madman
Super Moderator
The OraGrowtH212 trial is a global study involving 80 patients in four arms, testing three different doses of a new drug compared to the standard dose of growth hormone. The study aims to measure catchup growth over an extended period, with promising interim results indicating comparable growth to moderate growth hormone deficiency patients.
Highlights:
- Global trial with 80 patients in four arms
- Testing three doses of new drug compared to standard growth hormone
- Safety profile of the drug is outstanding
- End point is catchup growth at six months annualized
- Topline results expected in the fourth quarter
- Robust data set includes patients on drug for up to two years
- Promising interim results showed comparable growth to moderate growth hormone deficiency patients
- Study highly drisked through predictive enrichment markers strategy
- Patients selected based on specific growth hormone and igf1 levels
- Imbalance in growth hormone arm due to younger patients, but overall good outcome predicted
