Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Diabetes drug metformin tested for fragile x symptoms

NCT ID NCT03862950

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether metformin, a common diabetes medication, can help improve language, behavior, and weight problems in people with fragile X syndrome. 125 participants aged 6 to 35 took either metformin or a placebo for 4 months. Researchers measured changes in language skills and behavior to see if the drug made a difference.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Metformin
What this could lead to
If it works, this could point toward a treatment to improve language and behavior and reduce obesity in people with fragile X syndrome.
What could go wrong
This is a phase 2 trial with only 125 participants, so results may not be conclusive. Metformin is a diabetes drug, and its benefits for fragile X syndrome are not yet proven.

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

125 people

The number who actually took part.

Started

May 2019

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

6 to 35 years

Sex

Anyone

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: * Subject has Fragile X syndrome with a molecular genetic confirmation of the full FMR1 mutation (\>200 CGG repeats) or the other loss of function mutations of the FMR1 gene (SNVs and deletions of the gene). * Subject is a male or non-pregnant, non-lactating female age 6 through 35 years, inclusive. * Subjects who are capable of becoming pregnant must use an acceptable method of birth control for the duration of the study. Acceptable forms of birth control include abstinence (only for subjects who are not sexually active), intrauterine devices in place for at least 3 months, oral contraceptives, surgical sterilization, or adequate barrier methods. * Subject must have a caregiver (parent, guardian, or other legally authorized representative) who is willing to participate in the whole study. * Subject and caregiver are able to attend the clinic regularly and reliably. * Subject and/or subject's caregiver is able to understand, read, write and speak English or French fluently to complete study-related materials. * For subjects who are not their own legal guardian, subject's caregiver is able to understand and sign an informed consent to participate in the study. * The use of concomitant medication must be stable, in terms of dose and dosing regimen, for at least 4 weeks prior to Screening and must remain stable during the period between first visit (Screening) and the commencement of the study; every effort should be made to maintain stable regimens of allowed concomitant medications from the time of commencement of double-blind study medication until the last study assessment. * Behavioral/educational treatments must be stable for 4 weeks prior to first visit (Screening) and must remain stable during the period between Screening and the commencement of randomized double-blind study medication. * 10\. Overall age equivalent is not higher than 13 and IQ is not higher than 85, as assessed at Screening on the Leiter-III, and subject must speak at least occasional 3-word phrases. Exclusion Criteria: * Families that are not cooperative and will not follow through with the demands of this study. * Subject has a life-threatening medical problem or other major systemic illness that compromises health or safety and/or would interfere with this study. * Age younger than 6 or older than 35 years. * History of intolerable adverse events with metformin. * Current or recent metformin treatment (within the past 4-months). * BMI inferior to 2 standard deviations below the mean for age using the World Health Organization scale. * Serum creatinine \> 1.4 mg/dl (female) or \> 1.5 mg/dl (male). * History of metabolic acidosis or a condition with lactic acidosis. * Severe Vitamin B12 deficiency. * Pregnancy at screening or unwillingness to use acceptable method of birth control, if applicable. * Age equivalent higher than 13 or IQ higher than 85 on the Leiter-III at Screening.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Fra(X) syndrome are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • CHU Sainte-Justine

    Montreal, Quebec, H3T 1C5, Canada

  • University of Alberta

    Edmonton, Alberta, T6G 2E1, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.