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

ClinicalTrials.gov ID: NCT07209462

Public ClinicalTrials.gov record NCT07209462. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 5, 2026, 4:30 PM EDT

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Official title

Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of MRM-3379 in Male Participants With Fragile X Syndrome

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT07209462
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Mirum Pharmaceuticals, Inc.; Industry
Enrollment: 60 participants

Conditions and interventions

Conditions

Fragile X Syndrome

Interventions

Drug

Eligibility (public fields only)

Age range: 13 Years to 45 Years
Sex: Male
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 21, 2025
Primary completion: Sep 30, 2027
Completion: Sep 30, 2027
Last update posted: Aug 23, 2026

2025 – 2027

United States locations

U.S. sites: 15
U.S. states: 12
U.S. cities: 15

Facility	City	State	ZIP	Site status
Southwest Autism Research & Resource Center	Phoenix	Arizona	85006	Recruiting
Amnova Clinical Research, LLC	Irvine	California	92604	Recruiting
Children's Hospital of Orange County - Pediatric Subspecialty	Orange	California	92868	Recruiting
Uc Davis Mind Institute	Sacramento	California	95817	Recruiting
Children's Hospital Colorado	Aurora	Colorado	80045	Recruiting
Neurology	Miami	Florida	33136	Recruiting
Emory University - The Emory Clinic - Clifton Road	Atlanta	Georgia	30322	Recruiting
Rush University Medical Center-Clinical Operation	Chicago	Illinois	60612	Recruiting
Kennedy Krieger Institute, John Hopkins School of Medicine	Baltimore	Maryland	21205	Recruiting
Boston Children's Hospital	Boston	Massachusetts	02115	Recruiting
UMass Memorial Health	Worcester	Massachusetts	01655	Recruiting
University of Minnesota Department of Medicine	Minneapolis	Minnesota	55414	Recruiting
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	42229	Recruiting
Suburban Research Associates	Media	Pennsylvania	19063	Recruiting
Intermountain Healthcare - Park City Specialty Clinic	Salt Lake City	Utah	84108	Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07209462, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 23, 2026 · Synced Sep 5, 2026

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The complete protocol, eligibility criteria, and contact information for NCT07209462 live on ClinicalTrials.gov.

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