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NCT07028749PHASE2Recruiting

Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol

Marea Therapeutics

Start Date

6/30/2025

Completion Date

4/1/2028

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.

Detailed Description

MAR-103 is a randomized, double-blind, parallel-group, placebo-controlled study with two parts (Part A and Part B). In both Part A and Part B, participants will be randomized at Day 1. The study will include a screening period (up to 8 weeks), a 24-week treatment period, and a 12-week safety follow-up period. The 12-week safety follow-up period will include 2 clinic visits at Week 28 and Week 36 (End of Study). Part A: Approximately 216 participants with baseline TG between 150 to 880 mg/dL will be enrolled in Part A at a 3:1 ratio of MAR001 to placebo for dosing every 4 weeks (Q4W). Three doses of MAR001 will be administered. Part B: Approximately 100 participants with baseline TG between 450 and 2000 mg/dL will be enrolled in Part B at a 1:1 ratio of MAR001 to placebo for dosing every 4 weeks (Q4W). The MAR001 dose will be within the range tested during Part A and will be selected based on emerging Part A data.

Eligibility Criteria

Age Range: 18 years to 75 years

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

Interventions

DRUG

MAR001

DRUG

Placebo

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Conditions

Hypertriglyceridemia

Locations

Marea Site 328

Anniston, Alabama 36207

United States

Marea Site 329

Mobile, Alabama 36608

United States

Marea Site 313

Little Rock, Arkansas 72204

United States

Marea Site 306

Hamden, Connecticut 06517

United States

Marea Site 302

Boca Raton, Florida 33434

United States

Marea Site 307

Port Saint Lucie, Florida 34952

United States

Marea Site 310

Columbus, Georgia 31904

United States

Marea Site 319

Peachtree Corners, Georgia 30092

United States

Marea Site 317

Park Ridge, Illinois 60068

United States

Marea Site 325

Springfield, Illinois 62702

United States

Marea Site 301

Louisville, Kentucky 40213

United States

Marea Site 316

Baltimore, Maryland 21229

United States

Marea Site 330

Kansas City, Missouri 64151

United States

Marea Site 305

St Louis, Missouri 63110

United States

Marea Site 304

Great Neck, New York 11021

United States

Marea Site 318

New Windsor, New York 12553

United States

Marea Site 303

Greensboro, North Carolina 27405

United States

Marea Site 315

Winston-Salem, North Carolina 27104

United States

Marea Site 314

Greenville, South Carolina 29607

United States

Marea Site 320

Little River, South Carolina 29566

United States

Marea Site 326

Memphis, Tennessee 38119

United States

Marea Site 322

Amarillo, Texas 79124

United States

Marea Site 308

McKinney, Texas 75071

United States

Marea Site 312

San Antonio, Texas 78229

United States

Marea Site 321

Manassas, Virginia 20109

United States

Marea Site 309

Tacoma, Washington 98405

United States

Marea Site 103

Canberra, Australian Capital Territory 2617

Australia

Marea Site 105

Kanwal, New South Wales 2259

Australia

Marea Site 107

Merewether, New South Wales 2291

Australia

Marea Site 106

Miranda, New South Wales 2228

Australia

Marea Site 109

Wollongong, New South Wales 2500

Australia

Marea Site 108

Herston, Queensland 4006

Australia

Marea Site 104

Milton, Queensland 4064

Australia

Marea Site 111

Leabrook, South Australia 5068

Australia

Marea Site 102

Clayton, Victoria 3168

Australia

Marea Site 110

Heidelberg Heights, Victoria 3081

Australia

Marea Site 113

Hoppers Crossing, Victoria 3029

Australia

Marea Site 101

Nedlands, Western Australia 6009

Australia

Marea Site 112

Perth, Western Australia 6000

Australia

Marea Site 406

Concord, Ontario L4K 4M2

Canada

Marea Site 403

London, Ontario N5W6A2

Canada

Marea Site 404

Sarnia, Ontario N7T 4X3

Canada

Marea Site 401

Chicoutimi, Quebec G7H 7K9

Canada

Marea Site 402

Montreal, Quebec H1T 1C8

Canada

Marea Site 405

Québec, Quebec G1G 3Y8

Canada

Marea Site 407

Québec, Quebec G1V 4M6

Canada

Marea Site 211

Birkenhead, Auckland 0626

New Zealand

Marea Site 207

New Lynn, Auckland 0600

New Zealand

Marea Site 203

Papatoetoe, Auckland 2025

New Zealand

Marea Site 205

Silverdale, Auckland 0932

New Zealand

Marea Site 206

Christchurch, South Island 8013

New Zealand

Marea Site 204

Ebdentown, Upper Hutt 5018

New Zealand

Marea Site 209

Christchurch, 4710

New Zealand

Marea Site 202

Christchurch,

New Zealand

Marea Site 208

Rotorua, 3010

New Zealand