drugset / Trial / NCT01357850

A Multi-center, Placebo-controlled Study to Evaluate the Safety of GSK716155 and Its Effects on Myocardial Metabolism, Myocardial Function, and Exercise Capacity in Patients With NYHA Class II/III Congestive Heart Failure

NCT01357850

Phase 2 Completed 82 enrolled GlaxoSmithKline
RandomizedParallel-groupTriple-blindBasic science

Summary

This exploratory proof of concept study will be conducted in patients with stable New York Heart Association (NYHA) Class II-III heart failure. The focus of the efficacy endpoints is to test the hypothesis that GSK716155 administration will increase glucose uptake and utilization in the myocardium, resulting in increased myocardial efficiency and increased exercise capacity. A positive result, defined as either statistically significant effects on one or more of the efficacy endpoints or as an overall signal suggesting a clinically relevant effect on myocardial physiology, would provide evidence for potential progression into further development in a chronic heart failure population.

Timeline

Start
2010-09-15
Primary completion
2012-09-18
Completion
2012-09-18

Drugs

EvaluationDrugModalityDoseRoute
Subject albiglutide Peptide 3.75 mg
Subject albiglutide Peptide 15 mg
Subject albiglutide Peptide 30 mg