Recruiting
Phase 2

MAR001

Sponsor:

Marea Therapeutics

Code:

NCT07028749

Conditions

Hypertriglyceridemia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

MAR001

Placebo

Study Details

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.

Conditions

Hypertriglyceridemia

Study ID

NCT07028749

Start date

Jun 30, 2025

Status verified date

Sep, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

316 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MAR001 Dose 1 (Part A)

Subcutaneous injection

experimental: MAR001 Dose 2 (Part A)

Subcutaneous Injection

experimental: MAR001 Dose 3 (Part A)

Subcutaneous Injection

experimental: MAR001 Dose 4 (Part B)

Subcutaneous Injection

Interventions

MAR001

Subcutaneous Injection

Placebo

Subcutaneous injection

Primary outcome measure

  • Primary Endpoint [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Matty Hughes

415-766-3610TYDAL_info@mareatx.com

Locations

Marea Site 302

Recruiting

Boca Raton, Florida, United States, 33434

Marea Site 307

Recruiting

Port Saint Lucie, Florida, United States, 34952

Marea Site 319

Recruiting

Peachtree Corners, Georgia, United States, 30092

Marea Site 325

Recruiting

Springfield, Illinois, United States, 62702

Marea Site 305

Recruiting

St Louis, Missouri, United States, 63110

Marea Site 320

Recruiting

Little River, South Carolina, United States, 29566

Marea Site 326

Recruiting

Memphis, Tennessee, United States, 38119

Marea Site 406

Recruiting

Concord, Ontario, Canada, L4K 4M2

Marea Site 404

Recruiting

Sarnia, Ontario, Canada, N7T 4X3

Marea Site 401

Recruiting

Chicoutimi, Quebec, Canada, G7H 7K9

Marea Site 402

Recruiting

Montreal, Quebec, Canada, H1T 1C8

Marea Site 405

Recruiting

Québec, Quebec, Canada, G1G 3Y8

Marea Site 407

Recruiting

Québec, Quebec, Canada, G1V 4M6

More Information

Sponsor

Marea Therapeutics

Last update posted

Sep 2, 2026

Last verified

Sep, 2026

Keywords

  • Hypertriglyceridemia
  • MAR001
  • Remnant Cholesterol
  • TYDAL
  • TIMI-78

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Marea Therapeutics on 2026-09-02.