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Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM)
NCT07209462 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Placebo
- DRUG Low dose of MRM-3379
- DRUG Middle Dose of MRM-3379
- DRUG High dose of MRM-3379
- DRUG Low dose of MRM-3379 Open-Label
Study Locations (15)
California
- Amnova Clinical Research, LLC — Irvine
- Children's Hospital of Orange County - Pediatric Subspecialty — Orange
- Uc Davis Mind Institute — Sacramento
Massachusetts
- Boston Children's Hospital — Boston
- UMass Memorial Health — Worcester
Arizona
- Southwest Autism Research & Resource Center — Phoenix
Colorado
- Children's Hospital Colorado — Aurora
Florida
- Neurology — Miami
Georgia
- Emory University - The Emory Clinic - Clifton Road — Atlanta
Illinois
- Rush University Medical Center-Clinical Operation — Chicago
Maryland
- Kennedy Krieger Institute, John Hopkins School of Medicine — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-11-22 |
| Est. Completion | 2027-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07209462
The ClinicalTrials.gov registry entry for NCT07209462 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mirum Pharmaceuticals, which has 14 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Fragile X Syndrome appearing as the primary indexed condition, and to 5 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07209462 reports 15 study locations spanning 12 distinct geographic areas — top geographies include California, Massachusetts, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07209462 about?
NCT07209462 is a clinical study titled "Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM)". 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 ...
What is the current status of trial NCT07209462?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2025-11-22. Estimated completion is 2027-10.
What conditions does trial NCT07209462 study?
This clinical trial studies the following conditions: Fragile X Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07209462?
The interventions under investigation include: Placebo (DRUG), Low dose of MRM-3379 (DRUG), Middle Dose of MRM-3379 (DRUG), High dose of MRM-3379 (DRUG), Low dose of MRM-3379 Open-Label (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07209462?
This trial is sponsored by Mirum Pharmaceuticals, which has 14 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07209462 being conducted?
This trial has 15 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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