Phase 2b Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of MAR001 in Patients With Elevated Triglycerides and Remnant Cholesterol (TYDAL-TIMI 78)
Status: Active_not_recruiting
Location: See all (54) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The primary objective of the study is to evaluate the effect of MAR001 compared to placebo on levels of the TG and RC in adults with elevated TG and RC.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Elevated fasting TGs and RC
• Elevated nonfasting TGs and RC
• 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 diet through duration of study
• Stable drug regimen (if relevant) prior to screening visit and no planned changes during screening or trial participation
Locations
United States
Alabama
Marea Site 328
Anniston
Marea Site 329
Mobile
Arkansas
Marea Site 313
Little Rock
Connecticut
Marea Site 306
Hamden
Florida
Marea Site 302
Boca Raton
Marea Site 307
Port Saint Lucie
Georgia
Marea Site 310
Columbus
Marea Site 319
Peachtree Corners
Illinois
Marea Site 317
Park Ridge
Marea Site 325
Springfield
Kentucky
Marea Site 301
Louisville
Maryland
Marea Site 316
Baltimore
Missouri
Marea Site 330
Kansas City
Marea Site 305
St Louis
North Carolina
Marea Site 303
Greensboro
Marea Site 315
Winston-salem
New York
Marea Site 304
Great Neck
Marea Site 318
New Windsor
South Carolina
Marea Site 314
Greenville
Marea Site 320
Little River
Tennessee
Marea Site 326
Memphis
Texas
Marea Site 322
Amarillo
Marea Site 308
Mckinney
Marea Site 312
San Antonio
Virginia
Marea Site 321
Manassas
Washington
Marea Site 309
Tacoma
Other Locations
Australia
Marea Site 103
Canberra
Marea Site 102
Clayton
Marea Site 110
Heidelberg Heights
Marea Site 108
Herston
Marea Site 113
Hoppers Crossing
Marea Site 105
Kanwal
Marea Site 111
Leabrook
Marea Site 107
Merewether
Marea Site 104
Milton
Marea Site 106
Miranda
Marea Site 101
Nedlands
Marea Site 112
Perth
Marea Site 109
Wollongong
Canada
Marea Site 401
Chicoutimi
Marea Site 406
Concord
Marea Site 403
London
Marea Site 402
Montreal
Marea Site 405
Québec
Marea Site 407
Québec
Marea Site 404
Sarnia
New Zealand
Marea Site 211
Birkenhead
Marea Site 206
Christchurch
Marea Site 209
Christchurch
Marea Site 204
Ebdentown
Marea Site 207
New Lynn
Marea Site 203
Papatoetoe
Marea Site 208
Rotorua
Marea Site 205
Silverdale
Time Frame
Start Date: 2025-06-30
Completion Date: 2026-12
Participants
Target number of participants: 216
Treatments
Experimental: MAR001 Dose 1
Subcutaneous injection
Experimental: MAR001 Dose 2
Subcutaneous Injection
Experimental: MAR001 Dose 3
Subcutaneous Injection
Related Therapeutic Areas
Sponsors
Collaborators: The TIMI Study Group
Leads: Marea Therapeutics