Clinical trial for Hypertriglyceridemia
Official title Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol
ClinicalTrials.gov ID: NCT07028749
What this study is testing
What is MAR001?
MAR001 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hypertriglyceridemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Anniston, Alabama, United States
- Mobile, Alabama, United States
- Little Rock, Arkansas, United States
- Hamden, Connecticut, United States
- Boca Raton, Florida, United States
- Port Saint Lucie, Florida, United States
- Columbus, Georgia, United States
- Peachtree Corners, Georgia, United States
- Park Ridge, Illinois, United States
- Springfield, Illinois, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- Great Neck, New York, United States
- New Windsor, New York, United States
- Greensboro, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Greenville, South Carolina, United States
- Little River, South Carolina, United States
+ 33 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anniston, Alabama, United States; Mobile, Alabama, United States; Little Rock, Arkansas, United States; Hamden, Connecticut, United States; Boca Raton, Florida, United States; Port Saint Lucie, Florida, United States and 47 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.