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Also known as Lapaquistat acetate, Lapaquistat
Lapaquistat and fenofibrate · 11 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| Lapaquistat Acetate 50 mg QD + Simvastatin | EXPERIMENTAL | - |
| Lapaquistat Acetate 100 mg QD + Simvastatin | EXPERIMENTAL | - |
| Simvastatin | ACTIVE_COMPARATOR | - |
| Lapaquistat Acetate 100 mg QD | EXPERIMENTAL | - |
| Lapaquistat Acetate 100 mg QD + Added Therapy | EXPERIMENTAL | - |
| Lapaquistat Acetate 50 mg QD + Rosuvastatin | EXPERIMENTAL | - |
| Lapaquistat Acetate 100 mg QD + Rosuvastatin | EXPERIMENTAL | - |
| Rosuvastatin | ACTIVE_COMPARATOR | - |
| Lapaquistat Acetate 50 mg QD | EXPERIMENTAL | (and stable lipid-lowering therapy) |
| Stable Lipid-lowering therapy | ACTIVE_COMPARATOR | - |
| Lapaquistat Acetate 100 mg QD + Ezetimibe | EXPERIMENTAL | - |
| Ezetimibe | ACTIVE_COMPARATOR | - |
| Placebo QD | PLACEBO_COMPARATOR | - |
| Lapaquistat Acetate 50 mg QD + Atorvastatin | EXPERIMENTAL | - |
| Lapaquistat Acetate 100 mg QD + Atorvastatin | EXPERIMENTAL | - |
| Atorvastatin | ACTIVE_COMPARATOR | - |
| Lapaquistat Acetate 100 mg QD + Atorvastatin 10 mg QD | EXPERIMENTAL | - |
| Atorvastatin 10 mg QD | ACTIVE_COMPARATOR | - |
| Lapaquistat Acetate 100 mg QD + Fenofibrate 145 mg QD | EXPERIMENTAL | - |
| Fenofibrate 145 mg QD | ACTIVE_COMPARATOR | - |
| Lapaquistat Acetate 100 mg QD + Atorvastatin QD | EXPERIMENTAL | - |
| Atorvastatin QD | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Lapaquistat acetate and simvastatin | DRUG | Lapaquistat acetate 50 mg, tablets, orally, once daily and stable dose of simvastatin for up to 12 weeks. |
| Simvastatin | DRUG | Lapaquistat acetate placebo-matching tablets, orally, once daily and stable dose of simvastatin for up to 12 weeks. |
| Lapaquistat acetate | DRUG | Participants from 01-04-TL-475-008 Monotherapy Study: Lapaquistat acetate 100 mg, tablets, orally, once daily for up to 48 weeks. |
| Lapaquistat acetate and additional lipid-lowering therapy | DRUG | Participants from 01-04-TL-475-009 Atorvastatin Add-on Study: Lapaquistat acetate 100 mg, tablets, orally, once daily and current Atorvastatin therapy for up to 4 weeks. Then, Lapaquistat 100 mg, tablets, orally, once daily and dose adjustment of Atorvastatin OR additional companion lipid-lowering therapy as needed for target LDL-C for up to 42 weeks. |
| Lapaquistat acetate and rosuvastatin | DRUG | Lapaquistat acetate 50 mg, tablets, orally, once daily and stable Rosuvastatin therapy (10 or 20 mg) for up to 24 weeks. |
| Rosuvastatin | DRUG | Lapaquistat acetate placebo-matching tablets, orally, once daily and stable Rosuvastatin therapy (10 or 20 mg) for up to 24 weeks. |
| Lapaquistat acetate and lipid-lowering therapy | DRUG | Lapaquistat acetate 50 mg, tablets, orally, once daily and stable lipid-lowering therapy for up to 24 weeks. |
| Lipid-lowering therapy | DRUG | Lapaquistat acetate placebo-matching tablets, tablets, orally, once daily and stable lipid-lowering therapy for up to 24 weeks. |
| Lapaquistat acetate and ezetimibe | DRUG | Lapaquistat acetate 100 mg, tablets, orally, once daily and stable ezetimibe therapy for up to 24 weeks. |
| Ezetimibe | DRUG | Lapaquistat acetate placebo-matching tablets, orally, once daily and stable ezetimibe therapy for up to 24 weeks. |
| Placebo | DRUG | Lapaquistat acetate placebo-matching tablets, orally, once daily for up to 12 weeks |
| Lapaquistat acetate and atorvastatin | DRUG | Lapaquistat acetate 50 mg, tablets, orally, once daily and Atorvastatin 10 mg to 40 mg stable dose for up to 24 weeks. |
| Atorvastatin | DRUG | Lapaquistat acetate placebo-matching tablets, orally, once daily and Atorvastatin 10 mg to 40 mg stable dose for up to 24 weeks. |
| Lapaquistat acetate and fenofibrate | DRUG | Lapaquistat acetate 100 mg, tablets, orally, once daily and fenofibrate 145 mg, tablets, orally, once daily for up to 12 weeks. |
| Fenofibrate | DRUG | Lapaquistat acetate placebo-matching tablets, orally, once daily and fenofibrate 145 mg, tablets, orally, once daily for up to 12 weeks. |
Inclusion Criteria: * Woman of childbearing potential can not to be pregnant, lactating, not planning on becoming pregnant, and agree to use acceptable forms of contraception throughout the course of the study. * Prior to Randomization, has a low-density lipoprotein cholesterol level mean greater t...
Top 7 of 10 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Enlicitide |
| Eli Lilly and Company | LLY | 2 | PHASE3 | Lepodisiran, Muvalaplin |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE3 | Pelacarsen |
| NewAmsterdam Pharma Company N.V. | NAMS | 3 | PHASE3 | Obicetrapib |
| AstraZeneca PLC | AZN | 2 | PHASE2 | Rosuvastatin, AZD0780, AZD4954 |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE1 | ARO-DIMERPA |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX310 |
Lapaquistat acetate is an investigational small molecule developed by Takeda Pharmaceutical Company Limited (TAK) for lipid disorders. It has been studied in Phase 3 clinical trials for dyslipidemia, hypercholesterolemia, hyperlipidemias, and type 2 diabetes. It is also known as lapaquistat and has been evaluated both alone and in combination with other lipid-lowering therapies.
Lapaquistat acetate has been studied for dyslipidemia, hypercholesterolemia, hyperlipidemias, and type 2 diabetes. Clinical trials evaluated it both as monotherapy and coadministered with other lipid-lowering agents such as atorvastatin, fenofibrate, simvastatin, and rosuvastatin. It remains an investigational therapy and is not approved for any indication.
Lapaquistat acetate targets FDFT1, also known as squalene synthase. It acts as an inhibitor of this enzyme, which sits in the cholesterol biosynthesis pathway. By inhibiting FDFT1, the drug is designed to reduce cholesterol synthesis, a mechanism distinct from statins, which target HMG-CoA reductase.
Lapaquistat acetate is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda sponsored the clinical development program, including the Phase 3 safety and efficacy trials conducted in patients with hypercholesterolemia and primary dyslipidemia.
Lapaquistat acetate reached Phase 3 clinical development. Seven trials have been completed, including Phase 3 studies in hypercholesterolemia and primary dyslipidemia, and no trials are currently active. The program enrolled a total of 4,649 participants across randomized, double-blind, active-controlled studies.
Completed trials include NCT00487994, a Phase 3 study of lapaquistat acetate alone and with atorvastatin in primary dyslipidemia that enrolled 2,130 participants, and NCT00868127, a Phase 3 safety study in hypercholesterolemia with 574 participants. Phase 2 trials include NCT00864643 with atorvastatin and NCT00813527 with fenofibrate.
Yes. Lapaquistat acetate is the acetate salt form of lapaquistat, and the two names refer to the same investigational compound. It has also been studied in combination regimens, so searches for lapaquistat and fenofibrate, lapaquistat and atorvastatin, lapaquistat and simvastatin, and lapaquistat and rosuvastatin all refer to those combination studies.