Recruiting
Phase 2

MAR001

Sponsor:

Marea Therapeutics

Code:

NCT07199309

Conditions

Hypertriglyceridemia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

MAR001

Placebo

Study Details

Brief 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.

Conditions

Hypertriglyceridemia

Study ID

NCT07199309

Start date

Sep 26, 2025

Status verified date

Nov, 2025

Completion date

Nov, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Willingness to provide informed consent 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
  • HbA1c ≥ 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:

  • 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 human immunodeficiency virus (HIV) infection
  • Uncontrolled hypothyroidism
  • Any condition that prevents the participant from complying with study procedures

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MAR001 Dose

Subcutaneous Injection

placebo comparator: Matching Placebo

Interventions

MAR001

Subcutaneous Injection

Placebo

Subcutaneous Injection

Primary outcome measure

  • Change from baseline in TG area under the curve after a mixed meal [ Time Frame: 12 weeks ]
  • Change from baseline in peak plasma TG concentration after a mixed meal [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Andrew Lane

415-766-3610MAR-104-info@mareatx.com

Locations

Marea Site 301

Recruiting

Chula Vista, California, United States, 91911

More Information

Sponsor

Marea Therapeutics

Last update posted

Nov 6, 2025

Last verified

Nov, 2025

Keywords

  • Remnant Cholesterol
  • MAR001
  • Hypertriglyceridemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Marea Therapeutics on 2025-11-06.