Announcements and Reminders

24-Jul-2026 Study Update

July 24, 2026

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

Advarra System Updates

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:

Vanquish 3

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.  

Discontinuation of Study Treatment in IRT

  • 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. 

Post Auto-Injector Survey

Please fill out this brief survey, linked here:  

Viking VANQUISH Studies - Post Auto-Injector Survey – Fill out form

To provide feedback and pain points on auto-injector transition. As a reminder, during conversations with participants regarding the use of auto-injectors, please be sure to highlight that self-injection is how VK2735 will be presented in the commercial setting. Getting comfortable with auto-injector use, having the ability to ask questions, and having access to training videos all while under very close medical care of the study team is a benefit of continuing participation

PEth Testing

PEth testing only occurs at unscheduled visits, meaning that there is not a specific designated kit. Please use a tube from extra supply kit when conducting this test.  

Subject eDiary  

It is important to remind subjects to complete their subject diary when dosing AND when they do not dose.  

If you have any questions or concerns, please reach out to your CRA.  

Site Communications reminder  

It is important to remember to include your site CRA on any relevant communications. This ensures your request is sent to the correct team and is actioned in a timely manner.  

MRL Study Reminders  

Ensure your site is using the most up to date version of Malnourishment Assessment requisition forms and sample labels.  

The use of the outdated forms/labels may lead to Vitamin B2 sample rejection if “LiHep Plasma” is not indicated on the form or tube. No written information is needed if you’re using the updated forms/labels. The current forms/labels version names the Vitamin B2 sample as “Vitamin B2”. The outdated forms/labels names the Vitamin B2 ample as “Alq 1: Vitamin B2”.  Please discard all outdated forms/labels.

Ensure each sample shipped to MRL has a barcoded label affixed to the tube. Sending unlabeled tubes to MRL increases the risk of sample rejection. Please contact the MRL helpdesk ahead of shipment if for some reason you do not have the label you need on site.  

Review the QRC/Lab Manual for samples requiring protection from light in amber vials. If any of these samples requiring light protection are received in clear vials, the testing will not be able to be performed.  

Vitamin B7 and requires 2.0mL of serum for testing. Vitamin K1 requires 1.0mL of plasma for testing. Please ensure these aliquot tubes are adequately filled to ensure testing can be resulted.

If PEth testing is needed, please use a unscheduled visit form/label and use a tube from your Kit XS to perform this collection.  

Only use Kit MAL for full Malnourishment Assessment visits. If you only need to recheck a single result and the tubes required are not within your Kit XS, you can order these tubes by writing them at the bottom of your resupply form.  

If malnourishment assessment samples are to be collected at a scheduled visit that collects chemistry per SoA, both the chemistry and malnourishment chemistry samples should be collected as the scheduled testing is not identical on each sample.