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Study of MAR001 in Adults With Metabolic Dysfunction

NCT ID: NCT05896254

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-22

Study Completion Date

2024-12-13

Brief Summary

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

Detailed Description

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Conditions

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Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MAR001

Subcutaneous injection

Group Type EXPERIMENTAL

MAR001

Intervention Type DRUG

Subcutaneous injection

Placebo

Subcutaneous injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneous injection

Interventions

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MAR001

Subcutaneous injection

Intervention Type DRUG

Placebo

Subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marea Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alex DePaoli

Role: STUDY_DIRECTOR

Marea Tx

Locations

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Brisbane Site

Brisbane, , Australia

Site Status

Melbourne Site

Melbourne, , Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED
PMID: 40383129 (View on PubMed)

Other Identifiers

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MAR-102

Identifier Type: -

Identifier Source: org_study_id