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NCT05896254 Clinical Trial

Study of MAR001 in Adults With Metabolic Dysfunction

Hypertriglyceridemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05896254
Other study ID # MAR-102
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date July 22, 2023
Est. completion date November 2024

Study information
Verified date March 2024
Source Marea Therapeutics
Contact Jennifer Tam
Phone 415-766-3610
Email jtam@mareatx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 48
Est. completion date November 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• MAR001
Subcutaneous injection
• Placebo
Subcutaneous injection

Locations
Country Name City State
Australia Brisbane Site Brisbane
Australia Melbourne Site Melbourne

Sponsors (1)
Lead Sponsor Collaborator
Marea Therapeutics

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and tolerability of MAR001 Incidence and frequency of treatment-emergent adverse events 12 weeks
Secondary Effect of MAR001 on triglyceride metabolism Change from baseline in triglyceride levels 12 weeks
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