July 2, 2026
Thank you for all your efforts on this study so far!
The Medpace and Viking medical monitoring team will be hosting drop-in sessions. The dates and times are listed below. Please ensure you are responding to the meeting invitation with your site’s planned attendance of Accepted, Declined, or Tentative.
As you may know, Advarra is transitioning to the new CIRBI next-generation system, effective the week of 13-Jul-2026. While they work through this update, you should receive several emails from Advarra providing further instructions to activate your new account. Please be on the lookout for notices from the following Advarra email addresses:
We appreciate any questions for additional insight into participating in start up activities for the VK2735-303 study. We are internally evaluating and will be in touch with more information in late July 2026.
If a participant is off IP but continuing in the study, the sites should use the “Report Permanent Discontinuation of Study Treatment” action in IRT. That way we don’t continue to send IP for the patient.
If a participant is skipping dosing, sites should record the visits with no drug assigned, so IRT captures the number of consecutive doses missed. The system will continue to send IP for the patient until they are discontinued.
If a patient has been off IP for a long time, and site doesn’t know if they will resume, it probably would make sense to report permanent discontinuation of IP in IRT. If they are approved to restart drug in the future, we can reverse the permanent discontinuation of study drug status and provide next steps for the correct visit will restart at.
.png)
