Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol

NCT07028749 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MAR-103
• Study Type: interventional
• Target: 316
• Locations: 4 countries
• Sites: 55

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

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

  12 weeks

Secondary Outcomes (4)

• Secondary Endpoint

  12 weeks

• Secondary Endpoint

  12 weeks

• Secondary Endpoint

  16 weeks

• Secondary Endpoint

  12 weeks

Study Arms (4)

MAR001 Dose 1 (Part A)

EXPERIMENTAL

Subcutaneous injection

Drug: MAR001; Drug: Placebo

MAR001 Dose 2 (Part A)

EXPERIMENTAL

Subcutaneous Injection

Drug: MAR001; Drug: Placebo

MAR001 Dose 3 (Part A)

EXPERIMENTAL

Subcutaneous Injection

Drug: MAR001; Drug: Placebo

MAR001 Dose 4 (Part B)

EXPERIMENTAL

Subcutaneous Injection

Drug: MAR001; Drug: Placebo

Interventions

Placebo DRUG

Subcutaneous injection

MAR001 Dose 1 (Part A); MAR001 Dose 2 (Part A); MAR001 Dose 3 (Part A); MAR001 Dose 4 (Part B)

MAR001 DRUG

Subcutaneous Injection

MAR001 Dose 1 (Part A); MAR001 Dose 2 (Part A); MAR001 Dose 3 (Part A); MAR001 Dose 4 (Part B)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marea Therapeutics: lead
• The TIMI Study Group: collaborator

Study Sites (55)

Marea Site 328

Anniston, Alabama, 36207, United States

ACTIVE NOT RECRUITING

Marea Site 329

Mobile, Alabama, 36608, United States

ACTIVE NOT RECRUITING

Marea Site 313

Little Rock, Arkansas, 72204, United States

ACTIVE NOT RECRUITING

Marea Site 306

Hamden, Connecticut, 06517, United States

ACTIVE NOT RECRUITING

Marea Site 302

Boca Raton, Florida, 33434, United States

RECRUITING

Marea Site 307

Port Saint Lucie, Florida, 34952, United States

RECRUITING

Marea Site 310

Columbus, Georgia, 31904, United States

ACTIVE NOT RECRUITING

Marea Site 319

Peachtree Corners, Georgia, 30092, United States

RECRUITING

Marea Site 317

Park Ridge, Illinois, 60068, United States

ACTIVE NOT RECRUITING

Marea Site 325

Springfield, Illinois, 62702, United States

RECRUITING

Marea Site 301

Louisville, Kentucky, 40213, United States

ACTIVE NOT RECRUITING

Marea Site 316

Baltimore, Maryland, 21229, United States

ACTIVE NOT RECRUITING

Marea Site 330

Kansas City, Missouri, 64151, United States

ACTIVE NOT RECRUITING

Marea Site 305

St Louis, Missouri, 63110, United States

RECRUITING

Marea Site 304

Great Neck, New York, 11021, United States

ACTIVE NOT RECRUITING

Marea Site 318

New Windsor, New York, 12553, United States

ACTIVE NOT RECRUITING

Marea Site 303

Greensboro, North Carolina, 27405, United States

ACTIVE NOT RECRUITING

Marea Site 315

Winston-Salem, North Carolina, 27104, United States

ACTIVE NOT RECRUITING

Marea Site 314

Greenville, South Carolina, 29607, United States

ACTIVE NOT RECRUITING

Marea Site 320

Little River, South Carolina, 29566, United States

RECRUITING

Marea Site 326

Memphis, Tennessee, 38119, United States

RECRUITING

Marea Site 322

Amarillo, Texas, 79124, United States

ACTIVE NOT RECRUITING

Marea Site 308

McKinney, Texas, 75071, United States

ACTIVE NOT RECRUITING

Marea Site 312

San Antonio, Texas, 78229, United States

ACTIVE NOT RECRUITING

Marea Site 321

Manassas, Virginia, 20109, United States

ACTIVE NOT RECRUITING

Marea Site 309

Tacoma, Washington, 98405, United States

ACTIVE NOT RECRUITING

Marea Site 103

Canberra, Australian Capital Territory, 2617, Australia

ACTIVE NOT RECRUITING

Marea Site 105

Kanwal, New South Wales, 2259, Australia

ACTIVE NOT RECRUITING

Marea Site 107

Merewether, New South Wales, 2291, Australia

ACTIVE NOT RECRUITING

Marea Site 106

Miranda, New South Wales, 2228, Australia

ACTIVE NOT RECRUITING

Marea Site 109

Wollongong, New South Wales, 2500, Australia

ACTIVE NOT RECRUITING

Marea Site 108

Herston, Queensland, 4006, Australia

ACTIVE NOT RECRUITING

Marea Site 104

Milton, Queensland, 4064, Australia

RECRUITING

Marea Site 111

Leabrook, South Australia, 5068, Australia

RECRUITING

Marea Site 102

Clayton, Victoria, 3168, Australia

RECRUITING

Marea Site 110

Heidelberg Heights, Victoria, 3081, Australia

ACTIVE NOT RECRUITING

Marea Site 113

Hoppers Crossing, Victoria, 3029, Australia

ACTIVE NOT RECRUITING

Marea Site 101

Nedlands, Western Australia, 6009, Australia

RECRUITING

Marea Site 112

Perth, Western Australia, 6000, Australia

RECRUITING

Marea Site 406

Concord, Ontario, L4K 4M2, Canada

RECRUITING

Marea Site 403

London, Ontario, N5W6A2, Canada

ACTIVE NOT RECRUITING

Marea Site 404

Sarnia, Ontario, N7T 4X3, Canada

RECRUITING

Marea Site 401

Chicoutimi, Quebec, G7H 7K9, Canada

RECRUITING

Marea Site 402

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

Marea Site 405

Québec, Quebec, G1G 3Y8, Canada

RECRUITING

Marea Site 407

Québec, Quebec, G1V 4M6, Canada

RECRUITING

Marea Site 211

Birkenhead, Auckland, 0626, New Zealand

RECRUITING

Marea Site 207

New Lynn, Auckland, 0600, New Zealand

ACTIVE NOT RECRUITING

Marea Site 203

Papatoetoe, Auckland, 2025, New Zealand

ACTIVE NOT RECRUITING

Marea Site 205

Silverdale, Auckland, 0932, New Zealand

RECRUITING

Marea Site 206

Christchurch, South Island, 8013, New Zealand

RECRUITING

Marea Site 204

Ebdentown, Upper Hutt, 5018, New Zealand

ACTIVE NOT RECRUITING

Marea Site 209

Christchurch, 4710, New Zealand

ACTIVE NOT RECRUITING

Marea Site 202

Christchurch, New Zealand

ACTIVE NOT RECRUITING

Marea Site 208

Rotorua, 3010, New Zealand

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Matty Hughes

CONTACT

415-766-3610; TYDAL_info@mareatx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: September 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (26); AU (13); CA (7); NZ (9)