Study of MAR001 in Adults With Metabolic Dysfunction

Phase 1

Completed

• Conditions: Hypertriglyceridemia
• Interventions: Drug: MAR001; Drug: Placebo

• Registration Number: NCT05896254
• Lead Sponsor: Marea Therapeutics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-05-31
• Study First Posted: 2023-06-09
• Study Start: 2023-07-22
• Primary Completion: 2024-12-13
• Study Completion: 2024-12-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MAR001	MAR001	Subcutaneous injection
Placebo	Placebo	Subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of MAR001	12 weeks	Incidence and frequency of treatment-emergent adverse events

Secondary Outcome Measures

Name	Time	Method
Effect of MAR001 on triglyceride metabolism	12 weeks	Change from baseline in triglyceride levels

Trial Locations

Locations (2)

Brisbane Site; 🇦🇺 Brisbane, Australia

Melbourne Site; 🇦🇺 Melbourne, Australia