ACTIVE_NOT_RECRUITING

Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol

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Conditions

HypertriglyceridemiaMAR001Remnant CholesterolTYDALTIMI-78

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-30
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT07028749

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Elevated fasting TGs and RC
  2. * Elevated nonfasting TGs and RC
  3. * Fasting LDL-C ≥ 50 mg/dL (≥ 1.29 mmol/L) and ≤ 130 mg/dL (≤ 3.36 mmol/L)
  4. * Willingness to provide informed consent and comply with the intervention and all study assessments
  5. * Stable diet for a minimum of 3 months prior to screening and with no plans to change diet through duration of study
  6. * Stable drug regimen (if relevant) prior to screening visit and no planned changes during screening or trial participation
  1. * Acute or chronic liver disease
  2. * TG concentration ≥880mg/dl
  3. * History of type 1 diabetes mellitus or history of diabetic ketoacidosis
  4. * Newly diagnosed T2DM
  5. * Participants with known active hepatitis A, B, or C
  6. * Uncontrolled hypothyroidism
  7. * Any condition that prevents the participant from complying with study procedures

Contacts and Locations

Study Locations (Sites)

Marea Site 328
Anniston, Alabama, 36207
United States
Marea Site 329
Mobile, Alabama, 36608
United States
Marea Site 313
Little Rock, Arkansas, 72204
United States
Marea Site 306
Hamden, Connecticut, 06517
United States
Marea Site 302
Boca Raton, Florida, 33434
United States
Marea Site 307
Port Saint Lucie, Florida, 34952
United States
Marea Site 310
Columbus, Georgia, 31904
United States
Marea Site 319
Peachtree Corners, Georgia, 30092
United States
Marea Site 317
Park Ridge, Illinois, 60068
United States
Marea Site 325
Springfield, Illinois, 62702
United States
Marea Site 301
Louisville, Kentucky, 40213
United States
Marea Site 316
Baltimore, Maryland, 21229
United States
Marea Site 330
Kansas City, Missouri, 64151
United States
Marea Site 305
St Louis, Missouri, 63110
United States
Marea Site 304
Great Neck, New York, 11021
United States
Marea Site 318
New Windsor, New York, 12553
United States
Marea Site 303
Greensboro, North Carolina, 27405
United States
Marea Site 315
Winston-Salem, North Carolina, 27104
United States
Marea Site 314
Greenville, South Carolina, 29607
United States
Marea Site 320
Little River, South Carolina, 29566
United States
Marea Site 326
Memphis, Tennessee, 38119
United States
Marea Site 322
Amarillo, Texas, 79124
United States
Marea Site 308
McKinney, Texas, 75071
United States
Marea Site 312
San Antonio, Texas, 78229
United States
Marea Site 321
Manassas, Virginia, 20109
United States
Marea Site 309
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: Marea Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-30
Study Completion Date2026-12

Study Record Updates

Study Start Date2025-06-30
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Hypertriglyceridemia
  • MAR001
  • Remnant Cholesterol
  • TYDAL
  • TIMI-78

Additional Relevant MeSH Terms

  • Hypertriglyceridemia