Actively Recruiting
Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM)
Led by Mirum Pharmaceuticals, Inc. · Updated on 2026-05-11
60
Participants Needed
15
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, 13 to 45 years old (inclusive)
- Weight at least 30 kg and BMI between 18 and 36 kg/m2 (inclusive) at screening
- Diagnosis of Fragile X Syndrome confirmed by molecular genetic testing with 200 or more CGG repetitions
- Able to perform the PVT and ORRT of the NIH Toolbox Cognition Battery
- Have a consistent caregiver willing and able to be present regularly with the participant
- Able to swallow tablets or capsules
- Willing and able to provide signed informed consent or assent; if unable, a legally authorized representative must consent and the participant must assent if applicable
You will not qualify if you...
- History of or current medical condition other than Fragile X Syndrome and related issues that increases risk from study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Southwest Autism Research & Resource Center
Phoenix, Arizona, United States, 85006
Actively Recruiting
2
Amnova Clinical Research, LLC
Irvine, California, United States, 92604
Actively Recruiting
3
Children's Hospital of Orange County - Pediatric Subspecialty
Orange, California, United States, 92868
Not Yet Recruiting
4
Uc Davis Mind Institute
Sacramento, California, United States, 95817
Not Yet Recruiting
5
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Not Yet Recruiting
6
Neurology
Miami, Florida, United States, 33136
Not Yet Recruiting
7
Emory University - The Emory Clinic - Clifton Road
Atlanta, Georgia, United States, 30322
Actively Recruiting
8
Rush University Medical Center-Clinical Operation
Chicago, Illinois, United States, 60612
Actively Recruiting
9
Kennedy Krieger Institute, John Hopkins School of Medicine
Baltimore, Maryland, United States, 21205
Not Yet Recruiting
10
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
11
UMass Memorial Health
Worcester, Massachusetts, United States, 01655
Actively Recruiting
12
University of Minnesota Department of Medicine
Minneapolis, Minnesota, United States, 55414
Not Yet Recruiting
13
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 42229
Not Yet Recruiting
14
Suburban Research Associates
Media, Pennsylvania, United States, 19063
Actively Recruiting
15
Intermountain Healthcare - Park City Specialty Clinic
Salt Lake City, Utah, United States, 84108
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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