{"id":"aleglitazar","rwe":[{"n":null,"pmid":"29903845","year":"2018","title":"Adiponectin, Free Fatty Acids, and Cardiovascular Outcomes in Patients With Type 2 Diabetes and Acute Coronary Syndrome.","finding":"","journal":"Diabetes care","studyType":"Observational"}],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT00461058","NCT01893242","NCT01715818","NCT01042769","NCT01398267","NCT01691846","NCT00461006","NCT01871415","NCT01691989","NCT01701739","NCT01691755","NCT01043029","NCT01679639","NCT01197911","NCT01188304","NCT01188317","NCT01615354","NCT01729403","NCT01680978","NCT00388518","NCT01711775","NCT01871428"],"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[{"date":"2007","type":"neutral","milestone":"Phase 2 Initiated","description":"A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and New York  — Diabetes Mellitus Type 2"},{"date":"2010","type":"neutral","milestone":"Phase 1 Initiated","description":"A Study of Aleglitazar in Combination With Aspirin in Healthy Volunteers — Healthy Volunteer"},{"date":"2013","type":"neutral","milestone":"Phase 3 Initiated","description":"A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who A — Diabetes Mellitus Type 2"}],"aiSummary":"Aleglitazar is an approved drug studied for its potential to reduce cardiovascular risk. Clinical trials have evaluated its effects on cardiac energetics and function, as well as its use in treating type 2 diabetes. It has been investigated in various phases of clinical development, including Phase 3 trials.","brandName":"ALEGLITAZAR","companyId":"unknown","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"Small molecule","drugClass":"","explanation":"Aleglitazar's mechanism involves impacting cardiac energetics and function. Studies are exploring how it affects the heart's ability to produce and use energy. This research aims to understand if Aleglitazar can improve heart health in individuals with certain medical conditions.","oneSentence":"Aleglitazar is being studied to see if it can lower cardiovascular risk and improve heart function in people with diabetes.","technicalDetail":"Aleglitazar has been the subject of Phase 3 trials with 1999 participants focused on reducing cardiovascular risk in stable cardio patients. Phase 2 trials, involving 18 participants, evaluated its effect on cardiac energetics and function in patients with Type 2 diabetes. A Phase 3 trial with 13 participants studied Aleglitazar as a monotherapy for drug-naïve patients with Type 2 Diabetes Mellitus."},"commercial":null,"references":[],"biosimilars":[],"companyName":"","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"}],"genericName":"ALEGLITAZAR","indications":{"approved":[],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT00461058","phase":"Phase 2","title":"A Randomized, Double Blind Study to Compare the Safety and Tolerability of Aleglitazar and Actos in Patients With Type 2 Diabetes and NYHA Class II Heart Failure.","status":"COMPLETED","sponsor":"Hoffmann-La Roche","isPivotal":false,"enrollment":14,"indication":"Diabetes Mellitus Type 2","completionDate":"2007-12"},{"nctId":"NCT01893242","phase":"Phase 3","title":"A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE POTENTIAL OF ALEGLITAZAR TO REDUCE THE RISK OF END STAGE RENAL DISEASE AND CARDIOVASCULAR MORTALITY IN PATIENTS WITH TYPE","status":"WITHDRAWN","sponsor":"Hoffmann-La Roche","isPivotal":true,"enrollment":0,"indication":"Diabetes Mellitus Type 2, Kidney Disease, Chronic","completionDate":"2019-01"},{"nctId":"NCT01715818","phase":"Phase 3","title":"A PHASE 3B STUDY TO EVALUATE THE POTENTIAL OF ALEGLITAZAR TO REDUCE CARDIOVASCULAR RISK IN PATIENTS WITH STABLE CARDIOVASCULAR DISEASE AND GLUCOSE ABNORMALITIES","status":"COMPLETED","sponsor":"Hoffmann-La