Clinical Trial

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

Recruiting Phase 2
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Summary
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
Protocol Amendment History 20 amendments
This ClinicalTrials.gov record has been amended 20 times since 2025-10-02; most recent amendment 2026-07-16.
Trial Details
NCT Number NCT07209462
Lead Sponsor Mirum Pharmaceuticals, Inc.
Conditions Fragile X Syndrome
Enrollment 60 participants
Start Date 2025-11-22
Primary Completion 2027-10 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-07