Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000992303p
Ethics application status
Help: Ethics application status
Not yet submitted
Date submitted
Help: Date submitted
4/08/2026
Date registered
Help: Date registered
12/08/2026
Date last updated
Help: Date last updated
12/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
12/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Phase 1b Study to Evaluate the Safety and Effects of Multiple Doses of MAR005 in People with High Triglycerides in the Blood
Scientific title
Phase 1b, open-label evaluation of the safety, tolerability, PK and PD of repeated doses of MAR005 in participants with Hypertriglyceridaemia
Additional trial identifiers [1] 318012 0
Nil
Universal Trial Number (UTN)
Trial acronym
MT5-101
Related trial records

Health condition
Health condition(s) studied:
Hypertriglyceridaemia 343008 0
Condition category
Condition code
Metabolic and Endocrine 339101 339101 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Up to 10 participants with high triglycerides will be receiving MAR005.

MAR005 is a monoclonal antibody designed to block angiopoietin-like 4.

Investigational product: 300 mg dose of MAR005 for subcutaneous (SC) injection administered by site staff on Day 1 and Day 29.

Participants will be screened within 42 days before their first dose of trial intervention and will attend the Clinical Unit for 2 screening visits, separated by at least 7 days.

They will attend the Clinical Unit for outpatient dosing visits, remaining in the Clinical Unit until at least 6 h after dosing. Participants will be evaluated for safety throughout the trial and will attend the Clinical Unit for 11 additional outpatient visits

Adherence to the intervention will be monitored through direct administration of all doses by qualified study personnel at the Clinical Research Unit. Dosing will be documented in source records and drug accountability records, and participants will be monitored according to the protocol-defined schedule.
Intervention code [1] 334882 0
Treatment: Drugs
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346342 0
safety and tolerability assessment following multiple dose subcutaneous administration of MAR005 evaluated by the incidence of adverse events (AEs), changes in vital signs, electrocardiograms (ECGs), clinical laboratory parameters, physical assessments in healthy participants with Elevated triglycerides (Composite Primary outcome)
Timepoint [1] 346342 0
From Day 1 to Day 85 (EOT)
Secondary outcome [1] 465480 0
Pharmacokinetics (PK) of MAR005 following multiple Subcutaneous doses in participants with Elevated triglycerides
Timepoint [1] 465480 0
Pre dose on Day 1. Post dose at 6 hr on Day 1, Day 4, Day 8, Day 10, Day 15, Day 22, Pre dose on Day 29, Post dose at 6 hr on Day 29, Day 32, Day 36, Day 43, Day 50, Day 57, and Day 85 (EOT)

Eligibility
Key inclusion criteria
1. Fasting triglycerides (TG) value more than or equal to 150 mg/dL at both screening visits 1 and 2 (separated by at least 7 days)
2. Stable drug regimen (if relevant) prior to first screening visit and no planned changes during screening or trial participation. A stable drug regimen is defined as use of any of the following medications at a stable dose for at least the duration specified below:
• Lipid-lowering therapies > 4 weeks
• Beta-blockers, thiazide diuretics > 4 weeks
• Diabetes mellitus medications (except glucagon-like peptide-1 [GLP-1] or dual-acting GLP-1/glucose-dependent insulinotropic polypeptide [GIP] receptor agonists) > 4 weeks
• GLP-1 or dual-acting GLP-1/GIP receptor agonists > 12 weeks
• Atypical antipsychotics > 12 weeks
• Systemic estrogens, tamoxifen, raloxifene > 16 weeks
3. Body weight more than or equal to 50 kg.
4. Negative pregnancy test at screening and admission (female participants only).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. History of Type 1 Diabetes Mellitus (T1DM) or history of Diabetic Ketoacidosis (DKA).
2. Poorly controlled Type 2 Diabetes Mellitus (T2DM) with HbA1c more than or equal to 8.0% at screening.
3. Newly diagnosed T2DM (within 6 months of randomization) or laboratory evidence of T2DM during screening (fasting HbA1c more than or equal to 6.5%) without prior diagnosis).
4. Uncontrolled hypertension (blood pressure > 150/90 mm Hg) at either of the 2 screening visits.
5. Current heavy smoker (> 10 cigarettes per day) or equivalent use of any other nicotine product, and/or unwilling to abstain from smoking or using other nicotine products during dosing visits.
6. Use of/unable to refrain from using Angiopoietin-like Protein 3 (ANGPTL3) or Apolipoprotein C-III (ApoC-III) inhibitors (e.g. olezarsen and plozasiran), from 12 months before screening until the end of the trial.
7. Clinically relevant abnormal history, physical findings, ECG, vital signs, or laboratory values at the screening assessment that could interfere with the objectives of the trial or the safety of the participant.
8. History of anaphylaxis or other significant allergy in the opinion of the Investigator.
9. Use of any monoclonal antibody therapy in the 6 months before screening, or history of hypersensitivity to any monoclonal antibody, or to any of the excipients used in the trial interventions
10 History of cancer within 3 years of screening
11. Positive test for HIV antibody, hepatitis B surface antigen, or hepatitis C antibody.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2026
Actual
Date of last participant enrolment
Anticipated
28/02/2027
Actual
Date of last data collection
Anticipated
30/05/2027
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 322559 0
Commercial sector/Industry
Name [1] 322559 0
Marea Therapeutics, Inc.
Country [1] 322559 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Marea Therapeutics, Inc.
Address
Country
United States of America
Secondary sponsor category [1] 325480 0
None
Name [1] 325480 0
Address [1] 325480 0
Country [1] 325480 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 321037 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 321037 0
Ethics committee country [1] 321037 0
Australia
Date submitted for ethics approval [1] 321037 0
12/08/2026
Approval date [1] 321037 0
Ethics approval number [1] 321037 0

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

Contacts
Principal investigator
Name 152454 0
Dr Phillip Ryan
Address 152454 0
Nucleus Network, Level 5, Burnet Tower, 89 Commercial Rd, Melbourne, Victoria, 3004
Country 152454 0
Australia
Phone 152454 0
+61 03 8593 9801
Fax 152454 0
Email 152454 0
[email protected]
Contact person for public queries
Name 152455 0
Dr. Phillip Ryan
Address 152455 0
Nucleus Network, Level 5, Burnet Tower, 89 Commercial Rd, Melbourne, Victoria, 3004
Country 152455 0
Australia
Phone 152455 0
+61 03 8593 9801
Fax 152455 0
Email 152455 0
[email protected]
Contact person for scientific queries
Name 152456 0
Alex Yi
Address 152456 0
Marea Therapeutics- 131 Oyster Point Blvd, 4th Floor, South San Francisco, CA 94080
Country 152456 0
United States of America
Phone 152456 0
+1 415 766 3610
Fax 152456 0
Email 152456 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.