NCT07209462

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

Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of MRM-3379 in Male Participants With Fragile X Syndrome

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Mirum Pharmaceuticals, Inc. · Industry
• Sex: Male
• Age: 13 Years – 45 Years
• Healthy volunteers: Not accepted

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

Conditions

• Fragile X Syndrome

Interventions

Type	Name	Description
DRUG	Low dose of MRM-3379	Oral capsule
DRUG	Middle Dose of MRM-3379	Oral capsule
DRUG	High dose of MRM-3379	Oral capsule
DRUG	Placebo	Capsules matched to study drug without the active pharmaceutical ingredient
DRUG	Low dose of MRM-3379 Open-Label	Oral capsule

Timeline

• Start date: 2025-11-22
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2025-10-07
• Last updated: 2026-03-25

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study