5 results
The aim of this study is determine the efficacy and safety of Metformin as a weight reducing drug in the euglykemic, obese paediatric population.
The objective of this pivotal study is to assess the PK and PD as well as safety and tolerability of RP103 compared to Cystagon® in patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support the registration…
- To assess the pharmacokinetic profile of cysteamine base after single dose administration of the new sustained-release cysteamine bitartrate (PO-001) to healthy volunteers, in comparison with Cystagon® and Procysbi®.- To collect safety/…
Part A: healthy volunteers (n=up to 15)Primary/safety objective: - To assess the safety, tolerability and pharmacokinetics of a single IV dosage of OTL78 Secondary objective: - To assess the pharmacodynamics of OTL78 by measuring the temporal…
Primary objectiveTo confirm the superiority of liraglutide at the maximum tolerated dose (0.6 mg, 1.2 mg or 1.8 mg) versus placebo when added to metformin with or without basal insulin treatment in controlling glycaemia in children and adolescents (…