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

Exploring MRM-3379 effects in men with Fragile X Syndrome.

Recruiting
13-45 years
Male
Phase 2

This study is exploring a medicine called MRM-3379 for males with Fragile X Syndrome (FXS), a genetic condition that causes learning challenges and developmental delays. **Participants:** Males aged 13-45, weighing at least 30 kg (about 66 pounds), and with a body mass index (BMI) between 18-36. Diagnosis requires a specific genetic marker. **Study Design:** Participants aged 16-45 will be randomly assigned to receive either the medicine or a placebo (a sugar pill) without knowing which. Those aged 13-15 will receive the medicine openly (everyone knows). The study lasts 12 weeks, and participants need to swallow tablets or capsules. **Safety and Tolerability:** The study checks if the medicine is safe, how well it is tolerated, and if it helps with FXS symptoms.

  • Participation involves 12 weeks of taking medicine and attending regular study visits.
  • Eligible participants need a consistent caregiver to help with the study.
  • Participants must be able to swallow tablets and have no other serious medical conditions.
Study details
    Fragile X Syndrome

NCT07209462

Mirum Pharmaceuticals, Inc.

20 June 2026

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