Announcements and Reminders

11-Mar-2026 Study Update

Clarification on Data Entry Rollover. Please ensure you are not entering a transition date into EDC until the first monthly auto injector visit occurs.

10-Mar-2026 Study Update

Clarification on Malnutrition Collection and Supply Details. Adverse Events of Special Monitoring.

04-Mar-2026 Study Update

VK2735-301 IRT Updates. Site FAQ/Discussion Guide. Daylight Savings. Advarra ICF Changes.

27-Feb-2026 Study Update

PI/CRC Call Follow-Up. Autoinjector Injection Video. Pharmacy Manual. Advarra ICF Changes.

23-Feb-2026 Study Update

Auto Injector Roll Out & Supply Details. Drug Holiday and Restarting IP. MRL Reminders. Investigator's Brochure. Upcoming PI/CRC Teleconferences (PAV5.0 Training and Important Study Updates)

17-Feb-2026 Study Update

Initial Auto Injector & Supply Shipments BMI Dose Modifications Under PA5. MRL Reminders. Upcoming PI/CRC Teleconferences (PAV5.0 Training and Important Study Updates).

10-Feb-2026 Study Update

Upcoming PI/RC Teleconferences (PAV5.0 Training and Important Study Updates). IP Storage. BMI Down Titration. Visit Windows.

03-Feb-2026 Study Update

Upcoming PI/CRC Teleconferences. IP Storage Concerns Survey. Visit Guidance. Concomitant Medication. BMI Down Titration. IRT Quick Reference Guide V2.0. PCS Travel and Reimbursement Policy V3.

26-Jan-2026 Study Update

IP Autoinjector Storage Concerns Survey. IRT Reminder for Resuming IP After 2 Consecutive Missed Doses.

16-Jan-2026 Study Update

VANQUISH 301 Protocol Amendment 4.0 Materials. Laboratory Manual v4.0, dated 19-Dec-2025. Retention Reminders. Autoinjector Transition.

12-Jan-2026 Study Update

VANQUISH 301/302 Dose Dispensing Worksheet. Temperature Excursion Reporting Reminders. MRL Reminder. Autoinjector.

06-Jan-2026 Study Update

Study Reminders. Sharps Containers and Coolers Shipments. End of Study Stipend Clarification. PI/CRC Call Follow-up.

12-Jan-2026 Study Update

January 12, 2026

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

Study Reminders

VANQUISH 301/302 Dose Dispensing Worksheet

To support quality and consistency for dosing completion, the Dose Dispensing Worksheet (previously attached in an email) has been developed for site use. This worksheet can be used as a tool to support focus and attention when completing dosing visits for your enrolled subjects.

Temperature Excursion Reporting Reminders

Please ensure you are following the requirements of the Pharmacy Manual when reporting temperature excursions for review. The Temperature Excursion Reporting Form was attached previously via email for quick reference.

MRL Reminder

When responding to MRL queries, please do not include the subject's full date of birth. Only the year of birth and age is required to resolve the query. Our data management team is not able to save responses for record when it contains protected health information. Please reach out to the MRL PM team with any further questions.

Autoinjector

Please be advised, as sites transition subjects to autoinjectors, IRT will begin to dispense on a 30-day supply strategy. This will result in sites receiving IP on a once-a-week basis.