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Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol

Study acronym: TYDAL-TIMI 78
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 3 months later Jul 2026 → Nov 2027
See other at-risk trials from Marea Therapeutics

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 54 to 55v9
  2. Primary completion pushed from Jul 2026 to Nov 2027v8 Show 8 more changesShow less
    • Enrollment reopened
    • Enrollment increased: 216 → 316 participants
    • Study completion pushed from Dec 2026 to Apr 2028
    • Trial arms changed: 3 → 4
    • Eligibility criteria expanded, about 62 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description expanded, about 165 words
    • Site details revised at 54 of 54 sites
  3. Eligibility criteria revised
    • Secondary endpoints: 1 to 4
    v7
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 54 of 54 sites
    v6
  5. Study sites: 41 to 54v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 31 to 41v4
  2. Study sites: 25 to 31v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 2 to 25
    • Start date changed from estimate of Jun 2025 to Jun 30, 2025
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07028749
Lead Sponsor Marea Therapeutics
Collaborators: The TIMI Study Group
Conditions
(from sponsor)		 Hypertriglyceridemia
Related terms Hypertriglyceridemia
Enrollment 316 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov