Familial Hypertriglyceridemia Clinical Trials

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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 (55) 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 TG 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

• 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

Locations
United States
Alabama
Marea Site 328
ACTIVE_NOT_RECRUITING
Anniston
Marea Site 329
ACTIVE_NOT_RECRUITING
Mobile
Arkansas
Marea Site 313
ACTIVE_NOT_RECRUITING
Little Rock
Connecticut
Marea Site 306
ACTIVE_NOT_RECRUITING
Hamden
Florida
Marea Site 302
RECRUITING
Boca Raton
Marea Site 307
RECRUITING
Port Saint Lucie
Georgia
Marea Site 310
ACTIVE_NOT_RECRUITING
Columbus
Marea Site 319
RECRUITING
Peachtree Corners
Illinois
Marea Site 317
ACTIVE_NOT_RECRUITING
Park Ridge
Marea Site 325
RECRUITING
Springfield
Kentucky
Marea Site 301
ACTIVE_NOT_RECRUITING
Louisville
Maryland
Marea Site 316
ACTIVE_NOT_RECRUITING
Baltimore
Missouri
Marea Site 330
ACTIVE_NOT_RECRUITING
Kansas City
Marea Site 305
RECRUITING
St Louis
North Carolina
Marea Site 303
ACTIVE_NOT_RECRUITING
Greensboro
Marea Site 315
ACTIVE_NOT_RECRUITING
Winston-salem
New York
Marea Site 304
ACTIVE_NOT_RECRUITING
Great Neck
Marea Site 318
ACTIVE_NOT_RECRUITING
New Windsor
South Carolina
Marea Site 314
ACTIVE_NOT_RECRUITING
Greenville
Marea Site 320
RECRUITING
Little River
Tennessee
Marea Site 326
RECRUITING
Memphis
Texas
Marea Site 322
ACTIVE_NOT_RECRUITING
Amarillo
Marea Site 308
ACTIVE_NOT_RECRUITING
Mckinney
Marea Site 312
ACTIVE_NOT_RECRUITING
San Antonio
Virginia
Marea Site 321
ACTIVE_NOT_RECRUITING
Manassas
Washington
Marea Site 309
ACTIVE_NOT_RECRUITING
Tacoma
Other Locations
Australia
Marea Site 103
ACTIVE_NOT_RECRUITING
Canberra
Marea Site 102
RECRUITING
Clayton
Marea Site 110
ACTIVE_NOT_RECRUITING
Heidelberg Heights
Marea Site 108
ACTIVE_NOT_RECRUITING
Herston
Marea Site 113
ACTIVE_NOT_RECRUITING
Hoppers Crossing
Marea Site 105
ACTIVE_NOT_RECRUITING
Kanwal
Marea Site 111
RECRUITING
Leabrook
Marea Site 107
ACTIVE_NOT_RECRUITING
Merewether
Marea Site 104
RECRUITING
Milton
Marea Site 106
ACTIVE_NOT_RECRUITING
Miranda
Marea Site 101
RECRUITING
Nedlands
Marea Site 112
RECRUITING
Perth
Marea Site 109
ACTIVE_NOT_RECRUITING
Wollongong
Canada
Marea Site 401
RECRUITING
Chicoutimi
Marea Site 406
RECRUITING
Concord
Marea Site 403
ACTIVE_NOT_RECRUITING
London
Marea Site 402
RECRUITING
Montreal
Marea Site 405
RECRUITING
Québec
Marea Site 407
RECRUITING
Québec
Marea Site 404
RECRUITING
Sarnia
New Zealand
Marea Site 211
RECRUITING
Birkenhead
Marea Site 202
ACTIVE_NOT_RECRUITING
Christchurch
Marea Site 206
RECRUITING
Christchurch
Marea Site 209
ACTIVE_NOT_RECRUITING
Christchurch
Marea Site 204
ACTIVE_NOT_RECRUITING
Ebdentown
Marea Site 207
ACTIVE_NOT_RECRUITING
New Lynn
Marea Site 203
ACTIVE_NOT_RECRUITING
Papatoetoe
Marea Site 208
ACTIVE_NOT_RECRUITING
Rotorua
Marea Site 205
RECRUITING
Silverdale
Contact Information
Primary
Matty Hughes
TYDAL_info@mareatx.com
415-766-3610
Time Frame
Start Date: 2025-06-30
Estimated Completion Date: 2028-04
Participants
Target number of participants: 316
Treatments
Experimental: MAR001 Dose 1 (Part A)
Subcutaneous injection
Experimental: MAR001 Dose 2 (Part A)
Subcutaneous Injection
Experimental: MAR001 Dose 3 (Part A)
Subcutaneous Injection
Experimental: MAR001 Dose 4 (Part B)
Subcutaneous Injection
Sponsors
Collaborators: The TIMI Study Group
Leads: Marea Therapeutics

This content was sourced from clinicaltrials.gov