February 23, 2026
Thank you for all your efforts on this study so far!
Auto injectors will begin shipping the week of 16-Feb-2026. Please prepare your site storage accordingly.
Only participants reaching week 34 should make the transition to autoinjectors until Monday, 02-Apr-2026 to allow for full rollout of the supplies. If you have a retention concern and want to roll someone at week 26/30 prior to 02-Apr-2026, escalate to your CRA and Medpace will work with you to accommodate. After 02-Apr-2026, the site will have enough inventory and processes in place to proceed with roll over to Part B.
A backup cooler is supplied to be used only if the participant forgets the study issued cooler the day of the visit. Required to be returned during the next visit. Limited supply provided, not primary mode of autoinjector transport.
Please escalate any situations to your CRA and/or Medical Monitoring Team where participants have stopped dosing and would like to resume. Restarting IP will be reviewed on a case-by-case basis.
MRL is in the final stages of programming updates for AME 5 updates, including the addition of the Malnourishment Assessment Visit. Updated documents, requisition forms/labels, and malnourishment assessment kits will be included in supplemental shipments to all sites.
You can expect to receive VK2735-302 supplies between 10-Mar-2026 – 20-Mar-2026.
Please contact the Medpace medical monitor if a malnourishment assessment is needed due to safety concerns and cannot wait for your supplemental shipment to be received. In the event of a medical monitor approved urgent assessment, MRL will require 3-5 business days to provide the appropriate kit and forms/labels.
Please see previous email for V6.0 and V7.0 of the IB for VK2735.
Please see previous email for IB memo clarifying IB versioning.
Thursday, 26Feb2026 – 4-4:45 PM ET
Friday, 27Feb2026 – 12-12:45 PM ET
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