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HypertriglyceridemiaPhase 2TYDAL-TIMI 78NCT07028749

Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol

A Phase 2 study testing MAR001 in people with Hypertriglyceridemia, run by Marea Therapeutics at 55 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hypertriglyceridemia
What is being tested?
MAR001
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
316 participants
Where
55 sitesin 4 countries
Study dates
30 Jun 2025to Apr 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

55 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Matty Hughes contact

415-766-3610

TYDAL_info@mareatx.com

55 sites in 4 countries

United States26 sites, 7 recruiting

  • Marea Site 322

    Amarillo, Texas, 79124

    Active, not recruiting

  • Marea Site 328

    Anniston, Alabama, 36207

    Active, not recruiting

  • Marea Site 316

    Baltimore, Maryland, 21229

    Active, not recruiting

  • Marea Site 302

    Boca Raton, Florida, 33434

    Recruiting

  • Marea Site 310

    Columbus, Georgia, 31904

    Active, not recruiting

  • Marea Site 304

    Great Neck, New York, 11021

    Active, not recruiting

  • Marea Site 303

    Greensboro, North Carolina, 27405

    Active, not recruiting

  • Marea Site 314

    Greenville, South Carolina, 29607

    Active, not recruiting

  • Marea Site 306

    Hamden, Connecticut, 06517

    Active, not recruiting

  • Marea Site 330

    Kansas City, Missouri, 64151

    Active, not recruiting

  • Marea Site 320

    Little River, South Carolina, 29566

    Recruiting

  • Marea Site 313

    Little Rock, Arkansas, 72204

    Active, not recruiting

  • Marea Site 301

    Louisville, Kentucky, 40213

    Active, not recruiting

  • Marea Site 321

    Manassas, Virginia, 20109

    Active, not recruiting

  • Marea Site 308

    McKinney, Texas, 75071

    Active, not recruiting

  • Marea Site 326

    Memphis, Tennessee, 38119

    Recruiting

  • Marea Site 329

    Mobile, Alabama, 36608

    Active, not recruiting

  • Marea Site 318

    New Windsor, New York, 12553

    Active, not recruiting

  • Marea Site 317

    Park Ridge, Illinois, 60068

    Active, not recruiting

  • Marea Site 319

    Peachtree Corners, Georgia, 30092

    Recruiting

  • Marea Site 307

    Port Saint Lucie, Florida, 34952

    Recruiting

  • Marea Site 312

    San Antonio, Texas, 78229

    Active, not recruiting

  • Marea Site 325

    Springfield, Illinois, 62702

    Recruiting

  • Marea Site 305

    St Louis, Missouri, 63110

    Recruiting

  • Marea Site 309

    Tacoma, Washington, 98405

    Active, not recruiting

  • Marea Site 315

    Winston-Salem, North Carolina, 27104

    Active, not recruiting

Other trials in United States

Australia13 sites, 5 recruiting

  • Marea Site 103

    Canberra, Australian Capital Territory, 2617

    Active, not recruiting

  • Marea Site 102

    Clayton, Victoria, 3168

    Recruiting

  • Marea Site 110

    Heidelberg Heights, Victoria, 3081

    Active, not recruiting

  • Marea Site 108

    Herston, Queensland, 4006

    Active, not recruiting

  • Marea Site 113

    Hoppers Crossing, Victoria, 3029

    Active, not recruiting

  • Marea Site 105

    Kanwal, New South Wales, 2259

    Active, not recruiting

  • Marea Site 111

    Leabrook, South Australia, 5068

    Recruiting

  • Marea Site 107

    Merewether, New South Wales, 2291

    Active, not recruiting

  • Marea Site 104

    Milton, Queensland, 4064

    Recruiting

  • Marea Site 106

    Miranda, New South Wales, 2228

    Active, not recruiting

  • Marea Site 101

    Nedlands, Western Australia, 6009

    Recruiting

  • Marea Site 112

    Perth, Western Australia, 6000

    Recruiting

  • Marea Site 109

    Wollongong, New South Wales, 2500

    Active, not recruiting

Other trials in Australia

New Zealand9 sites, 3 recruiting

