Study of MAR001 in Adults With Metabolic Dysfunction
A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled Study of the Safety and Efficacy of MAR001 in Patients With Metabolic Dysfunction
1 other identifier
interventional
55
1 country
2
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of multiple doses of MAR001in adult volunteers with metabolic dysfunction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2023
2 active sites
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
May 31, 2023
CompletedFirst Posted
Study publicly available on registry
June 9, 2023
CompletedStudy Start
First participant enrolled
July 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2024
CompletedNovember 13, 2025
November 1, 2025
1.4 years
May 31, 2023
November 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and tolerability of MAR001
Incidence and frequency of treatment-emergent adverse events
12 weeks
Secondary Outcomes (1)
Effect of MAR001 on triglyceride metabolism
12 weeks
Study Arms (2)
MAR001
EXPERIMENTALSubcutaneous injection
Placebo
PLACEBO COMPARATORSubcutaneous injection
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Brisbane Site
Brisbane, 4006, Australia
Melbourne Site
Melbourne, 3004, Australia
Related Publications (1)
Cummings BB, Joing MP, Bouchard PR, Milton MN, Moesta PF, Ramanan V, Lane A, Hirman J, Trauger JW, Maratos-Flier E, Voznesensky A, Splawski I, Nimonkar AV, Flaherty MM, Yi BA, Meyers D, Huet F, Sahambi SK, Yates DP, Hom D, Hinder M, Basson CT, O'Donnell C, Siegelman ES, Garrett CE, Lehrer-Graiwer J, Juliano RA, Weiss EJ. Safety and efficacy of a novel ANGPTL4 inhibitory antibody for lipid lowering: results from phase 1 and phase 1b/2a clinical studies. Lancet. 2025 May 31;405(10493):1923-1934. doi: 10.1016/S0140-6736(25)00825-6. Epub 2025 May 15.
PMID: 40383129DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alex DePaoli
Marea Tx
Study Design
- Study Type
- interventional
- Phase
- phase 1
- 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
May 31, 2023
First Posted
June 9, 2023
Study Start
July 22, 2023
Primary Completion
December 13, 2024
Study Completion
December 13, 2024
Last Updated
November 13, 2025
Record last verified: 2025-11