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

RecruitingPhase 2Ages 13 Years - 45 YearsMaleMirum Pharmaceuticals, Inc.
NCT07209462 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Willing and able to provide signed informed consent/assent. Where local regulations permit inclusion of participants deemed unable to provide informed consent, a legally authorized representative must provide informed consent on the participant's behalf, and the participant must provide assent if applicable. * Male, 13-45 years of age (inclusive) * Weight ≥30 kg and BMI between 18 and 36 kg/m2 (inclusive) at the screening visit * Diagnosis of FXS with a molecular genetic ≥200 CGG repetitions . * Able to perform the PVT and ORRT of the NIH-TCB * Have a consistent caregiver(s) who is willing and able to be present regularly and reliably with the participant * Able to swallow tablets or capsules Exclusion Criteria: History of or current medical condition other than FXS and related issues that would place the participant at higher risk from study participation
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What it tests

  • Low dose of MRM-3379
  • Middle Dose of MRM-3379
  • High dose of MRM-3379
  • Placebo
  • Low dose of MRM-3379 Open-Label
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Where

18 sites
Southwest Autism Research & Resource Center
Phoenix, United States
Amnova Clinical Research, LLC
Irvine, United States
Children's Hospital of Orange County - Pediatric Subspecialty
Orange, United States
Uc Davis Mind Institute
Sacramento, United States
Children's Hospital Colorado
Aurora, United States
Neurology
Miami, United States
Emory University - The Emory Clinic - Clifton Road
Atlanta, United States
Rush University Medical Center-Clinical Operation
Chicago, United States

…and 10 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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