary Endpoint

    Time frame: 12 weeks

    Percent change from baseline in fasting TG compared to placebo in participants with baseline TG ≥300 mg/dL

Sponsors and collaborators

Lead sponsor

Marea Therapeutics

Industry

Collaborators

  • The TIMI Study Group

Registry information

Official study title

Phase 2b Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of MAR001 in Patients With Elevated Triglycerides and Remnant Cholesterol (TYDAL-TIMI 78)

Acronym: TYDAL-TIMI 78

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 19, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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