Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05896254




Registration number
NCT05896254
Ethics application status
Date submitted
31/05/2023
Date registered
9/06/2023
Date last updated
20/03/2024

Titles & IDs
Public title
Study of MAR001 in Adults With Metabolic Dysfunction
Scientific title
A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled Study of the Safety and Efficacy of MAR001 in Patients With Metabolic Dysfunction
Secondary ID [1] 0 0
MAR-102
Universal Trial Number (UTN)
Trial acronym
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 - Subcutaneous injection

Placebo Comparator: Placebo - 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
Safety and tolerability of MAR001
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Effect of MAR001 on triglyceride metabolism
Timepoint [1] 0 0
12 weeks

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
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 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2024
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Brisbane Site - Brisbane
Recruitment hospital [2] 0 0
Melbourne Site - Melbourne
Recruitment postcode(s) [1] 0 0
4006 - Brisbane
Recruitment postcode(s) [2] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Marea Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and tolerability of multiple doses of
MAR001in adult volunteers with metabolic dysfunction.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05896254
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alex DePaoli
Address 0 0
Marea Tx
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jennifer Tam
Address 0 0
Country 0 0
Phone 0 0
415-766-3610
Fax 0 0
Email 0 0
jtam@mareatx.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05896254