NCT07028749 · Marea Therapeutics
Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol
(TYDAL-TIMI 78)
What this study is about
The primary objective of the study is to evaluate the effect of MAR001 compared to placebo on levels of the TG and RC in adults with elevated TG and RC.
View original scientific description
The primary objective of the study is to evaluate the effect of MAR001 compared to placebo on levels of the TG and RC in adults with elevated TG and RC.
Interventions
DRUG
MAR001
Subcutaneous Injection
DRUG
Placebo
Subcutaneous injection
Primary outcome measures
Primary Endpoint
Time frame: 12 weeks
Percent change from baseline at Week 12 in fasting TG compared to placebo
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 diet through duration of study
- 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
Where
- Anniston, Alabama
- Mobile, Alabama
- Little Rock, Arkansas
- Hamden, Connecticut
- Boca Raton, Florida
- Port Saint Lucie, Florida
- Columbus, Georgia
- Peachtree Corners, Georgia
- Park Ridge, Illinois
- Springfield, Illinois
- Louisville, Kentucky
- Baltimore, Maryland
And 14 more locations — see the full list below.
Collaborators
The TIMI Study Group
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations