Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 is an investigational small molecule being studied for Type 2 Diabetes Mellitus and congestive heart failure. In clinical trials, it has been evaluated for its effects on gastric emptying, myocardial metabolism, myocardial function, and exercise capacity in patients with NYHA Class II/III congestive heart failure.
GSK716155 is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company has sponsored clinical trials of the drug in the United States, United Kingdom, and Japan.
GSK716155 has completed Phase 1 and Phase 2 clinical trials. The Phase 1 trials assessed safety and gastric emptying in healthy subjects and patients with Type 2 Diabetes Mellitus, while the Phase 2 trial evaluated safety and effects on myocardial metabolism and function in patients with congestive heart failure.
GSK716155 has been studied in three completed clinical trials. NCT00530309 was a Phase 1 trial in Japan with 40 patients with Type 2 Diabetes Mellitus. NCT00537719 was a Phase 1 scintigraphy study in the United States with 34 healthy subjects. NCT01357850 was a Phase 2 trial in the US and UK with 82 patients with congestive heart failure.
GSK716155 is not FDA approved. It is an investigational drug that has completed clinical trials but has not been approved for any use. The completed trials were placebo-controlled and evaluated the drug for Type 2 Diabetes Mellitus and congestive heart failure, but no approval status has been established.