Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol
Recruiting · NCT07028749 · Interventional (participants receive a specific treatment) · Lead sponsor: Marea Therapeutics
View the official record on ClinicalTrials.gov →Interventions studied
MAR001Placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
55 locations listed across 16 US states.
- Marea Site 328 - Anniston, Alabama, United States
- Marea Site 329 - Mobile, Alabama, United States
- Marea Site 313 - Little Rock, Arkansas, United States
- Marea Site 306 - Hamden, Connecticut, United States
- Marea Site 302 - Boca Raton, Florida, United States
- Marea Site 307 - Port Saint Lucie, Florida, United States
- Marea Site 310 - Columbus, Georgia, United States
- Marea Site 319 - Peachtree Corners, Georgia, United States
- Marea Site 317 - Park Ridge, Illinois, United States
- Marea Site 325 - Springfield, Illinois, United States
- Marea Site 301 - Louisville, Kentucky, United States
- Marea Site 316 - Baltimore, Maryland, United States
- Marea Site 330 - Kansas City, Missouri, United States
- Marea Site 305 - St Louis, Missouri, United States
- Marea Site 304 - Great Neck, New York, United States
- Marea Site 318 - New Windsor, New York, United States
- Marea Site 303 - Greensboro, North Carolina, United States
- Marea Site 315 - Winston-Salem, North Carolina, United States
- Marea Site 314 - Greenville, South Carolina, United States
- Marea Site 320 - Little River, South Carolina, United States
- Marea Site 326 - Memphis, Tennessee, United States
- Marea Site 322 - Amarillo, Texas, United States
- Marea Site 308 - McKinney, Texas, United States
- Marea Site 312 - San Antonio, Texas, United States
- Marea Site 321 - Manassas, Virginia, United States
- Marea Site 309 - Tacoma, Washington, United States
- Marea Site 209 - Christchurch, New Zealand
- Marea Site 202 - Christchurch, New Zealand
- Marea Site 208 - Rotorua, New Zealand
- Marea Site 211 - Birkenhead, Auckland, New Zealand
- Marea Site 207 - New Lynn, Auckland, New Zealand
- Marea Site 203 - Papatoetoe, Auckland, New Zealand
- Marea Site 205 - Silverdale, Auckland, New Zealand
- Marea Site 103 - Canberra, Australian Capital Territory, Australia
- Marea Site 105 - Kanwal, New South Wales, Australia
- Marea Site 107 - Merewether, New South Wales, Australia
- Marea Site 106 - Miranda, New South Wales, Australia
- Marea Site 109 - Wollongong, New South Wales, Australia
- Marea Site 406 - Concord, Ontario, Canada
- Marea Site 403 - London, Ontario, Canada
- Marea Site 404 - Sarnia, Ontario, Canada
- Marea Site 401 - Chicoutimi, Quebec, Canada
- Marea Site 402 - Montreal, Quebec, Canada
- Marea Site 405 - Québec, Quebec, Canada
- Marea Site 407 - Québec, Quebec, Canada
- Marea Site 108 - Herston, Queensland, Australia
- Marea Site 104 - Milton, Queensland, Australia
- Marea Site 111 - Leabrook, South Australia, Australia
- Marea Site 206 - Christchurch, South Island, New Zealand
- Marea Site 204 - Ebdentown, Upper Hutt, New Zealand
- Marea Site 102 - Clayton, Victoria, Australia
- Marea Site 110 - Heidelberg Heights, Victoria, Australia
- Marea Site 113 - Hoppers Crossing, Victoria, Australia
- Marea Site 101 - Nedlands, Western Australia, Australia
- Marea Site 112 - Perth, Western Australia, Australia