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
- Fragile X Syndrome
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Mirum Pharmaceuticals, Inc.
- Enrolment target
- 60
- Started
- 22 November 2025
- Main results due
- October 2027
- Study sites
- 18
- Registry updated
- 29 September 2026
Can you take part?
- Ages 13 years to 45 years.
- Men only.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
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
Study sites(18)
Southwest Autism Research & Resource Center
Phoenix, Arizona, United States
Recruiting
Amnova Clinical Research, LLC
Irvine, California, United States
Recruiting
Children's Hospital of Orange County - Pediatric Subspecialty
Orange, California, United States
Recruiting
Uc Davis Mind Institute
Sacramento, California, United States
Recruiting
Children's Hospital Colorado
Aurora, Colorado, United States
Recruiting
Neurology
Miami, Florida, United States
Recruiting
Emory University - The Emory Clinic - Clifton Road
Atlanta, Georgia, United States
Recruiting
Rush University Medical Center-Clinical Operation
Chicago, Illinois, United States
Recruiting
Kennedy Krieger Institute, John Hopkins School of Medicine
Baltimore, Maryland, United States
Recruiting
Boston Children's Hospital
Boston, Massachusetts, United States
Recruiting
UMass Memorial Health
Worcester, Massachusetts, United States
Recruiting
University of Minnesota Department of Medicine
Minneapolis, Minnesota, United States
Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Recruiting
Suburban Research Associates
Media, Pennsylvania, United States
Recruiting
Intermountain Healthcare - Park City Specialty Clinic
Salt Lake City, Utah, United States
Not yet recruiting
Parc Tauli Hospital Universitari
Barcelona, Spain
Recruiting
Sant Joan De Deu Barcelona Hospital
Barcelona, Spain
Recruiting
Hospital Regional Universitario de Málaga (H. Civil)
Málaga, Spain
Recruiting
Showing 18 of 18 sites. 17 of the 18 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07209462. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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