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.

17-Feb-2026 Study Update

February 17, 2026

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

Study Reminders

Initial Auto Injector & Supply Shipments

Auto injectors are currently being shipped the week of 16-Feb-2026. As referenced previously, please reach out with any storage concerns.

https://forms.office.com/Pages/ResponsePage.aspx?id=ue8sTGxNtkiwcQO2J4WmyNQK8ufblIVGg2tFifkd4t1UNkhXS1hGOE1TTEU3NDNJU0wxVTU5MEszUi4uParticipant coolers are currently being distributed to sites starting the week of 16-Feb-2026. The coolers are labeled for the VANQUISH program and not study specific, you will receive enough coolers for 301 and 302 participants as applicable for your site.

BMI Dose Modifications Under PA5

Once your site is approved under PA5, please ensure to consider and follow the updated BMI dose modifications as stated below.

BMI ≤24 kg/m²: Even in the absence of any intolerable symptoms, Investigators could down-titrate the participant at the next study visit. Please refer to PA5 for further details.

BMI ≤22 kg/m²: The recommended energy intake should be recalculated with no kcal deficit for the remainder of the trial, and the participant must be down-titrated to 7.5 mg weekly if not previously done at BMI ≤24 kg/m². Additional laboratory assessments must also be collected once BMI reaches 22 kg/m². Please refer to PA5 for further details.

MRL Reminders

When submitting resupply orders for MRL supplies, it is the site’s responsibility to monitor site stock levels and only request kits which will be used in the next 3 months. Resupply requests are reviewed prior to shipment; large requests that do not align with enrollment numbers are rejected. Sites should not place orders for kits more than 3 months in advance. MRL guarantees a 3-month minimum expiry date on resupply orders.

MRL has noted a recent increase in ambient/refrigerated samples being received frozen. Please ensure your site is following the winter sample shipment instructions. If needed, the memo can be found on the ClinTrak Lab documents portal.

Upcoming PI/CRC Teleconferences (PAV5.0 Training and Important Study Updates)

Thursday, 26-Feb-2026 – 4-4:45 PM ET

Friday, 27-Feb-2026 – 12-12:45 PM ET