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

Medical Monitoring Drop in Sessions  

Please join our medical team for a drop in discussion, open to all sites and team members to discuss challenges, provide feedback or discuss medical execution of the VANQUISH-1 & 2 protocols. We hope to see you there!

Below are the available dates and times  

• 24Mar2026 5-5:30 pm EST

• 25Mar2026 12:30-1 pm EST  

• 30Mar2026 2-2:30 pm or 5-5:30 pm EST

• 01Apr2026 3:30-4 pm EST

VK2735-302 IRT Updates  

The IRT system now allows the transition to Monthly visits at Week 26, Week 30, or Week 34. Previous supply contained Autoinjectors needed for Week 34 and beyond. Sites will begin to receive Autoinjector resupply for Week 26 and Week 30 visits in the coming week. Your site may need to wait for resupply to arrive before transitioning patients at Week 26 or Week 30.  

Per the protocol, participants may switch at Week 26, Week 30, or Week 34. If your site is waiting on supplies needed for the transition to Autoinjectors, participants may wait until Week 34 to transition.  

Updated Study Supply Request Form  

Please see the updated study supply request form previously sent via email. To ensure your request is actioned promptly please ensure to email completed forms to L.Sheffield@Medpace.com, E.adamson@Medpace.com, S.Steketee@Medpace.com, and S.Gordon@Medpace.com.

MRL Malnourishment Assessment  

To ensure your malnourishment assessment samples can be tested and resulted, please reference the QRC/Lab Manual guidance for collection and procession of samples, specifically minimum sample volumes and shipment conditions.  

Please note:

• Vitamin B1 and Vitamin C are critical frozen samples. If these are not received frozen, they cannot be analyzed.  

• Vitamin  B7 requires 2.0mL serum for testing. Samples with less volume will result as QNS.  

• Vitamin K1 requires 0.6mL plasma for testing (1.0mL preferred). Samples with less volume will result as QNS.

EDC Updates  

EDC has multiple updates which will require updated data entry on some previous forms. If any of the forms were previously completed for a participant, please go back and update data entry as applicable.

• Date of Visit (Unscheduled Visits): New fields

• Date of Visit (V7): Fasting field added to V7.  

• Only applicable if V7 was completed.

• Informed Consent/Reconsent: Protocol v5.0 added to the dropdown

• Exposure (V28 & After): New field.  

• Only applicable if participant was dosed at the visit.

• Overdose: New field

• Pharmacokinetic Blood Samples: New fields

• Only applicable if the PK sample collection was collected as part of a hypersensitivity event

• Fundoscopy: New fields

• Only applicable if fundoscopy was performed

• Only applicable if diabetic retinopathy was identified

• Eligibility and Enrollment Status: New fields for stratification

• Only applicable for randomized subjects

Site Hub Portal  

The Medpace Patient Recruitment and Retention team has officially launched the Vanquish Site Hub. This will serve as a resource to you for study information, updates, and helpful tools for your site.

On the website you will find:

• A study dashboard

• Announcements

• An introduction to PRR services

• Helpful contacts

• Frequently asked questions

Please don’t hesitate to reach out to your CRA if you have questions!  

Clarification on Data Entry Rollover   

• Please ensure you are not entering a transition date into EDC until the first monthly (Part B) auto injector visit occurs. It is important that this date matches the date of first autoinjector dose. This form is triggering the completing of ePRO diaries and if entered incorrectly will cause issues with collection of the data at correct timepoints. However, we do recommend you complete the IRT transition action from weekly to monthly a week prior to the subjects transition visit.