drugset / Trial / NCT07209462

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

NCT07209462 ↗

Phase 2 Recruiting 60 enrolled Mirum Pharmaceuticals, Inc.
RandomizedParallel-groupDouble-blindTreatment

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

Timeline

Start
2025-11-22
Primary completion
2027-10
Completion
2027-10

Drugs

EvaluationDrugModalityDoseRoute
Subject MRM-3379 Unknown — Oral

Indications