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OpenTrials
Completed

NCT Number: NCT05896254

Study of MAR001 in Adults 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.

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Key information

Conditions

Hypertriglyceridemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Brisbane Site, Brisbane, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MAR001

Drug

Subcutaneous injection

Placebo

Drug

Subcutaneous injection

Primary outcomes

  1. Safety and tolerability of MAR001

    Time frame: 12 weeks

    Incidence and frequency of treatment-emergent adverse events

Secondary outcomes

  1. Effect of MAR001 on triglyceride metabolism

    Time frame: 12 weeks

    Change from baseline in triglyceride levels

Sponsors and collaborators

Lead sponsor

Marea Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 9, 2023
Registry last updated
Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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