Study of MAR001 in Adults With Metabolic Dysfunction

November 11, 2025 updated by: Marea Therapeutics

A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled Study of the Safety and Efficacy of MAR001 in Patients With Metabolic Dysfunction

The purpose of this study is to evaluate the safety and tolerability of multiple doses of MAR001in adult volunteers with metabolic dysfunction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Brisbane, Australia, 4006
        • Brisbane Site
      • Melbourne, Australia, 3004
        • Melbourne Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Willingness to provide informed consent and comply with the intervention
  • Women of childbearing potential and men agreeing to use an appropriate method of contraception for the duration of the study
  • Evidence of metabolic dysfunction at screening (triglyceride levels > 2.8 mmol/L)

Exclusion Criteria:

  • Any condition which in the opinion of the investigator prevents the participant from complying with study procedures or prevents the participant from completing the study or interferes with the interpretation of study results
  • Pregnant or breastfeeding mothers
  • Terminal illness with expected survival of less than 1 year

Note: additional inclusion/exclusion criteria may apply, per protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Subcutaneous injection
Drug: Placebo
Subcutaneous injection
Experimental: MAR001
Subcutaneous injection
Drug: MAR001
Subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of MAR001
Time Frame: 12 weeks
Incidence and frequency of treatment-emergent adverse events
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of MAR001 on triglyceride metabolism
Time Frame: 12 weeks
Change from baseline in triglyceride levels
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marea Therapeutics

Investigators

  • Study Director: Alex DePaoli, Marea Tx

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2023

Primary Completion (Actual)

December 13, 2024

Study Completion (Actual)

December 13, 2024

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 9, 2023

Study Record Updates

Last Update Posted (Estimated)

November 13, 2025

Last Update Submitted That Met QC Criteria

November 11, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAR-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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