Roche","isPivotal":true,"enrollment":1999,"indication":"Cardiovascular Disease, Diabetes Mellitus Type 2","completionDate":"2013-11"},{"nctId":"NCT01042769","phase":"Phase 3","title":"A Safety and Efficacy Study to Evaluate the Potential of Aleglitazar to Reduce Cardiovascular Risk in Coronary Heart Disease (CHD) Patients With a Recent Acute Coronary Syndrome (ACS) Event and Type 2","status":"COMPLETED","sponsor":"Hoffmann-La Roche","isPivotal":true,"enrollment":7226,"indication":"Diabetes Mellitus Type 2","completionDate":"2013-11"},{"nctId":"NCT01398267","phase":"Phase 1","title":"A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Effects of Aleglitazar 150 µg in Type 2 Diabetic Patients Treated With Lisinopril 20 mg on Renal Function, the R","status":"COMPLETED","sponsor":"Hoffmann-La Roche","isPivotal":false,"enrollment":55,"indication":"Diabetes Mellitus Type 2","completionDate":"2012-10"},{"nctId":"NCT01691846","phase":"Phase 3","title":"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Assess the Efficacy, Safety and Tolerability of Aleglitazar Plus Metformin Combination Therapy Compared With Placebo Plu","status":"COMPLETED","sponsor":"Hoffmann-La Roche","isPivotal":true,"enrollment":200,"indication":"Diabetes Mellitus Type 2","completionDate":"2013-09"},{"nctId":"NCT00461006","phase":"Phase 2","title":"A Randomized, Double Blind Study to Compare the Effects of Aleglitazar and Actos on Glomerular Filtration Rate and Other Parameters of Renal Function in Patients With Type 2 Diabetes.","status":"COMPLETED","sponsor":"Hoffmann-La Roche","isPivotal":false,"enrollment":176,"indication":"Diabetes Mellitus Type 2","completionDate":"2008-09"},{"nctId":"NCT01871415","phase":"Phase 3","title":"A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF ALEGLITAZAR PLUS METFORMIN COMBINATION THERAPY COMPARED WITH PLACEBO PLU","status":"COMPLETED","sponsor":"Hoffmann-La Roche","isPivotal":true,"enrollment":7,"indication":"Diabetes Mellitus Type 2","completionDate":"2013-08"},{"nctId":"NCT01691989","phase":"Phase 3","title":"A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PHASE III STUDY TO ASSESS THE EFFICACY,SAFETY AND TOLERABILITY OF ALEGLITAZAR ADDED TO A SU OR ADDED TO A SU IN COMBINATION WITH MET IN PATI","status":"COMPLETED","sponsor":"Hoffmann-La Roche","isPivotal":true,"enrollment":197,"indication":"Diabetes Mellitus Type 2","completionDate":"2013-09"},{"nctId":"NCT01701739","phase":"Phase 1","title":"An Open-label, Two-period Fixed-sequence Study to Investigate the Effect of Multiple Doses of Aleglitazar on a Single Dose of Digoxin in Healthy Subjects","status":"COMPLETED","sponsor":"Hoffmann-La Roche","isPivotal":false,"enrollment":28,"indication":"Healthy Volunteer","completionDate":"2013-01"},{"nctId":"NCT01691755","phase":"Phase 3","title":"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Assess the Efficacy, Safety and Tolerability of Aleglitazar Monotherapy Compared With Placebo in Patients With Type 2 Di","status":"COMPLETED","sponsor":"Hoffmann-La Roche","isPivotal":true,"enrollment":196,"indication":"Diabetes Mellitus Type 2","completionDate":"2013-09"},{"nctId":"NCT01043029","phase":"Phase 2","title":"Effects of 150 mcg Aleglitazar on Renal Function in Patients With Type 2 Diabetes and Moderate Renal Impairment, as Compared to Actos®","status":"COMPLETED","sponsor":"Hoffmann-La Roche","isPivotal":false,"enrollment":302,"indication":"Diabetes Mellitus Type 2","completionDate":"2012-07"},{"nctId":"NCT01679639","phase":"Phase 1","title":"An Open-label, Fixed-sequence, Three-period, Single Group Study to Investigate the Effects of Rifampicin as an OATP1B1 Inhibitor and a CYP2C8 Inducer on the Pharmacokinetics of Aleglitazar in Healthy ","status":"COMPLETED","sponsor":"Hoffmann-La Roche","isPivotal":false,"enrollment":24,"indication":"Healthy Volunteer","completionDate":"2012-12"},{"nctId":"NCT01197911","phase":"Phase 1","title":"The Effect of Hepatic Impairment on the Pharmacokinetics of Aleglitazar: A Multiple-centre, Open-label Study Following a Single Oral Dose of Aleglitazar to Subjects With Mild or Moderate Hepatic Impai","status":"COMPLETED","sponsor":"Hoffmann-La Roche","isPivotal":false,"enrollment":38,"indication":"Healthy Volunteer","completionDate":"2011-08"},{"nctId":"NCT01188304","phase":"Phase 1","title":"A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Effect of 150 µg Aleglitazar Once Daily in Healthy Subjects Treated With 325 mg Aspirin Once Daily on Renal Func","status":"COMPLETED","sponsor":"Hoffmann-La Roche","isPivotal":false,"enrollment":44,"indication":"Healthy Volunteer","completionDate":"2010-10"},{"nctId":"NCT01188317","phase":"Phase 1","title":"A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Effect of Ibuprofen on Top of Multiple Doses of 150 µg Aleglitazar Once Daily on Renal Function, Renin-angiotens","status":"COMPLETED","sponsor":"Hoffmann-La Roche","isPivotal":false,"enrollment":44,"indication":"Healthy Volunteer","completionDate":"2011-09"},{"nctId":"NCT01615354","phase":"Phase 1","title":"Single-Center, Randomized, Double-Blind, Placebo Controlled, Crossover Study to Assess the Effect of Aleglitazar on the Pharmacokinetics and Pharmacodynamics of Ethinyl Estradiol and Levonorgestrel as","status":"COMPLETED","sponsor":"Hoffmann-La Roche","isPivotal":false,"enrollment":18,"indication":"Healthy Volunteer","completionDate":"2013-01"},{"nctId":"NCT01729403","phase":"Phase 2","title":"A Single Centre, Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy of Aleglitazar on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus (T2D) Who Are Inade","status":"COMPLETED","sponsor":"Hoffmann-La Roche","isPivotal":false,"enrollment":57,"indication":"Diabetes Mellitus Type 2","completionDate":"2013-09"},{"nctId":"NCT01680978","phase":"Phase 2","title":"A SINGLE CENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, CROSSOVER, PHASE II STUDY TO ASSESS THE EFFECT OF ALEGLITAZAR ON CARDIAC ENERGETICS AND FUNCTION IN PATIENTS WITH UNCOMPLICATED TYPE 2 DI","status":"COMPLETED","sponsor":"Hoffmann-La Roche","isPivotal":false,"enrollment":18,"indication":"Diabetes Mellitus Type 2","completionDate":"2013-09"},{"nctId":"NCT00388518","phase":"Phase 2","title":"A Randomized, Double-blind Study to Investigate the Effect of Aleglitazar on Glycemic Control in Patients With Type 2 Diabetes Mellitus.","status":"COMPLETED","sponsor":"Hoffmann-La Roche","isPivotal":false,"enrollment":332,"indication":"Diabetes Mellitus Type 2","completionDate":"2008-03"},{"nctId":"NCT01711775","phase":"Phase 1","title":"A Single-center, Non-randomized, Open-label Study to Assess the Pharmacokinetics of Aleglitazar (RO0728804) After Administration of Single and Multiple Oral Doses of 150 µg Tablet in Healthy Chinese S","status":"COMPLETED","sponsor":"Hoffmann-La Roche","isPivotal":false,"enrollment":16,"indication":"Healthy Volunteer","completionDate":"2012-12"},{"nctId":"NCT01871428","phase":"Phase 3","title":"A Multicenter, Randomized, Doubleblind, Placebo-Controlled, Phase III Study to Assess the Efficacy, Safety and Tolerability of Aleglitazar Monotherapy Compared With Placebo in Patients With Type 2 Dia","status":"COMPLETED","sponsor":"Hoffmann-La Roche","isPivotal":true,"enrollment":13,"indication":"Diabetes Mellitus Type 2","completionDate":"2013-11"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Metabolic"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Small molecule","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}