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Also known as GSK716155 for injection
GSK716155 · 3 trials · 2 indications
FDG-PET imaging was performed at Baseline and Week 13 to assess myocardial glucose uptake. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on analysis using a mixed effects analysis of variance (ANOVA) model, fitting terms for treatment, visit and interaction of treatment and visit, with participants as random effects.
MVO2 was estimated by measuring the rate of myocardial clearance of 11C-activity which represents overall myocardial oxidative flux through the TCA cycle. Cardiac work was measured by echocardiography and cardiac efficiency index was calculated as work (by echocardiography) divided by MVO2. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on analysis using a mixed effects ANOVA model, fitting terms for treatment, visit and interaction of treatment and visit, with participants as random effects.
Peak VO2 was measured at Baseline and Week 13. Participants performed a maximal exercise test limited by dyspnea or fatigue on a cycle ergometer. After a rest period, the workloads were increased in a step fashion by 25 watts every 3 minutes. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on analysis using a mixed effects ANOVA model, fitting terms for treatment, visit and interaction of treatment and visit, with participants as random effects.
| Arm | Type | Description |
|---|---|---|
| GSK716155 (3.75mg) | EXPERIMENTAL | GSK716155 (3.75mg) |
| GSK716155 (15mg) | EXPERIMENTAL | GSK716155 (15mg) |
| GSK716155 (30mg) | EXPERIMENTAL | GSK716155 (30mg) |
| GSK716155-matched placebo | PLACEBO_COMPARATOR | GSK716155-matcued placebo |
| GSK716155 | ACTIVE_COMPARATOR | albiglutide subcutaneous injection |
| placebo | PLACEBO_COMPARATOR | placebo injection |
| Subjects receiving GSK716155 + placebo | EXPERIMENTAL | Eligible subjects will receive GSK716155 with doses of 15 milligrams once a week, 30 milligrams once a week, 50 milligrams biweekly or 100 milligrams once every four weeks. Subjects will also receive placebo. |
| Name | Type | Description |
|---|---|---|
| GSK716155 | DRUG | GSK716155 |
| Placebo | DRUG | Placebo |
| GSK716155 for injection | DRUG | GSK716155 will be available with doses of 15 milligrams once a week, 30 milligrams once a week, 50 milligrams biweekly or 100 milligrams once every four weeks. |
Inclusion Criteria: * Chronic dilated cardiomyopathy of ischemic or non-ischemic origin * Clinically stable on optimal therapies for at least 3 months prior to screening/baseline visit. * Left ventricular ejection fraction greater than or equal to 40% as assessed by any measurement in the previous ...
GSK716155 has been studied in type 2 diabetes mellitus and in congestive heart failure. Clinical trials evaluated it in patients with NYHA Class II or III congestive heart failure and in patients with type 2 diabetes, including a gastric emptying study in healthy subjects. It remains an investigational agent and is not an approved treatment.
GSK716155 is developed by GSK plc, which trades under the ticker GSK. The company sponsored the clinical studies of the compound in type 2 diabetes and congestive heart failure.
GSK716155 is in Phase 1 development overall, with completed Phase 1 studies in type 2 diabetes. One completed trial, NCT01357850, was listed as Phase 2 in congestive heart failure. The program has no active trials, and GSK716155 is investigational rather than approved.
GSK716155 has been evaluated in completed trials including NCT01357850, a placebo-controlled Phase 2 study of safety, myocardial metabolism, myocardial function and exercise capacity in NYHA Class II/III congestive heart failure, NCT00537719, a Phase 1 gastric emptying scintigraphy study in healthy subjects, and NCT00530309, a Phase 1 study in type 2 diabetes in Japan.
Yes. GSK716155 for injection is an alternative name for GSK716155, the small molecule developed by GSK plc. Both names refer to the same investigational compound studied in type 2 diabetes mellitus and congestive heart failure.
Across the completed studies, 82 patients were enrolled in the Phase 2 congestive heart failure trial NCT01357850, 34 healthy subjects in the Phase 1 gastric emptying study NCT00537719, and 40 patients in the Phase 1 type 2 diabetes study NCT00530309. The Phase 2 trial was randomized and placebo-controlled.