Clinical Research Alert: Real World Study of Male Fertility Following Risdiplam Treatment

Researchers at Genentech Inc. are seeking adult males treated with risdiplam (Evrysdi) for spinal muscular atrophy (SMA) to participate in an observational study (MARLIN) to assess the effects of treatment on fertility. Risdiplam is FDA-approved for treating SMA in pediatric and adult patients. The current study aims to better understand the fertility experiences of men with SMA who are taking or have taken risdiplam while trying to conceive.

The study

The MARLIN study does not include a new intervention or procedures such as laboratory tests or doctor visits. It is an observational study that consists of a series of questionnaires to be completed remotely, through a designated app. Participants enrolled in the study will be required to provide data via a questionnaire at the beginning of the study (baseline) and then annually for 3 years. There is also an option for the sexual partner/surrogate/gestational carrier of the enrolled participant to complete a baseline and annual questionnaire for 3 years. The questionnaires will include questions on the following topics: (1) demographic information, including age and race/ethnicity; (2) information about how long the participant has been on or was taking risdiplam; (3) medical history, medication, and lifestyle; (4) sexual history; (5) fertility journey, including tests and treatment the participant has undergone during attempts to conceive a child. For more information, please visit the study registry at the following link.

Study criteria

To be eligible for the MARLIN research study, individuals must meet the following inclusion criteria:

• Males with SMA between 18 and 50 years of age, who are taking or have taken risdiplam, and are trying to conceive a child or have previously conceived a child after taking risdiplam

Individuals may not be eligible to participate if they meet the following exclusion criteria:

• Males who are using/used donor sperm for conception
• Males who are using/used their own cryopreserved sperm that was not exposed to risdiplam for conception

Interested in participating?

A stipend will be provided to study participants for their time and effort.

People interested in participating can contact the study team by phone: 1-855-662-7546 (1-855-6MARLIN), email: MARLINStudy@ubc.com, or by visiting the study website at the following link: https://marlinstudy.com/