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New drug MAR001 aims to tackle stubborn high triglycerides

NCT ID NCT07028749

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 03, 2026 · Updated 5 times

Summary

This Phase 2b study tests whether the experimental drug MAR001 can lower high triglycerides and remnant cholesterol in adults. About 216 participants will receive either MAR001 or a placebo by injection. The main goal is to see if MAR001 reduces triglyceride levels more than placebo over the study period.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MAR001
What this could lead to
If successful, MAR001 could offer a new treatment option to lower high triglycerides and remnant cholesterol, potentially reducing heart disease risk.
What could go wrong
This is an early Phase 2b trial with only 216 participants, so results may not confirm effectiveness or safety. The drug may not work better than placebo or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 316 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Marea Site 101

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Marea Site 102

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Marea Site 103

    ACTIVE_NOT_RECRUITING

    Canberra, Australian Capital Territory, 2617, Australia

  • Marea Site 104

    RECRUITING

    Milton, Queensland, 4064, Australia

  • Marea Site 105

    ACTIVE_NOT_RECRUITING

    Kanwal, New South Wales, 2259, Australia

  • Marea Site 106

    ACTIVE_NOT_RECRUITING

    Miranda, New South Wales, 2228, Australia

  • Marea Site 107

    ACTIVE_NOT_RECRUITING

    Merewether, New South Wales, 2291, Australia

  • Marea Site 108

    ACTIVE_NOT_RECRUITING

    Herston, Queensland, 4006, Australia

  • Marea Site 109

    ACTIVE_NOT_RECRUITING

    Wollongong, New South Wales, 2500, Australia

  • Marea Site 110

    ACTIVE_NOT_RECRUITING

    Heidelberg Heights, Victoria, 3081, Australia

  • Marea Site 111

    RECRUITING

    Leabrook, South Australia, 5068, Australia

  • Marea Site 112

    RECRUITING

    Perth, Western Australia, 6000, Australia

  • Marea Site 113

    ACTIVE_NOT_RECRUITING

    Hoppers Crossing, Victoria, 3029, Australia

  • Marea Site 202

    ACTIVE_NOT_RECRUITING

    Christchurch, New Zealand

  • Marea Site 203

    ACTIVE_NOT_RECRUITING

    Papatoetoe, Auckland, 2025, New Zealand

  • Marea Site 204

    ACTIVE_NOT_RECRUITING

    Ebdentown, Upper Hutt, 5018, New Zealand

  • Marea Site 205

    RECRUITING

    Silverdale, Auckland, 0932, New Zealand

  • Marea Site 206

    RECRUITING

    Christchurch, South Island, 8013, New Zealand

  • Marea Site 207

    ACTIVE_NOT_RECRUITING

    New Lynn, Auckland, 0600, New Zealand

  • Marea Site 208

    ACTIVE_NOT_RECRUITING

    Rotorua, 3010, New Zealand

  • Marea Site 209

    ACTIVE_NOT_RECRUITING

    Christchurch, 4710, New Zealand

  • Marea Site 211

    RECRUITING

    Birkenhead, Auckland, 0626, New Zealand

  • Marea Site 301

    ACTIVE_NOT_RECRUITING

    Louisville, Kentucky, 40213, United States

  • Marea Site 302

    RECRUITING

    Boca Raton, Florida, 33434, United States

  • Marea Site 303

    ACTIVE_NOT_RECRUITING

    Greensboro, North Carolina, 27405, United States

  • Marea Site 304

    ACTIVE_NOT_RECRUITING

    Great Neck, New York, 11021, United States

  • Marea Site 305

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Marea Site 306

    ACTIVE_NOT_RECRUITING

    Hamden, Connecticut, 06517, United States

  • Marea Site 307

    RECRUITING

    Port Saint Lucie, Florida, 34952, United States

  • Marea Site 308

    ACTIVE_NOT_RECRUITING

    McKinney, Texas, 75071, United States

  • Marea Site 309

    ACTIVE_NOT_RECRUITING

    Tacoma, Washington, 98405, United States

  • Marea Site 310

    ACTIVE_NOT_RECRUITING

    Columbus, Georgia, 31904, United States

  • Marea Site 312

    ACTIVE_NOT_RECRUITING

    San Antonio, Texas, 78229, United States

  • Marea Site 313

    ACTIVE_NOT_RECRUITING

    Little Rock, Arkansas, 72204, United States

  • Marea Site 314

    ACTIVE_NOT_RECRUITING

    Greenville, South Carolina, 29607, United States

  • Marea Site 315

    ACTIVE_NOT_RECRUITING

    Winston-Salem, North Carolina, 27104, United States

  • Marea Site 316

    ACTIVE_NOT_RECRUITING

    Baltimore, Maryland, 21229, United States

  • Marea Site 317

    ACTIVE_NOT_RECRUITING

    Park Ridge, Illinois, 60068, United States

  • Marea Site 318

    ACTIVE_NOT_RECRUITING

    New Windsor, New York, 12553, United States

  • Marea Site 319

    RECRUITING

    Peachtree Corners, Georgia, 30092, United States

  • Marea Site 320

    RECRUITING

    Little River, South Carolina, 29566, United States

  • Marea Site 321

    ACTIVE_NOT_RECRUITING

    Manassas, Virginia, 20109, United States

  • Marea Site 322

    ACTIVE_NOT_RECRUITING

    Amarillo, Texas, 79124, United States

  • Marea Site 325

    RECRUITING

    Springfield, Illinois, 62702, United States

  • Marea Site 326

    RECRUITING

    Memphis, Tennessee, 38119, United States

  • Marea Site 328

    ACTIVE_NOT_RECRUITING

    Anniston, Alabama, 36207, United States

  • Marea Site 329

    ACTIVE_NOT_RECRUITING

    Mobile, Alabama, 36608, United States

  • Marea Site 330

    ACTIVE_NOT_RECRUITING

    Kansas City, Missouri, 64151, United States

  • Marea Site 401

    RECRUITING

    Chicoutimi, Quebec, G7H 7K9, Canada

  • Marea Site 402

    RECRUITING

    Montreal, Quebec, H1T 1C8, Canada

  • Marea Site 403

    ACTIVE_NOT_RECRUITING

    London, Ontario, N5W6A2, Canada

  • Marea Site 404

    RECRUITING

    Sarnia, Ontario, N7T 4X3, Canada

  • Marea Site 405

    RECRUITING

    Québec, Quebec, G1G 3Y8, Canada

  • Marea Site 406

    RECRUITING

    Concord, Ontario, L4K 4M2, Canada

  • Marea Site 407

    RECRUITING

    Québec, Quebec, G1V 4M6, Canada

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