NCT07028749 Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol
| NCT ID | NCT07028749 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Marea Therapeutics |
| Condition | Hypertriglyceridemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 316 participants |
| Start Date | 2025-06-30 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 316 participants in total. It began in 2025-06-30 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07028749 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Hypertriglyceridemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07028749 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07028749 currently recruiting?
Yes, NCT07028749 is actively recruiting participants. Contact the research team at TYDAL_info@mareatx.com for enrollment information.
Where is the NCT07028749 trial being conducted?
This trial is being conducted at Anniston, United States, Mobile, United States, Little Rock, United States, Hamden, United States and 11 additional locations.
Who is sponsoring the NCT07028749 clinical trial?
NCT07028749 is sponsored by Marea Therapeutics. The trial plans to enroll 316 participants.