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Announcements and Reminders

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.

27-Feb-2026 Study Update

February 27, 2026

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

PI/CRC Call Follow-up

In a previously distributed email, you will find the slides from the PI/CRC call this week. Thank you again for your attendance and participation. We will distribute the minutes with Q&A soon.  

Autoinjector Injection Video

Study Reminders

Pharmacy Manual

Please see previous email for the V5.0 of the Pharmacy Manual along with its supporting logs.  

  • Part B Autoinjector Subject Accountability Log
  • Part B Autoinjector Master Accountability Log
  • AI Compliant Intake Form
  • Temperature Excursion Form V3.0

Advarra ICF Changes

We have seen and are aware of multiple versions of the consent form being released in a rapid period due to errors made by Advarra during IRB finalization of the updated consent corresponding with PAV5.0. Medpace is working to obtain additional guidance from Advarra on reconsenting requirements and additional details are forthcoming. Thank you for your patience and understanding. 

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