Hypertriglyceridemia
Conditions
Brief summary
The purpose of this study is to evaluate the safety and tolerability of multiple doses of MAR001in adult volunteers with metabolic dysfunction.
Interventions
DRUGMAR001
Subcutaneous injection
DRUGPlacebo
Subcutaneous injection
Sponsors
Marea Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of MAR001 | 12 weeks | Incidence and frequency of treatment-emergent adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of MAR001 on triglyceride metabolism | 12 weeks | Change from baseline in triglyceride levels |
Countries
Australia
Outcome results
None listed