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Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study sites: 16 to 18
  2. Study sites: 15 to 16
    • Eligibility criteria expanded, about 7 words
  3. Site details revised at 1 of 15 sitesv24
  4. Site details revised at 1 of 15 sitesv23
  5. Site details revised at 2 of 15 sitesv22
Show 20 earlier versionsHide 20 earlier versions
  1. Site details revised at 1 of 15 sitesv21
  2. Site contacts updated at 1 of 15 sitesv20
  3. Site details revised at 1 of 15 sitesv19
  4. Site details revised at 1 of 15 sitesv18
  5. Site details revised at 1 of 15 sitesv17
  6. Site details revised at 2 of 15 sitesv16
  7. Site contacts updated at 1 of 15 sitesv15
  8. Site details revised at 1 of 15 sitesv14
  9. Site details revised at 2 of 15 sitesv13
  10. Site details revised at 4 of 15 sitesv12
  11. Site contacts updated at 9 of 15 sites
    • Study title expanded, about 1 word
    v11
  12. Study sites: 5 to 15v10
  13. Study sites: 4 to 5v9
  14. Start date changed from estimate of Dec 2025 to Nov 22, 2025v8
  15. Study sites: 5 to 4v7
  16. Site details revised at 1 of 5 sitesv6
  17. Site details revised at 1 of 5 sitesv5
  18. Site details revised at 1 of 5 sitesv4
  19. Site contacts updated at 1 of 5 sitesv3
  20. Study title shortened, about 2 wordsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is a multicenter, double-blind, randomized, placebo-controlled study to assess the safety and tolerability of 3 doses of MRM-3379 in male participants with Fragile X Syndrome ages 16 to 45 (inclusive). In addition, a parallel cohort of participants ages 13 to \<16 will receive open-label MRM-3379. All participants will participate for 12 weeks of treatment. The study is also intended as a proof-of-concept investigation to evaluate whether MRM-3379 can improve FXS symptoms
Trial Details
NCT Number NCT07209462
Lead Sponsor Mirum Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Fragile X Syndrome
Related terms Fragile X Syndrome
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov