Thank you for all your efforts on this study so far!
Study Reminders
Upcoming PI/CRC Teleconferences (PAV5.0 Training)
Thursday, 26Feb2026 – 4-4:45 PM ET
Friday, 27Feb2026 – 12-12:45 PM ET
Enrollment Update
The 302 study has approximately 225 enrollment slots left.
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.
- 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, participants should NOT be taking other weight loss medications while on the trial.
IP Dose Modification
The release of the new protocol amendment includes updated guidance on dose modifications for two different subsets of participants.
- Participants with a BMI <24
- Participants with GI tolerability issues at week 10
This guidance for implementing changes in IRT is below for easy reference. Should you have a participant meeting these criteria please follow the process outlined below:
Participants with a BMI ≤24
- Please title email: Viking VK2735-302: BMI Dose Modification: Participant ID
- Please include the study number, the Participant number, and the Participants visit status (i.e. on-site, scheduled
- Once the above is sent, an IRT correction request should be submitted at your earliest convenience
- Please include the participant number and request to down-titrate for BMI threshold
- The Medpace team will respond to your email with confirmation that you can proceed with dose dispensation.
Participant with GI tolerability issues at week 10
- Steps 1, 2, and 3 have been completed per Dose Modification section of the protocol and participant is planning to down-titrate at V12/Week 10
- Please title email: Viking VK2735-302: GI Tolerability Dose Modification: Participant ID
- Please include the study number, the participant number, and the participant visit status (i.e. on-site, scheduled)
- Once the above is sent, an IRT correction request should be submitted at your earliest convenience
- Please include the participant number and request to down-titrate at V12/Week 10
- The Medpace team will respond to your email with confirmation that you can proceed with dose dispensation.
- Steps for the subsequent week (s):
- Prior to V13/Week 11, follow above steps to confirm if participant will remain on lower tolerated dose or re-challenge dose at V13/Week 11
- If participant does not re-challenge at V13/Week 11, follow above steps prior to V14/Week 12 to confirm action to take at V14/Week 12 (remain on lower tolerated dose or re-challenge dose)
- If participant does not re-challenge at V14/Week 12, follow above steps prior to V15/Week 13 to confirm action to take at V15/Week 13 (re-challenge dose or remain on lower tolerated dose for remainder of treatment)
PCS Travel and Reimbursement Policy V3
Please see the updated PCS Travel and Reimbursement Policy V3 previously sent via email.
.png)
