A Phase 2 Study of Albiglutide in Patients with Heart Failure

• Research type

  Research Study

• Full title

  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 non-ischemic cardiomyopathy and NYHA Class II/III congestive heart failure

• IRAS ID

  53335

• Contact name

  Stuart A Cook

• Sponsor organisation

  GlaxoSmithKline Research & Development Limited

• Eudract number

  2010-020352-59

• ISRCTN Number

  not issued

• Research summary

  Heart failure is an illness caused by inability of the heart to pump blood adequately throughout the body and is often caused by a weakening of the heart muscle. One of the factors contributing to heart muscle weakness is thought to be a reduced ability of the heart to utilise glucose as a source of energy to pump the blood. Therefore, new therapies that increase the ability of the heart to utilise glucose hold promise to improve heart function and thereby improve symptoms in patients with heart failure.GLP-1 is a hormone released in the intestine in response to food. It regulates blood glucose levels by stimulating the release of insulin which is needed to use glucose. Evidence indicates that GLP-1 may also play a more direct role in heart function. Studies have shown that proteins similar to GLP-1 can improve heart function by increasing glucose utilisation in the heart muscle. Albiglutide is a protein similar to GLP-1. The purpose of this study is to look at the effect of different doses of albiglutide and placebo (dummy drug) on glucose uptake, heart pumping efficiency and exercise performance in patients with heart muscle weakness and heart failure over a 3 month period.Participants will be randomly assigned to receive either placebo, or one of three doses of albiglutide which will be injected weekly under the skin. They will have an equal chance of being assigned to any group. Participants will undergo a screening visit, at least 12 study visits and a follow-up visit. During these visits the procedures that will be undertaken include blood sampling, heart imaging, exercise testing, ECGs, physical examination, measurement of vital signs and health status.This study is sponsored by GlaxoSmithKline. Approximately 120 patients will participate in the UK and USA.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  10/H0707/54

• Date of REC Opinion

  29 Jul 2010

• REC opinion

  Further Information Favourable Opinion