  • Marea Site 211

    Birkenhead, Auckland, 0626

    Recruiting

  • Marea Site 206

    Christchurch, South Island, 8013

    Recruiting

  • Marea Site 209

    Christchurch, 4710

    Active, not recruiting

  • Marea Site 202

    Christchurch

    Active, not recruiting

  • Marea Site 204

    Ebdentown, Upper Hutt, 5018

    Active, not recruiting

  • Marea Site 207

    New Lynn, Auckland, 0600

    Active, not recruiting

  • Marea Site 203

    Papatoetoe, Auckland, 2025

    Active, not recruiting

  • Marea Site 208

    Rotorua, 3010

    Active, not recruiting

  • Marea Site 205

    Silverdale, Auckland, 0932

    Recruiting

Other trials in New Zealand

Canada7 sites, 6 recruiting

  • Marea Site 401

    Chicoutimi, Quebec, G7H 7K9

    Recruiting

  • Marea Site 406

    Concord, Ontario, L4K 4M2

    Recruiting

  • Marea Site 403

    London, Ontario, N5W6A2

    Active, not recruiting

  • Marea Site 402

    Montreal, Quebec, H1T 1C8

    Recruiting

  • Marea Site 405

    Québec, Quebec, G1G 3Y8

    Recruiting

  • Marea Site 407

    Québec, Quebec, G1V 4M6

    Recruiting

  • Marea Site 404

    Sarnia, Ontario, N7T 4X3

    Recruiting

Other trials in Canada

About this study

Official title: Phase 2b Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of MAR001 in Patients With Elevated Triglycerides and Remnant Cholesterol (TYDAL-TIMI 78)

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.

Read the 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.

Being tested
MAR001, Placebo
Keywords
Hypertriglyceridemia, MAR001, Remnant Cholesterol, TYDAL, TIMI-78
Medical subject headings
Hypertriglyceridemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MAR001Drug

    Subcutaneous Injection

  • PlaceboDrug

    Subcutaneous injection

Study groups in NCT07028749
Study groupRoleWhat they receive
MAR001 Dose 1 (Part A)ExperimentalSubcutaneous injection
Receives: Drug: MAR001; Drug: Placebo
MAR001 Dose 2 (Part A)ExperimentalSubcutaneous Injection
Receives: Drug: MAR001; Drug: Placebo
MAR001 Dose 3 (Part A)ExperimentalSubcutaneous Injection
Receives: Drug: MAR001; Drug: Placebo
MAR001 Dose 4 (Part B)ExperimentalSubcutaneous Injection
Receives: Drug: MAR001; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Endpoint

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

    Measured: 12 weeks

Secondary outcomes (4)

  1. Secondary Endpoint

    Proportion of participants with

    Part A: baseline TG ≥150 mg/dL achieving TG <150 mg/dL at Week 12 compared to placebo

    Part B: baseline TG ≥500 mg/dL achieving TG <500 mg/dL at Week 12 compared to placebo

    Measured: 12 weeks

  2. Secondary Endpoint

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

    Measured: 12 weeks

  3. Secondary Endpoint

    Percent change from baseline at Week 16 in non-fasting TG compared to placebo

    Measured: 16 weeks

  4. Secondary Endpoint

    Part A only: Percent change from baseline at Week 12 in fasting TG compared to placebo in participants with baseline TG ≥300 mg/dL

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2025
  2. Study start30 Jun 2025
  3. Primary completionNov 2027 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
316 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07028749
Sponsor's protocol ID
MAR-103
Acronym
TYDAL-TIMI 78
Status last verified
Sep 2026
First submitted
11 Jun 2025
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MAR001 in people with Hypertriglyceridemia, run by Marea Therapeutics at 55 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, Australia, New Zealand, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Matty Hughes (415-766-3610, TYDAL_info@mareatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Endpoint (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07028749.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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