September 17, 2026
Thank you for all your efforts on this study so far!
Female Participants of childbearing potential (WOCBP) must be non-pregnant and non-lactating and must use an acceptable-highly effective method of contraception (as described in Table 14) from Screening until at least 90 days after the last dose of IP.
As a reminder, the following are highly effective contraceptive methods, please ensure the participants chosen form is entered in EDC.
If you have any questions or concerns, please reach out to your CRA!
Hypoglycemia adverse events that correspond with the classification of hypoglycemia for severe hypoglycemia, OR documented symptomatic hypoglycemia, OR asymptomatic hypoglycemia should also be recorded in the CRF as AESI hypoglycemia in the dedicated AESI CRF form (see Section 8.9.5).
Your team should be receiving EDC alerts for events entered by the participant in the eDiary. If you are not receiving these alerts or have additional staff members who need to included, please contact your CRA.
Investigators should consider reducing the dose or discontinue any concomitant AHM on participants who develop persistent or recurrent unexplained hypoglycemia during the treatment period and document this concomitant medication change in the appropriate CRF. All efforts should be made to keep the participants in the study. Please contact the medical monitor team if needed.
Refer to Section 5.7.3 in the protocol for additional details
If your site needs to assign a replacement Autoinjector to a participant, please use the “Assign Replacement Study Product” action in ClinTrak IRT (see screen snippet below). The system will prompt you to enter the specific Autoinjector ID to replace. This ensures the system assigns a replacement kit of the same strength.
Do not use the “Record Unscheduled Autoinjector Assignment (Part B Participants Only)” action to assign replacement kits. This action should be reserved for unscheduled autoinjector assignments between scheduled Monthly visits due to restarting IP, dose modification, or to assign kits to participants coming in for weekly Autoinjector assignments.
Please ensure the correct sample barcode labels are being applied to all tubes ahead of shipment to MRL. Unlabeled or incorrectly labeled samples are at risk of rejection.
The Malnutrition assessment lab panel includes vitamin C testing. It is critical that Vitamin C samples are protected from light and frozen as soon as possible within 1 hour of collection, as indicated in the QRC and Lab Manual. Refer to the QRC/Lab manual for full sample processing instructions. Vitamin C degradation occurs rapidly if the sample is exposed to light or unfrozen, which can lead to erroneously low Vitamin C results.
Previously attached in an email you will find the Q&A from the drop in calls earlier this month.
.png)
