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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.

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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

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About this study

MAR-103 is a randomized, double-blind, parallel-group, placebo-controlled study with two parts (Part A and Part B).

In both Part A and Part B, participants will be randomized at Day 1. The study will include a screening period (up to 8 weeks), a 24-week treatment period, and a 12-week safety follow-up period. The 12-week safety follow-up period will include 2 clinic visits at Week 28 and Week 36 (End of Study).

Part A: Approximately 216 participants with baseline TG between 150 to 880 mg/dL will be enrolled in Part A at a 3:1 ratio of MAR001 to placebo for dosing every 4 weeks (Q4W). Three doses of MAR001 will be administered.

Part B: Approximately 100 participants with baseline TG between 450 and 2000 mg/dL will be enrolled in Part B at a 1:1 ratio of MAR001 to placebo for dosing every 4 weeks (Q4W). The MAR001 dose will be within the range tested during Part A and will be selected based on emerging Part A data.

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
  • Part A only: 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 after enrollment; Part B only: adjustment of lipid-lowering therapy during the diet/lifestyle run-in period is permitted

Exclusion criteria

  • Acute or chronic liver disease
  • Part A only: TG concentration ≥880mg/dl; Part B only: TG concentration ≥2000 mg/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
  • Part B only: recent history of active pancreatitis
  • Part B only: genetically confirmed Familial Chylomicronemia Syndrome (FCS) diagnosis due to biallelic loss of function mutations in LPL or GPIHBP1
  • Part B only: use of ANGPTL3 and ApoC-III inhibitors
  • 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 at Week 12 in fasting TG compared to placebo

Secondary outcomes

  1. Secondary Endpoint

    Time frame: 12 weeks

    Proportion of participants with

    Part A: baseline TG ≥150 mg/dL achieving TG <150 mg/dL at Week 12 compared to placebo

    Part B: baseline TG ≥500 mg/dL achieving TG <500 mg/dL at Week 12 compared to placebo

  2. Secondary Endpoint

    Time frame: 12 weeks

    Percent change from baseline at Week 12 in fasting RC compared to placebo

  3. Secondary Endpoint

    Time frame: 16 weeks

    Percent change from baseline at Week 16 in non-fasting TG compared to placebo

  4. Secondary Endpoint

    Time frame: 12 weeks

    Part A only: Percent change from baseline at Week 12 in fasting TG compared to placebo in participants with baseline TG ≥300 mg/dL

Study contacts

Contact information is provided by the study sponsor or research team.

Matty Hughes

CONTACT

[email protected]

415-766-3610

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
2027
Study completion
2028
First posted
Jun 19, 2025
Registry last updated
Aug 5, 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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