Phase 2b Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of MAR001 in Patients With Elevated Triglycerides and Remnant Cholesterol (TYDAL-TIMI 78)

Status: Recruiting
Location: See all (41) 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
NOT_YET_RECRUITING
Anniston
Marea Site 329
RECRUITING
Mobile
Arkansas
Marea Site 313
NOT_YET_RECRUITING
Little Rock
Connecticut
Marea Site 306
RECRUITING
Hamden
Florida
Marea Site 302
RECRUITING
Boca Raton
Marea Site 307
RECRUITING
Port Saint Lucie
Georgia
Marea Site 310
RECRUITING
Columbus
Marea Site 319
RECRUITING
Peachtree Corners
Illinois
Marea Site 317
RECRUITING
Park Ridge
Marea Site 325
RECRUITING
Springfield
Kentucky
Marea Site 301
RECRUITING
Louisville
Maryland
Marea Site 316
RECRUITING
Baltimore
Missouri
Marea Site 330
NOT_YET_RECRUITING
Kansas City
Marea Site 305
RECRUITING
St Louis
North Carolina
Marea Site 303
RECRUITING
Greensboro
New York
Marea Site 318
RECRUITING
New Windsor
South Carolina
Marea Site 314
RECRUITING
Greenville
Marea Site 320
RECRUITING
Little River
Tennessee
Marea Site 326
NOT_YET_RECRUITING
Memphis
Texas
Marea Site 322
NOT_YET_RECRUITING
Amarillo
Marea Site 308
RECRUITING
Mckinney
Marea Site 312
RECRUITING
San Antonio
Virginia
Marea Site 321
RECRUITING
Manassas
Washington
Marea Site 309
RECRUITING
Tacoma
Other Locations
Australia
Marea Site 103
RECRUITING
Canberra
Marea Site 108
RECRUITING
Herston
Marea Site 113
RECRUITING
Hoppers Crossing
Marea Site 105
RECRUITING
Kanwal
Marea Site 111
RECRUITING
Leabrook
Marea Site 107
RECRUITING
Merewether
Marea Site 104
RECRUITING
Milton
Marea Site 106
RECRUITING
Miranda
Marea Site 101
RECRUITING
Nedlands
Marea Site 109
RECRUITING
Wollongong
New Zealand
Marea Site 211
RECRUITING
Birkenhead
Marea Site 206
RECRUITING
Christchurch
Marea Site 209
RECRUITING
Christchurch
Marea Site 204
RECRUITING
Ebdentown
Marea Site 207
RECRUITING
New Lynn
Marea Site 208
RECRUITING
Rotorua
Marea Site 205
RECRUITING
Silverdale
Contact Information
Primary
Andrew Lane
TYDAL_info@mareatx.com
415-766-3610
Time Frame
Start Date: 2025-06-30
Estimated 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
Sponsors
Collaborators: The TIMI Study Group
Leads: Marea Therapeutics

This content was sourced from clinicaltrials.gov