Clarification on Malnutrition Collection & Supply Details  

8.9.6. Adverse Events of Special Monitoring | AESI - In the event of suspected malnourishment, the labs noted per protocol need to be collected at the current or next scheduled visit, and abnormal results can be repeated per Investigator’s discretion, encouraging focus on standard of care where deficiencies are identified.

• If labs included within malnutrition testing are required at protocol required visit, duplicate testing is not required (visit specific tests should be completed; EG: Chemistry should be completed instead of malnutrition kit)

• TEE should be recalculated as noted per protocol if a BMI ≤22 kg/m2 is reached

Weight loss of >20% - this metric is assessed at the time reconsent signature PAV5.0 and testing should follow

Weight loss of >4 kg/month- this metric is assessed moving forward following consent signature PAV5.0, it is not retroactive  

BMI ≤ 22 kg/m2 – triggers requirement for collection of malnourishment labs but can be at the next visit, including when moving to monthly visits and is not required immediately unless there are safety concerns from PI

Results from Malnutrition testing should be assessed to determine if additional follow up testing is necessary.  

Safety concerns which site takes immediate action and performed at a local laboratory necessitate a change in participant management or are considered clinically significant by the Investigator (e.g., SAE or AE or dose modification), then the results must be recorded in the CRF.

MRL has supplied sites with initial kits for the malnourishment collection.

• Resupply must be requested by site.

• Given recent order numbers, adjustment to site request can occur and please contact MRL with rationale should your full request need fulfilled.  

• Please limit orders based on confirmed participants meeting or nearing the criteria.  

• If you have concerns with when the assessment should occur, please reach out to your CRA and the medical team to support strategy.  

Sites are receiving lab kits this week (09-13Mar2026) while central IRB approval is pending.  

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.  

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