Discussing this with biotech/pharma sponsors and building some dose escalation buffer into a protocol to keep the participant in the study and manage these AEs (when possible) can be a good strategy to keep participants in the trial & improve their experience
For reference, in the Rybelsus PIONEER Phase 3 trial for T2D, Rybelsus achieved A1C reductions in the range of 1.0 to 1.1%
Catalase Inhibits Ionizing Radiation-Induced Apoptosis in Hematopoietic Stem and Progenitor Cells
Discontinuation rates ranged from 11% to 24%, most often due to gastrointestinal intolerance
Supports memory and attention Made with hypoallergenic, vegan ingredients Acetyl-l-Carnitine is a building block for proteins that helps the body produce energy, as well as stabilize cell membranes to support memory, emotional health and cognitive function
Maintenance: Dose may be increased in increments of 2.5 mg every 4 weeks as needed