12 results
Primary objective adults:To demonstrate the superiority of iptacopan (200 mg b.i.d.) compared to placebo in reducing proteinuria at 6 months of treatment.The primary clinical question of interest is:What is the effect of iptacopan vs. placebo on log…
Primary objectiveTo confirm the effect on glycaemic control of once weekly insulin icodec in combination with insulin aspart, in subjects with T1D. This includes comparing the difference in change from baseline in HbA1c between once weekly insulin…
The primary objective is to demonstrate the superiority of ziltivekimab 15 mg s.c. once-monthly in reducing the risk of MACE (as defined by the primary endpoint) compared to placebo, both added to standard of care, in participants with established…
The overall objective is to assess efficacy, safety, pharmacokinetic (PK), pharmacodynamics (PD) of avalglucosidase alfa in male and femaleparticipants less than or equal to 6 months of age with IOPD.
Primary objectives:- To confirm the haemostatic effect of Mim8 as treatment prophylaxis for adult and adolescent patients with haemophilia A with or without inhibitors.Secondary objectives:- To investigate safety of Mim8 prophylaxis in adults and…
Primary objective: To investigate the safety of Mim8 prophylaxis in children with haemophilia A with or without FVIII inhibitors.Secondary objectives• To investigate the efficacy of Mim8 prophylaxis in children with haemophilia A with or without…
Primary objectiveTo investigate the effects of semaglutide s.c. 2.4 mg once-weekly on physical function, symptoms and body weight compared with placebo, both added to standard of care, in subjects with obesity-related HFpEF and T2D.Secondary…
Primary objectiveTo confirm the superiority of oral semaglutide versus placebo on the change in cognition and function in subjects with MCI or mild dementia, both of the Alzheimer*s type.Secondary objectivesTo compare the effects of oral semaglutide…
Primary objectiveTo confirm the superiority of oral semaglutide versus placebo on the change in cognition and function in subjects with MCI or mild dementia, both of the Alzheimer*s type.Secondary objectivesTo compare the effects of oral semaglutide…
Primary objective:Assess the efficacy of rilzabrutinib in participants with atopic dermatitis (AD)Secondary objectives: * Assess the efficacy of rilzabrutinib at different time points* Assess the safety of rilzabrutinib
Primary objective:To demonstrate superiority of three dose levels of oral NNC0385-0434 versus placebo on percent change in LDL-C from baseline to week 12 in patients with established ASCVD or ASCVD risk on maximally tolerated statin dose and other…
The primary objective is to evaluate the long-term safety and tolerability of iptacopan in eligible participants. The primary clinical question of interest is: what is the long-term safety and tolerability of iptacopan in IgAN participants including…