Upcoming PI/CRC Teleconferences (PAV5.0 Training)  

Thursday, 26Feb2026 – 4-4:45 PM ET

Friday, 27Feb2026 – 12-12:45 PM ET

Study Reminders  

IP Storage Concerns Survey  

Please use the link below to report any concerns for IP storage your site may have regarding the autoinjector rollout. If you do NOT have any concerns, please complete the form noting no concerns.

• Responses are required as soon as possible and no later than end of the day, 06Feb2026.  

• Viking - VK2735-301 / 302 - IP Storage Concerns  – Fill out form

• 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.

Visit Guidance  

If a participant visit falls out of the visit window, every effort should be made to get them back on schedule. If however, the participant is in Part A of the study, and their subsequent weekly visit is less than 5 days away, the visit should be skipped and considered a missed visit.  If the missed visit occurs at V4, V8, V12, V16, V20, V24, V28, or V32 all missed safety assessments from that visit should be collected at the subsequent visit as unscheduled procedures.

Concomitant Medication  

A friendly reminder, participant should NOT be taking other weight loss medications while on the trial.  

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.  

IRT Quick Reference Guide V2.0  

Please see the updated IRT Quick Reference Guide V2.0 in a previously sent email.  

PCS Travel and Reimbursement Policy V3

Please see the updated PCS Travel and Reimbursement Policy V3 in a previously sent email.