Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Simvastatin · 5 trials · 3 indications
Median percent change from LOV111858 (NCT00903409) End-of-Treatment (double-blind study, Week 8) to the Month 4 visit of LOV111818 (open-label extension trial)
| Arm | Type | Description |
|---|---|---|
| Simvastatin + Lovaza® ("Non-switchers") | EXPERIMENTAL | Open label Simvastatin + Lovaza® (omega-3-acid ethyl esters) NOTE: this group was originally assigned to Simvastatin + Lovaza® in the double-blind trial, hence in this open-label extension, they are termed "Non-switchers" |
| Simvastatin + Lovaza® ("Switchers") | EXPERIMENTAL | Open label Simvastatin + Lovaza® (omega-3-acid ethyl esters) NOTE: this group was originally assigned to Simvastatin + placebo in the double-blind trial, hence in this open-label extension, they are termed "Switchers" |
| Simvastatin | ACTIVE_COMPARATOR | Simvastatin + placebo |
| Simvastatin + Lovaza | EXPERIMENTAL | Simvastatin + Lovaza (omega-3-acid ethyl esters) |
| simvastatin plus albiglutide | EXPERIMENTAL | A single dose of 80mg simvastatin on Day 1 followed by 5 weekly doses of subcutaneous albiglutide followed by a single dose of 80mg simvastatin on Day 38. |
| Single Sequence | EXPERIMENTAL | Simvastatin will be administered on Day 1 and Day 10. Rosuvastatin will be administered on Day 3 and Day 12. GSK1292263 will be administered on Days 6 to 14. |
| Cohort 1: Atorvastatin | EXPERIMENTAL | single dose session with Atorvastatin with PK samples collected up to 72h post dose, then 14 days repeat dose session with SB649868 with Atorvastatin single dose co-administered on day 8 (same time as SB649868) and on day 12 (2 hours before SB649868). |
| Cohort 2: Simvastatin | EXPERIMENTAL | single dose session with Simvastatin with PK samples collected up to 24h post dose, then 14 days repeat dose session with SB649868 with Simvastatin single dose co-administered on day 12 (same time as SB649868) and on day 14 (2 hours before SB649868). |
| Name | Type | Description |
|---|---|---|
| Simvastatin + Lovaza® (omega-3-acid ethyl esters) | DRUG | Open-label Simvastatin + Lovaza® (omega-3-acid ethyl esters) \[formerly known as Omacor\] |
| Simvastatin | DRUG | Simvastatin |
| Simvastatin + Lovaza | DRUG | Simvastatin + Lovaza (omega-3-acid ethyl esters) |
| simvastatin plus albiglutide | BIOLOGICAL | A single dose of 80mg simvastatin on Day 1 followed by 5 weekly doses of subcutaneous albiglutide followed by a single dose of 80mg simvastatin on Day 38. |
| Rosuvastatin | DRUG | Rosuvastatin 10mg (single dose) on Days 3 and 12. |
| GSK1292263 | DRUG | GSK1292263 300mg BID Days 6 to 14. |
| Atorvastatin | DRUG | 20mg single dose given alone and coadministered with SB649868 on day 8 and 12 of the 14-day repeat dose period. |
| SB649868 | DRUG | 20mg daily given for 14 days. |
For LOV111818/OM6X - Subjects were included in the study if they had met all relevant inclusion/exclusion criteria prior to and throughout the double-blind Study LOV111858/OM6 and completed Study LOV111858/OM6 to Week 8. FYI - entry criteria for LOV111818/OM6 (double-blind study) Inclusion Criteri...
Simvastatin is a small molecule drug that acts as an HMGCR inhibitor. It is being studied by GSK plc in Phase 1 clinical development for type 2 diabetes mellitus, hypertriglyceridemia, and sleep disorders. It has also been evaluated in combination with other agents such as albiglutide and omega-3-acid ethyl esters.
Simvastatin targets HMGCR, also known as HMG-CoA reductase. As an inhibitor of this enzyme, it interferes with the mevalonate pathway. This mechanism is the basis for its investigation in metabolic conditions such as hypertriglyceridemia and type 2 diabetes mellitus.
Simvastatin is being developed by GSK plc, which trades under the ticker GSK. The company has sponsored clinical trials of simvastatin both as a single agent and in combination with other drugs, including albiglutide and Lovaza (omega-3-acid ethyl esters).
Simvastatin is in Phase 1 clinical development according to the available data. It has not been approved by the FDA for the indications listed here. The Phase 1 trials have been completed, and no active trials are currently reported.
Simvastatin has been studied in completed clinical trials including NCT01299597, a Phase 1 drug interaction study in sleep disorders; NCT01147692, a Phase 1 interaction study with albiglutide in type 2 diabetes; NCT01101568, a Phase 1 interaction study with GSK1292263 in type 2 diabetes; and NCT00903409, a Phase 3 study in hypertriglyceridemia.