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New drug trial hopes to ease fragile x symptoms in boys and men

NCT ID NCT07209462

Symptom relief Sponsor: Mirum Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 7 times

Summary

This study tests an experimental drug called MRM-3379 in males aged 13 to 45 with Fragile X Syndrome. The goal is to see if the drug is safe and can improve symptoms like learning and behavior. Participants will take the drug or a placebo for 12 weeks. The study is currently recruiting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

13 to 45 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

fragile X syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fragile X syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    16 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Amnova Clinical Research, LLC

    RECRUITING

    Irvine, California, 92604, United States

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Children's Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Orange County - Pediatric Subspecialty

    RECRUITING

    Orange, California, 92868, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 42229, United States

  • Emory University - The Emory Clinic - Clifton Road

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Intermountain Healthcare - Park City Specialty Clinic

    NOT_YET_RECRUITING

    Salt Lake City, Utah, 84108, United States

  • Kennedy Krieger Institute, John Hopkins School of Medicine

    RECRUITING

    Baltimore, Maryland, 21205, United States

    Contact Email: •••••@•••••

  • Neurology

    RECRUITING

    Miami, Florida, 33136, United States

  • Rush University Medical Center-Clinical Operation

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Sant Joan De Deu Barcelona Hospital

    RECRUITING

    Barcelona, 08950, Spain

  • Southwest Autism Research & Resource Center

    RECRUITING

    Phoenix, Arizona, 85006, United States

  • Suburban Research Associates

    RECRUITING

    Media, Pennsylvania, 19063, United States

  • UMass Memorial Health

    RECRUITING

    Worcester, Massachusetts, 01655, United States

  • Uc Davis Mind Institute

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Minnesota Department of Medicine

    RECRUITING

    Minneapolis, Minnesota, 55414, United States

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