7 results
The primary objectives of this study is:* To determine the safety and tolerability of rhHNS via ascending doses administered via a surgically implanted intrathecal drug device (IDDD) once monthly for 6 months, in patientswith MPS IIIA.The secondary…
The primary objective of this study is to assess the potential clinical efficacy of HGT-1410administered via a surgically implanted IDDD in patients with MPS IIIA. Efficacy will bemeasured as a meaningful amelioration in the progression of cognitive…
To evaluate the feasibility, safety and efficacy related endpoints for the Fractyl Revita System for the treatment of uncontrolled type 2 diabetes.
Phase 1 (0 - 24 Weeks) Objective:To study the effect of DMR on glycemic and mechanistic endpoints24 weeks post-procedure in subjects with T2D.Phase 2 (24 - 48 Weeks) Objective:To study the effect of DMR on glycemic endpoints for assessment…
Primary Objective(s): To evaluate long-term safety in patients with mucopolysaccharidosis type IIIA disease (MPS IIIA or Sanfilippo Type A) who received HGT-1410Secondary Objective(s):To evaluate:• The long-term cognitive function as measured by the…
The main objective of this pilot study is to evaluate the efficacy of the Duodenal Mucosal Resurfacing procedure combined with GLP-1 administration and lifestyle intervention in subjects with insulindependent type 2 diabetes. Study success is…
The primary objective of this study is to evaluate the efficacy and durability of KBP-5074 in reducing SBP.The primary endpoint for efficacy is change in seated trough cuff SBP from baseline to Week 12.The second key endpoint for durability is…