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NCT07209462 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Fragile X Syndrome, sponsored by Mirum Pharmaceuticals.

Recruiting
Registry status
Phase 2
Development phase
60
Enrollment target
15
Study locations

NCT07209462 is a Phase 2 study of Fragile X Syndrome that is actively recruiting participants, run by Mirum Pharmaceuticals. The registered enrollment target is 60 participants, below the 98-participant average among 16 other Fragile X Syndrome trials with a reported enrollment target (39% lower). The trial reports 15 study locations across 12 states.

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The verdict

NCT07209462, a Phase 2 study of Fragile X Syndrome, is actively recruiting participants, sponsored by Mirum Pharmaceuticals.

RECRUITING
Registry status
Phase 2
Development phase
60 participants
Enrollment target
15
Study locations

Study 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

Conditions Studied

Fragile X Syndrome

Interventions

  • DRUG Placebo
  • DRUG Low dose of MRM-3379
  • DRUG Middle Dose of MRM-3379
  • DRUG High dose of MRM-3379
  • DRUG Low dose of MRM-3379 Open-Label

Study Locations (15)

California

  • Amnova Clinical Research, LLC - Irvine
  • Children's Hospital of Orange County - Pediatric Subspecialty - Orange
  • Uc Davis Mind Institute - Sacramento

Massachusetts

  • Boston Children's Hospital - Boston
  • UMass Memorial Health - Worcester

Arizona

  • Southwest Autism Research & Resource Center - Phoenix

Colorado

  • Children's Hospital Colorado - Aurora

Florida

  • Neurology - Miami

Georgia

  • Emory University - The Emory Clinic - Clifton Road - Atlanta

Illinois

  • Rush University Medical Center-Clinical Operation - Chicago

Maryland

  • Kennedy Krieger Institute, John Hopkins School of Medicine - Baltimore

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2025-11-22
Est. Completion 2027-10
Phase Phase 2

Sponsor

Mirum Pharmaceuticals

28 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07209462

The ClinicalTrials.gov registry entry for NCT07209462 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 98-participant average among 16 other Fragile X Syndrome trials with a reported enrollment target (39% lower). The listed sponsor is Mirum Pharmaceuticals, which has 28 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Fragile X Syndrome appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.

NCT07209462 reports 15 study locations spanning 12 distinct geographic areas - top geographies include California, Massachusetts, Arizona.

Frequently Asked Questions

What is clinical trial NCT07209462 about?

NCT07209462 is a clinical study titled "Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM)". 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 ...

What is the current status of trial NCT07209462?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2025-11-22. Estimated completion is 2027-10.

What conditions does trial NCT07209462 study?

This clinical trial studies the following conditions: Fragile X Syndrome.

What interventions are being tested in trial NCT07209462?

The interventions under investigation include: Placebo (DRUG), Low dose of MRM-3379 (DRUG), Middle Dose of MRM-3379 (DRUG), High dose of MRM-3379 (DRUG), Low dose of MRM-3379 Open-Label (DRUG).

Who is sponsoring clinical trial NCT07209462?

This trial is sponsored by Mirum Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07209462 being conducted?

This trial has 15 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.