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Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM)
Sponsor: Mirum Pharmaceuticals, Inc.
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
Official title: Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of MRM-3379 in Male Participants With Fragile X Syndrome
Key Details
Gender
MALE
Age Range
13 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-11-22
Completion Date
2027-10
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
Low dose of MRM-3379
Oral capsule
Middle Dose of MRM-3379
Oral capsule
High dose of MRM-3379
Oral capsule
Placebo
Capsules matched to study drug without the active pharmaceutical ingredient
Low dose of MRM-3379 Open-Label
Oral capsule
Locations (15)
Southwest Autism Research & Resource Center
Phoenix, Arizona, United States
Amnova Clinical Research, LLC
Irvine, California, United States
Children's Hospital of Orange County - Pediatric Subspecialty
Orange, California, United States
Uc Davis Mind Institute
Sacramento, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Neurology
Miami, Florida, United States
Emory University - The Emory Clinic - Clifton Road
Atlanta, Georgia, United States
Rush University Medical Center-Clinical Operation
Chicago, Illinois, United States
Kennedy Krieger Institute, John Hopkins School of Medicine
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
UMass Memorial Health
Worcester, Massachusetts, United States
University of Minnesota Department of Medicine
Minneapolis, Minnesota, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Suburban Research Associates
Media, Pennsylvania, United States
Intermountain Healthcare - Park City Specialty Clinic
Salt Lake City, Utah, United States