Date

2026-01-19

Protocol

Protocol changed

Item Changed

Primary outcome(s)

Previous Version

1. Incidence of treatment-emergent adverse events (TEAEs). As per the completed Phase 1 Study WAL0921-01 in healthy volunteers, following adverse-events (treatment related or unrelated) are anticipated in Study WAL0921-02 are: o Headache o Dizziness o Paresthesia o Somnolence o Nausea o Diarrhoea o Vomiting 2. Efficacy assessment in the Phase 2 Study AL0921-02 involves measurement of a change in baseline proteinuria from 24-hr urine collection at the specified timepoints. Proteinuria is defined as:Ratio of urine albumin or urine protein to urine creatinine and is expressed as mg/g units 1. [At 4, 8, 12, 18, 24, 30, and 36 weeks] 2. [At 4, 8, 12, 18, 24, 30, and 36 weeks]

Next Version

Incidence of treatment-emergent adverse events (TEAEs). Baseline to Week 36