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Study of MRM-3379 for Fragile X Syndrome (BLOOM)

This study is looking at a medication called MRM-3379 for male participants with Fragile X Syndrome. Researchers want to see if MRM-3379 is safe and how well people tolerate it at different doses (low, middle, and high). They also want to see if it can help improve symptoms of Fragile X Syndrome. Some participants will receive MRM-3379, while others will receive a placebo (a capsule without active medicine). The study includes males aged 13 to 45 years old. The main goal is to track any side effects and how many people stop the study because of side effects over 12 weeks of treatment. The study is currently recruiting 60 participants.

Study design
This is a randomized, double-blind, placebo-controlled study involving 60 male participants. Some participants will receive MRM-3379, and others will receive a placebo, without knowing which they are getting.
What's involved
Participants will take an oral capsule (either MRM-3379 or placebo) for 12 weeks. The study will track side effects and withdrawals during this time.
Compensation
Not stated in the trial record.
Follow-up
The primary safety and tolerability endpoints are measured from Baseline to Week 12, which is the duration of treatment.

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NCT07209462

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

Recruiting
PHASE2Ages 13–45InterventionalTreatment
Mirum Pharmaceuticals, Inc.
~60 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:Low dose of MRM-3379Middle Dose of MRM-3379High dose of MRM-3379PlaceboLow dose of MRM-3379 Open-Label

At a glance

Recruiting sites
14 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of treatment-emergent adverse events and Withdrawal due to adverse events and withdrawal due to adverse events
Measured over Baseline to Week 12

Conditions

Fragile X Syndrome

Explore related trials

Fragile X SyndromeFMR1 Gene

Where it's being run

15 sites across 12 states
California3
Massachusetts2
Arizona1
Colorado1
Florida1
Georgia1
Illinois1
Maryland1

Who to contact

Riley Stark
[email protected]
480-351-0567
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

What this trial measures

  • Incidence and severity of treatment-emergent adverse events and Withdrawal due to adverse events and withdrawal due to adverse eventsBaseline to Week 12