Hypertriglyceridemia
Conditions
Keywords
Hypertriglyceridemia, MAR001, Remnant Cholesterol, TYDAL, TIMI-78
Brief summary
The primary objective of the study is to evaluate the effect of MAR001 compared to placebo on levels of TG in adults with elevated TG and RC.
Detailed description
MAR-103 is a randomized, double-blind, parallel-group, placebo-controlled study with two parts (Part A and Part B). In both Part A and Part B, participants will be randomized at Day 1. The study will include a screening period (up to 8 weeks), a 24-week treatment period, and a 12-week safety follow-up period. The 12-week safety follow-up period will include 2 clinic visits at Week 28 and Week 36 (End of Study). Part A: Approximately 216 participants with baseline TG between 150 to 880 mg/dL will be enrolled in Part A at a 3:1 ratio of MAR001 to placebo for dosing every 4 weeks (Q4W). Three doses of MAR001 will be administered. Part B: Approximately 100 participants with baseline TG between 450 and 2000 mg/dL will be enrolled in Part B at a 1:1 ratio of MAR001 to placebo for dosing every 4 weeks (Q4W). The MAR001 dose will be within the range tested during Part A and will be selected based on emerging Part A data.
Interventions
DRUGMAR001
Subcutaneous Injection
DRUGPlacebo
Subcutaneous injection
Sponsors
Marea Therapeutics
The TIMI Study Group
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 75 Years
Healthy volunteers
No
Inclusion criteria
* Elevated fasting TGs and RC * Elevated nonfasting TGs and RC * Part A only: 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 during screening or trial participation * Stable drug regimen (if relevant) prior to screening visit and no planned changes after enrollment; Part B only: adjustment of lipid-lowering therapy during the diet/lifestyle run-in period is permitted
Exclusion criteria
* Acute or chronic liver disease * Part A only: TG concentration ≥880mg/dl; Part B only: TG concentration ≥2000 mg/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 * Part B only: recent history of active pancreatitis * Part B only: genetically confirmed Familial Chylomicronemia Syndrome (FCS) diagnosis due to biallelic loss of function mutations in LPL or GPIHBP1 * Part B only: use of ANGPTL3 and ApoC-III inhibitors * Any condition that prevents the participant from complying with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint | 12 weeks | Percent change from baseline at Week 12 in fasting TG compared to placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoint | 12 weeks | Proportion of participants with Part A: baseline TG ≥150 mg/dL achieving TG \<150 mg/dL at Week 12 compared to placebo Part B: baseline TG ≥500 mg/dL achieving TG \<500 mg/dL at Week 12 compared to placebo |
Countries
Australia, Canada, New Zealand, United States
Contacts
CONTACTMatty Hughes
Outcome results
None listed