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A study to evaluate the safety of MRM-3379 in men with Fragile X Syndrome

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What is this study about?

This study focuses on individuals with Fragile X Syndrome, a genetic condition that can cause various developmental and cognitive challenges. The research aims to evaluate the safety and how well the body tolerates a new experimental drug called MRM-3379.

Participants in this study will be assigned to receive either MRM-3379, which is taken as a hard capsule by oral use, or a placebo. This is a double-blind study, meaning that neither the participants nor the researchers know who is receiving the active medication or the placebo during the course of the trial. The study will monitor how the body processes the drug and observe any side effects that may occur.

Who Can Join the Study?

  • You must be a male between the ages of 13 and 45 years old.
  • You must have a diagnosis of Fragile X Syndrome, which is a genetic condition, and have a specific genetic test result showing 200 or more CGG repetitions (this refers to a repeated pattern of DNA code in your genes).
  • You must weigh at least 30 kilograms.
  • Your Body Mass Index (a measure of body weight relative to height) must be at least 18 but less than 36.
  • You or your legal representative must be willing and able to sign an informed consent form, which is a document that explains all the details and risks of the study before you agree to join.
  • If you cannot provide consent yourself, a legally authorized representative (a person allowed by law to make decisions for you) must sign for you, and you must provide assent (your personal agreement to participate).
  • You must have a regular caregiver (a person who looks after you) who is willing and able to be with you consistently.
  • You must be able to swallow tablets or capsules (medicine in pill form).

Who Cannot Join the Study?

  • You cannot participate if you have a medical condition (a health problem or illness) other than Fragile X Syndrome or issues directly related to it that could make participating in this study more dangerous for you.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Hgykpcms Ubrdrwlxhzhtd Rwdgjrfu Dn Mvmauj Malaga Spain
Pxum Tjrsa Hkcdygab Uqumoedvdbod Sabadell Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not yet recruiting
01.05.2026

Trial locations

MRM-3379 is an experimental medication taken by mouth in capsule form. This study is testing how safe and well the body tolerates this drug in men with Fragile X Syndrome.

Investigated diseases:

Fragile X Syndrome – This is a genetic condition caused by a change in a specific gene on the X chromosome. It primarily affects how the brain develops and functions. The condition often leads to various developmental delays and challenges with learning. Individuals may also experience differences in social behavior and communication skills. As the person grows, these developmental and behavioral characteristics typically persist throughout their life.

Trial ID:
2025-523738-21-00
Protocol code:
​​ENV-202​
NCT ID:
NCT07209462
Trial Phase:
Therapeutic exploratory (Phase II)

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