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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07028749




Registration number
NCT07028749
Ethics application status
Date submitted
11/06/2025
Date registered
19/06/2025
Date last updated
19/06/2025

Titles & IDs
Public title
Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol
Scientific title
Phase 2b Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of MAR001 in Patients With Elevated Triglycerides and Remnant Cholesterol (TYDAL-TIMI 78)
Secondary ID [1] 0 0
MAR-103
Universal Trial Number (UTN)
Trial acronym
TYDAL-TIMI 78
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertriglyceridemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MAR001
Treatment: Drugs - Placebo

Experimental: MAR001 Dose 1 - Subcutaneous injection

Experimental: MAR001 Dose 2 - Subcutaneous Injection

Experimental: MAR001 Dose 3 - Subcutaneous Injection


Treatment: Drugs: MAR001
Subcutaneous Injection

Treatment: Drugs: Placebo
Subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Endpoint
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Secondary Endpoint
Timepoint [1] 0 0
12 weeks

Eligibility
Key inclusion criteria
* Elevated fasting TGs and RC
* Elevated nonfasting TGs and RC
* Fasting LDL-C = 50 mg/dL (= 1.29 mmol/L) and = 130 mg/dL (= 3.36 mmol/L)
* Willingness to provide informed consent and comply with the intervention and all study assessments
* Stable diet for a minimum of 3 months prior to screening and with no plans to change diet through duration of study
* Stable drug regimen (if relevant) prior to screening visit and no planned changes during screening or trial participation
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Acute or chronic liver disease
* TG concentration =880mg/dl
* History of type 1 diabetes mellitus or history of diabetic ketoacidosis
* Newly diagnosed T2DM
* Participants with known active hepatitis A, B, or C
* Uncontrolled hypothyroidism
* Any condition that prevents the participant from complying with study procedures

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
216
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Marea Site 101 - Nedlands
Recruitment postcode(s) [1] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Kentucky

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Marea Therapeutics
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The TIMI Study Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Andrew Lane
Address 0 0
Country 0 0
Phone 0 0
415-766-3610
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07028749