Back to resultsStudy of MAR001 in Adults With Metabolic Dysfunction
Primary Purpose
Hypertriglyceridemia
Status
Recruiting
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
MAR001
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypertriglyceridemia
Eligibility Criteria
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
Sites / Locations
- Brisbane SiteRecruiting
- Melbourne SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MAR001
Placebo
Arm Description
Subcutaneous injection
Subcutaneous injection
Outcomes
Primary Outcome Measures
Safety and tolerability of MAR001
Incidence and frequency of treatment-emergent adverse events
Secondary Outcome Measures
Effect of MAR001 on triglyceride metabolism
Change from baseline in triglyceride levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05896254
Brief Title
Study of MAR001 in Adults With Metabolic Dysfunction
Official Title
A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled Study of the Safety and Efficacy of MAR001 in Patients With Metabolic Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marea Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of multiple doses of MAR001in adult volunteers with metabolic dysfunction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MAR001
Arm Type
Experimental
Arm Description
Subcutaneous injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
MAR001
Intervention Description
Subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous injection
Primary Outcome Measure Information:
Title
Safety and tolerability of MAR001
Description
Incidence and frequency of treatment-emergent adverse events
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Effect of MAR001 on triglyceride metabolism
Description
Change from baseline in triglyceride levels
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Tam
Phone
415-766-3610
Email
jtam@mareatx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex DePaoli
Organizational Affiliation
Marea Tx
Official's Role
Study Director
Facility Information:
Facility Name
Brisbane Site
City
Brisbane
ZIP/Postal Code
4006
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brisbane PI
Facility Name
Melbourne Site
City
Melbourne
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melbourne PI
12. IPD Sharing Statement
Learn more about this trial
Study of MAR001 in Adults With Metabolic Dysfunction
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