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

Lifestyle Guidance and Q&A  

Thank you to those who have joined our first two options. If you have yet to join, please join our last option:  

Option 3 – Monday, 12Oct2026 2-2:45 PM ET

Protocol Amendment V6.0 (PAV6.0) Site Training

Please be on the lookout for upcoming invites regarding PAV6.0 site training. We will have three options targeting the first week of Nov2026.  

Data Management Update – Participant Discontinuation  

Please see instruction below regarding reason for participant discontinuation.

• Review dropdown options for Primary Reason of Discontinuation closely.

• When possible, the option with the most specificity should be chosen over “Withdrawal by Subject”, “Physician Decision”, or “Other”.

• Example: If primary reason is for perceived lack of efficacy, consider selecting “Lack of Efficacy” instead of “Withdrawal by Subject”

• Similar consideration should be given for options like “Met Protocol Defined Minimum BMI”, “Goal Weight Met”, etc.

Study Procedure Reminders – Vitals  

Please see below section 8.2 of the protocol regarding rest requirements prior to completing other study procedures. The study expectation is participant will sit for 5 minutes prior to vital signs in a quiet setting without distractions. During this time other study procedures such as ePROs or mental health questionnaires should not be completed by the participant.  

If you have any further questions, please feel free to reach out to your site’s assigned CRA.  

Updated Study Team Listing   

Please review the updated study team listing previously distributed via email. Please ensure this is filed to your site ISF binder.  

Study Supply Request Form V5.0   

Please see V5.0 of the 302-study supply resupply request form previously distributed via email.   

• Please file this to your site ISF binder, and ensure to use this form when requesting supplies, email this completed form to the Medpace Project Coordinator: L.Sheffield@medpace.com; E.Fox2@medpace.com; E.Szucsik@medpace.com; S.Gordon@medpace.com.