Announcements and Reminders

10-Feb-2026 Study Update

February 10, 2026

Thank you for all your efforts on this study so far!

Upcoming PI/CRC Teleconferences (PAV5.0 Training and Important Study Updates)  

Thursday, 26Feb2026 – 4-4:45 PM ET

Friday, 27Feb2026 – 12-12:45 PM ET

Study Reminders  

IP Storage  

Thank you to all those who have completed the survey. We would kindly request if you noted concerns, you contact your CRA if a strategy has not yet been implemented to support study supplies being provided as past of the auto injector roll out process.

  • Responses if you have not already completed can be provided here:  
  • As a reminder, IRT will begin to dispense on a 30-day supply strategy. This will result in sites receiving IP on a once-a-week basis.
  • Participant coolers will begin shipping the week of 16-Feb-2026.

BMI Down titration

Please note, the VK2735-301 IRT now has a new action to “Record Dose Modification due to BMI Level”. Sites should use this action if they wish to permanently down-titrate a participant due to BMI <=24.0 kg/m2. The sites should record this action BEFORE recording the participant’s visit/drug assignment.

After a site performs a BMI down-titration, at the next visit with drug assigned, if prompted, site should select the option to “Stay on assigned dose”. System will automatically assign the new dose. They should only select the options for down-titration if related to tolerability.

For participants in which the IRT Team manually down-titrated due to BMI <=24 (while the IRT was being reprogrammed), sites do not need to retroactively record the action. We have updated the IRT settings for the participants to note that they were permanently down-titrated due to BMI.  

Visit Windows

When scheduling participant visits, please take a proactive approach. All sites have access to the ClinTrak participant's visit grid which includes projected visit windows within IRT. Should you have questions on how to access this please reach out to your CRA.