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Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol
RecruitingPhase 2
Phase 2b Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of MAR001 in Patients With Elevated Triglycerides and Remnant Cholesterol (TYDAL-TIMI 78)
Who can join
Ages 18 to 75 · All sexes
Full 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 proceduresAbout the study
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.
What is being tested
- MAR001 (drug)
- Placebo (drug)
Sponsor: Marea Therapeutics · Participants: 316 · Started: Jun 30, 2025
Contact the study team
- Matty Hughes · Phone: 415-766-3610
Official record on ClinicalTrials.gov — NCT07028749
Locations in the U.S.
| Florida | Marea Site 302, Boca Raton Marea Site 307, Port Saint Lucie |
| Georgia | Marea Site 319, Peachtree Corners |
| Illinois | Marea Site 325, Springfield |
| Missouri | Marea Site 305, St Louis |
| South Carolina | Marea Site 320, Little River |
| Tennessee | Marea Site 326, Memphis |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.