A Mechanistic Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol
Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of MAR001 on Postprandial Lipids in Patients With Elevated Triglycerides and Remnant Cholesterol
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2025
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2025
CompletedStudy Start
First participant enrolled
September 26, 2025
CompletedFirst Posted
Study publicly available on registry
September 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
November 6, 2025
November 1, 2025
9 months
September 22, 2025
November 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from baseline in TG area under the curve after a mixed meal
12 weeks
Change from baseline in peak plasma TG concentration after a mixed meal
12 weeks
Secondary Outcomes (2)
Change from baseline in RC area under the curve after a mixed meal
12 weeks
Change from baseline in peak plasma RC concentration after a mixed meal
12 weeks
Study Arms (2)
MAR001 Dose
EXPERIMENTALSubcutaneous Injection
Matching Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marea Site 301
Chula Vista, California, 91911, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2025
First Posted
September 30, 2025
Study Start
September 26, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
November 6, 2025
Record last verified: 2025-11