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Announcements and Reminders

11-May-2026 Study Update

PI/Medical Monitoring Discussion - Malnutrition Reporting. Study Procedure Reminder. Lab Processing Reminder. MRL Quick Reference Guide V8.0.

27-Apr-2026 Study Update

Review Concomitant Medication During Re-Consent. Autoinjectors. Update ePRO App. Malnutrition Assessment Updates. PI Drop-In Session Q&A Log. Updated eCRF Completion Guidelines. Site Hub Log In.

14-Apr-2026 Study Update

IP Expiry Memo Follow Up. Protocol Amendment V5.0 Materials. Vitamin Deficiency Reporting. MRL Malnourishment Assessments.

07-Apr-2026 Study Update

IP Expiry Memo Follow Up. PI Medical Monitoring Drop-In Q&A Log. Protocol Amendment V5.0 Materials. Vitamin Deficiency Reporting.

01-Apr-2026 Study Update

Protocol Clarification Letter #5. Study Protocol Clarification & Administrative Letters. IP Expiry Extension Memo. Updated Medpace Study Team List. MRL Assessment Testing Follow-Up

17-Mar-2026 Study Update

Medical Monitoring Drop-in Sessions. VK2735-302 IRT Updates. Updated Study Supply Request Form. MRL Malnourishment Assessment. EDC Updates. Site Hub Portal. Clarification on Data Entry Rollover.

11-Mar-2026 Study Update

Clarification on Malnutrition Collection and Supply Details. Clarification on Data Entry Rollover.

10-Mar-2026 Enrollment Status

The study has officially closed for screening and randomization. All subjects remaining in screening will be required to screen fail.

09-Mar-2026 Enrollment Status

Randomization remains open for VANQUISH-2. We recommend scheduling randomization visits promptly when eligibility is confirmed.

05-Mar-2026 Study Update

Enrollment Update: Randomization remains open for VANQUISH-2. Study Reminder for Daylight Savings: Ensure consideration is taken for the upcoming time change.

04-Mar-2026 Enrollment Status

Screening is now closed for VANQUISH-2. Additionally, approximately 50 randomization slots remain. Once these slots have been filled, randomization will be closed.

03-Mar-2026 Enrollment Status

At the time of this notification, there are approximately 0 screening slots available before screening will close. We expect this to happen at the end of day today or early tomorrow and will notify you once it has formally closed.

27-Feb-2026 Study Update

PI/CRC Call Follow-up. Autoinjector Injection Video. Study Reminders about the Pharmacy Manual and Advarra ICF Changes.

24-Feb-2026 Enrollment Status

We are excited to see the recent activity on screening and randomizations. There are approximately 75 screening slots remaining for VANUISH-2, which we expect to be filled in the next week.

23-Feb-2026 Study Updates

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).

20-Feb-2026 Enrollment Status

There are approximately 100 screening slots remaining for VANQUISH-2. There has been an increase in screenings and randomizations last week and we want to ensure awareness that screening will close once these slots are filled.

17-Feb-2026 Study Update

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

10-Feb-2026 Study Update

Upcoming PICRC Teleconferences (PAV5.0 raining and Important Study Updates). Enrollment Update. IP Storage. Visit Windows.

03-Feb-2026 Study Update

Upcoming PI/CRC Teleconferences (PAV5.0 Training). Enrollment Update. IP Storage Concerns Survey. Visit Guidance. Concomitant Medication. IP Dose Modification. PCS Travel and Reimbursement Policy V3.

26-Jan-2026 Study Updates

Enrollment Update. IP Storage Concerns Survey. IRT Reminder for Resuming IP After 2 Consecutive Missed Doses. ECG Acquisition and Submission Manual V5.0.

16-Jan-2026 Study Updates

VANQUISH 302 Protocol Amendment 4.0 Materials. Laboratory Manual v4.0, dated 19-Dec-2025. Study Update Recruitment: Nearing the Final Goal for Recruitment.

12-Jan-2026 Study Update

VANQUISH 301/302 Dose Dispensing Worksheet. Temperature Excursion Reporting Reminders. Update on Hypoglycemia Symptoms Diary and SMBG Data Reports. MRL Reminder. Autoinjector.

06-Jan-2026 Study Update

Enrollment Open. Sharps Container and Coolers Shipments. End of Study Stipend Clarification.

11-May-2026 Study Update

May 11, 2026

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

PI/ Medical Monitoring Discussion – Malnutrition Reporting

Meeting invitations have been sent out with varying days and times for a discussion with the Viking and Medpace medical monitoring team. This discussion will focus on malnutrition reporting and any questions you may have regarding the reporting process.  

See below the meeting options:  

  • 13-May-2026, 1:00-1:30pm EST  
  • 12-May-2026, 1:30-2:00pm EST
  • 13-May-2026, 8:30 – 9:00am EST  
  • 14-May-2026, 4:30 – 5:00pm EST  
  • 15-May-2026, 4:30 – 5:00pm EST
  • 18-May-2026, 2:30-3:00pm EST  

Please reference a previous email for the malnutrition guidance document which will be reviewed during the meetings.  

Study Procedure Reminder  

As subjects are completing their Week 12 visit, please ensure you are appropriately capturing hip and waist circumference measurements.  

If you have any questions or concerns regarding this process, please reach out to your CRA!  

Lab Processing Reminder  

Vitamin B2  

  • Vitamin B2 must be collected in a LiHep Plasma tube and have “Li Hep Plasma” written on the sample label or requisition form to be accepted. Please refer to MRL memo issued on 25-Mar-2026 for further guidance. 

MRL Quick Reference Guide V8.0

Please see a previous email for V8.0 of the Quick Reference Guide for your review and filing to your ISF.  

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