{"id":"abt-335-and-atorvastatin-calcium","safety":{"commonSideEffects":[{"rate":null,"effect":"Myalgia or muscle pain"},{"rate":null,"effect":"Elevated liver enzymes"},{"rate":null,"effect":"Gastrointestinal upset"},{"rate":null,"effect":"Rhabdomyolysis (rare)"}]},"_chembl":{"chemblId":"CHEMBL393220","moleculeType":"Small molecule","molecularWeight":"1155.36"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"ABT-335 (fenofibrate derivative) activates peroxisome proliferator-activated receptor alpha (PPARα) to increase lipolysis and reduce hepatic triglyceride production. Atorvastatin calcium is a statin that competitively inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby lowering LDL cholesterol. Together, this combination addresses multiple lipid abnormalities in dyslipidemia.","oneSentence":"ABT-335 is a fibrate that reduces triglycerides and raises HDL cholesterol, combined with atorvastatin calcium which inhibits HMG-CoA reductase to lower LDL cholesterol.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:58:41.915Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Dyslipidemia with elevated triglycerides and LDL cholesterol"}]},"trialDetails":[{"nctId":"NCT00616772","phase":"PHASE3","title":"Safety and Efficacy Study Using ABT-335 (Investigational Drug) in Combination With Atorvastatin, to Study the Effects on Thickening of the Blood Vessel Wall in Patients With Abnormal Lipid (Fat) Levels in the Blood","status":"COMPLETED","sponsor":"AbbVie (prior sponsor, Abbott)","startDate":"2008-02","conditions":"Coronary Artery Disease, Coronary Heart Disease, Dyslipidemia","enrollment":682},{"nctId":"NCT00728910","phase":"PHASE2","title":"Combined Effects of Non-statin Treatments on Apolipoprotein A-I Up-Regulation (CENTAUR): A Feasibility Study","status":"COMPLETED","sponsor":"University of Pennsylvania","startDate":"2008-06","conditions":"Dyslipidemia","enrollment":25},{"nctId":"NCT00491530","phase":"PHASE3","title":"A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia","status":"COMPLETED","sponsor":"Abbott","startDate":"2007-06","conditions":"Mixed Dyslipidemia","enrollment":310},{"nctId":"NCT00639158","phase":"PHASE3","title":"Safety and Efficacy Study Comparing ABT-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) Levels in the Blood","status":"COMPLETED","sponsor":"Abbott","startDate":"2008-02","conditions":"Dyslipidemias, Coronary Heart Disease, Combined (Atherogenic) Dyslipidemia","enrollment":543},{"nctId":"NCT00681525","phase":"PHASE1","title":"A Multiple-Dose Pharmacokinetic Interaction Study Between ABT-335, Atorvastatin and Ezetimibe","status":"COMPLETED","sponsor":"Abbott","startDate":"2008-04","conditions":"Pharmacokinetics","enrollment":18},{"nctId":"NCT00300430","phase":"PHASE3","title":"Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.","status":"COMPLETED","sponsor":"Abbott","startDate":"2006-09","conditions":"Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia","enrollment":1911},{"nctId":"NCT00300469","phase":"PHASE3","title":"Evaluate Safety and Efficacy of ABT-335 in Combination With Atorvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood","status":"COMPLETED","sponsor":"Abbott","startDate":"2006-03","conditions":"Mixed Dyslipidemia, Coronary Heart Disease, Dyslipidemia","enrollment":613}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["ABT-335","TRILIPIX"],"phase":"phase_3","status":"active","brandName":"ABT-335 and atorvastatin calcium","genericName":"ABT-335 and atorvastatin calcium","companyName":"Abbott","companyId":"abbott","modality":"Small molecule","firstApprovalDate":"","aiSummary":"ABT-335 is a fibrate that reduces triglycerides and raises HDL cholesterol, combined with atorvastatin calcium which inhibits HMG-CoA reductase to lower LDL cholesterol. Used for Dyslipidemia with elevated triglycerides and LDL cholesterol.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}