Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SB480848 EC · 1 trial · 1 indication
Blood sample for Lp-PLA2 activity was collected before administration of study medication on the sampling day. Participants were instructed to visit without meal and study medication in the morning. The study medication was administered with food following test. Baseline value was defined as the assessment done on Week 0 (Visit 2). Change from Baseline was calculated as the post-Baseline (Week 4) assessment value minus the Baseline assessment value. If either value was missing, then the change from Baseline was set to be missing. The natural logarithm (log) was used for transformation in Lp-PLA2 activity. In case of zero values, an offset of 0.0001 was added to the zero values to ensure that the log transformation was successfully applied. The log transformation was conducted on the original value and then taken the change from Baseline on that log original value, calculated as log (post-Baseline value \[week 4\]) minus log (Baseline value).
| Arm | Type | Description |
|---|---|---|
| Placebo Group | PLACEBO_COMPARATOR | Matched Placebo |
| SB480848 40mg Group | EXPERIMENTAL | SB480848 40mg/day |
| SB480848 80mg Group | EXPERIMENTAL | SB480848 80mg/day |
| SB480848 160mg Group | EXPERIMENTAL | SB480848 160mg/day |
| Name | Type | Description |
|---|---|---|
| SB480848 40mg EC Tablet | DRUG | 1 tablet once a day |
| SB480848 80mg EC Tablet | DRUG | 1 tablet once a day |
| SB480848 160mg EC Tablet | DRUG | 1 tablet once a day |
| SB480848 Placebo Tablet | DRUG | 1 tablet once a day |
Inclusion criteria: Dyslipidemic subject who is currently undergoing statin therapy and no change in lipid-lowering therapy or dose during the 4 week prior to randomization Exclusion criteria: 1. Recent (i.e.,\<6 months prior to screening) CV event and/or vascular procedure defined as: A)ST-e...
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SB480848 EC is an investigational small molecule developed by GSK plc for atherosclerosis, a cardiovascular condition in which plaque builds up inside the arteries. It is an enteric-coated 40mg tablet formulation that has been studied in dyslipidemic patients. It remains in clinical development and is not an approved medicine.
SB480848 EC was studied in patients with atherosclerosis, specifically in a Phase 2 trial that enrolled dyslipidemic patients, meaning people with abnormal lipid levels in the blood. The trial took place in Japan and was completed. No approved use has been established for SB480848 EC.
SB480848 EC is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the Phase 2 clinical study of the compound in dyslipidemic patients with atherosclerosis. The drug is an investigational asset in the company's cardiovascular pipeline.
SB480848 EC is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. Because the program has not advanced beyond Phase 2, SB480848 EC is investigational and has not been approved by the FDA or any other regulator.
SB480848 EC has been evaluated in one clinical trial, NCT00734032, titled A Phase II Clinical Study of SB-480848 in Dyslipidemic Patients. That trial was completed and enrolled 107 participants in Japan. It was randomized, double-blind, and placebo-controlled, and included adults aged 20 years and older.