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RecruitingPhase 2

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

Mirum Pharmaceuticals, Inc. · NCT07209462

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 13–45 · Men only
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
60
US sites recruiting
14
Study start
November 22, 2025
Record last updated
September 29, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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

Being studied: Low dose of MRM-3379; Middle Dose of MRM-3379; High dose of MRM-3379; Placebo; Low dose of MRM-3379 Open-Label

Conditions: Fragile X Syndrome

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Southwest Autism Research & Resource Center

    Phoenix, AZ 85006

    Site contact: Riley Stark · 480-351-0567 · rstark@autismcenter.org

  • Amnova Clinical Research, LLC

    Irvine, CA 92604

    Site contact: Maggie Wang · 949-358-7447 · maggie@amnovaresearch.com

  • Children's Hospital of Orange County - Pediatric Subspecialty

    Orange, CA 92868

    Site contact: Adrienne Moore · 714-288-7456 · Adrienne.Moore@choc.org

  • Uc Davis Mind Institute

    Sacramento, CA 95817

    Site contact: Melissa Heys · 916-703-0301 · meheys@health.ucdavis.edu

  • Children's Hospital Colorado

    Aurora, CO 80045

    Site contact: Nicole Tartaglia · 720-777-6895 · Nicole.Tartaglia@childrenscolorado.org

  • Neurology

    Miami, FL 33136

    Site contact: Dr. Barbara Coffey · 305-243-2759 · bjc134@miami.edu

  • Emory University - The Emory Clinic - Clifton Road

    Atlanta, GA 30322

    Site contact: Robin Vinson · 404-778-8533 · robin.vinson@emory.edu

  • Rush University Medical Center-Clinical Operation

    Chicago, IL 60612

    Site contact: Lorelai Konen · 312-942-2815 · Lorelai_Konen@rush.edu

  • Kennedy Krieger Institute, John Hopkins School of Medicine

    Baltimore, MD 21205

    Site contact: Kennedy Krieger · 443-923-3850 · ResearchTrials@KennedyKrieger.org

  • Boston Children's Hospital

    Boston, MA 02115

    Site contact: Michelle Coughlin · 857-218-3842 · michelle.Coughlin@childrens.harvard.edu

  • UMass Memorial Health

    Worcester, MA 01655

    Site contact: Taylor Merk · 774-455-4119 · Taylor.merk@umassmed.edu

  • University of Minnesota Department of Medicine

    Minneapolis, MN 55414

    Site contact: Rachel Floersch · 612-626-8424 · Floer013@umn.edu

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, OH 42229

    Site contact: Hannah Sachs · 513-803-1150 · Hannah.Sachs@cchmc.org

  • Suburban Research Associates

    Media, PA 19063

    Site contact: Naya Square · 610-891-9024 · Nsquare@suburbanresearch.com

Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM) (NCT07209462) | Bored Studies