ClinicalTrials.gg
RecruitingNCT07199309Updated Nov 6, 2025

A Mechanistic Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol

A Phase 2 interventional study of MAR001 and Placebo in Hypertriglyceridemia, sponsored by Marea Therapeutics. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-06.

Sponsored by Marea Therapeutics · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Sep 2025; still recruiting 1 year 1 month later.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The primary objective of the study is to determine the effect of MAR001 as compared to placebo on levels of the triglycerides (TG) in the postprandial state in adults with elevated TG.

02

Conditions studied

  • Hypertriglyceridemia

Browse trials for

Keywords

  • Remnant Cholesterol
  • MAR001
  • Hypertriglyceridemia
03

In context

Hypertriglyceridemia

324 studies on the registry are indexed under Hypertriglyceridemia; 38 are open to participants now.

This study's planned enrollment of 30 is below the median of 66 across 288 interventional studies indexed under Hypertriglyceridemia.

Browse Hypertriglyceridemia studies →

Lead sponsor

Marea Therapeutics is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Willingness to provide and comply with the intervention and all study assessments
  • Two fasting TG collected at two separate, consecutive visits at least 7 days apart during the Screening period
  • ≥ 5.7% and ≤ 8.5%
  • Stable diet for a minimum of 3 months prior to screening and with no plans to change diet through duration of study
  • Stable drug regimen (appropriate if relevant) prior to screening visit and no planned changes during screening or trial participation

Exclusion criteria

Exclusion Criteria:

  • Acute or chronic liver disease
  • Diabetes medications (other than metformin)
  • History of type 1 diabetes mellitus or history of diabetic ketoacidosis
  • Newly diagnosed T2DM
  • Participants with known active hepatitis A, B, or C
  • Participants who are known to have uncontrolled (HIV) infection
  • Uncontrolled hypothyroidism
  • Any condition that prevents the participant from complying with study procedures
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    MAR001 Dose

    Subcutaneous Injection

    Drug: MAR001

  • Placebo comparator
    Matching Placebo

    Drug: Placebo

Interventions

  • DrugMAR001

    Subcutaneous Injection

  • DrugPlacebo

    Subcutaneous Injection

06

What researchers measure

Primary outcomes

  1. Change from baseline in TG area under the curve after a mixed meal

    Time frame: 12 weeks

  2. Change from baseline in peak plasma TG concentration after a mixed meal

    Time frame: 12 weeks

Secondary outcomes

  1. Change from baseline in RC area under the curve after a mixed meal

    Time frame: 12 weeks

  2. Change from baseline in peak plasma RC concentration after a mixed meal

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
  • Marea Site 301
    Chula Vista, California 91911, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Jul 2026, 10 months after the start.

Of 23 phase 2 interventional studies under Hypertriglyceridemia, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 10 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 22, 2025
First posted
Sep 30, 2025
StartActual
Sep 26, 2025
Primary completionEst.
Jul 2026
CompletionEst.
Nov 2026
Last update
Nov 6, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07199309
Lead sponsor
Marea Therapeutics
Responsible party
Sponsor
First posted
Sep 30, 2025
Start date
Sep 26, 2025
Primary completion
Jul 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Nov 6, 2025

Study contacts

Andrew Lane
Contact
MAR-104-info@mareatx.com
415-766-3610

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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Studies of the drug tested here: MAR001

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