{"id":"mgl-3196","safety":{"commonSideEffects":[{"rate":null,"effect":"Increased heart rate"},{"rate":null,"effect":"Thyroid hormone elevation"},{"rate":null,"effect":"Gastrointestinal effects"}]},"_chembl":{"chemblId":"CHEMBL3261331","moleculeType":"Small molecule","molecularWeight":"435.23"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"MGL-3196 selectively binds and activates the beta isoform of the thyroid hormone receptor, which is predominantly expressed in the liver. This activation increases the catabolism of LDL cholesterol and reduces triglyceride production. By targeting THR-β specifically rather than the alpha isoform (which mediates systemic thyroid effects), the drug aims to achieve lipid-lowering benefits with reduced cardiac and metabolic side effects associated with non-selective thyroid hormone agonism.","oneSentence":"MGL-3196 is a thyroid hormone receptor beta (THR-β) selective agonist that activates THR-β to reduce cholesterol and triglycerides while minimizing systemic thyroid hormone effects.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:21:12.374Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-alcoholic fatty liver disease (NAFLD) with elevated transaminases"},{"name":"Dyslipidemia and cholesterol management in patients with cardiovascular risk"}]},"trialDetails":[{"nctId":"NCT07335601","phase":"PHASE2","title":"Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH","status":"ACTIVE_NOT_RECRUITING","sponsor":"Madrigal Pharmaceuticals, Inc.","startDate":"2025-12-29","conditions":"MASH - Metabolic Dysfunction-Associated Steatohepatitis","enrollment":120},{"nctId":"NCT03038022","phase":"PHASE2","title":"Study of MGL-3196 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)","status":"COMPLETED","sponsor":"Madrigal Pharmaceuticals, Inc.","startDate":"2017-02-23","conditions":"Heterozygous Familial Hypercholesterolemia","enrollment":116},{"nctId":"NCT02912260","phase":"PHASE2","title":"Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH)","status":"COMPLETED","sponsor":"Madrigal Pharmaceuticals, Inc.","startDate":"2016-10-18","conditions":"Non-alcoholic Steatohepatitis","enrollment":125},{"nctId":"NCT06397872","phase":"PHASE1","title":"A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses (6 Days) of 100 mg Resmetirom in Subjects With Severe Renal Impairment and in Matched Healthy Control Subjects With Normal Renal Function","status":"COMPLETED","sponsor":"Madrigal Pharmaceuticals, Inc.","startDate":"2024-03-06","conditions":"Renal Impairment","enrollment":28},{"nctId":"NCT04951219","phase":"PHASE3","title":"A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Madrigal Pharmaceuticals, Inc.","startDate":"2021-07-09","conditions":"Non-Alcoholic Fatty Liver Disease","enrollment":1000},{"nctId":"NCT05500222","phase":"PHASE3","title":"A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Madrigal Pharmaceuticals, Inc.","startDate":"2022-08-26","conditions":"NASH, Cirrhosis, Liver","enrollment":700},{"nctId":"NCT03900429","phase":"PHASE3","title":"A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Madrigal Pharmaceuticals, Inc.","startDate":"2019-03-28","conditions":"NASH - Nonalcoholic Steatohepatitis","enrollment":1759},{"nctId":"NCT04643795","phase":"PHASE1","title":"Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects","status":"COMPLETED","sponsor":"Madrigal Pharmaceuticals, Inc.","startDate":"2018-10-25","conditions":"Hepatic Impairment, NASH - Nonalcoholic Steatohepatitis, Cirrhosis, Liver","enrollment":87},{"nctId":"NCT04197479","phase":"PHASE3","title":"A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Non Alcoholic Fatty Liver Disease Patients","status":"COMPLETED","sponsor":"Madrigal Pharmaceuticals, Inc.","startDate":"2019-12-16","conditions":"Non-Alcoholic Fatty Liver Disease","enrollment":1343},{"nctId":"NCT02542969","phase":"PHASE1","title":"Drug Interaction Study of MGL-3196 With Rosuvastatin and Simvastatin","status":"COMPLETED","sponsor":"Madrigal Pharmaceuticals, Inc.","startDate":"2015-09","conditions":"Healthy","enrollment":25},{"nctId":"NCT04671069","phase":"PHASE1","title":"Drug Interaction Study of MGL-3196 With Clopidogrel","status":"COMPLETED","sponsor":"Madrigal Pharmaceuticals, Inc.","startDate":"2019-07-26","conditions":"Healthy","enrollment":20},{"nctId":"NCT04671056","phase":"PHASE1","title":"Drug Interaction Study of MGL-3196 With Pioglitazone","status":"COMPLETED","sponsor":"Madrigal Pharmaceuticals, Inc.","startDate":"2018-11-09","conditions":"Healthy","enrollment":16},{"nctId":"NCT03413124","phase":"PHASE1","title":"Bioavailability Study of MGL-3196 Tablets Compared to Capsules","status":"COMPLETED","sponsor":"Madrigal Pharmaceuticals, Inc.","startDate":"2018-02-05","conditions":"Healthy","enrollment":16},{"nctId":"NCT03220165","phase":"PHASE1","title":"Radiolabeled Study to Determine the Mass Balance of [14C] MGL-3196","status":"COMPLETED","sponsor":"Madrigal Pharmaceuticals, Inc.","startDate":"2017-08-06","conditions":"Healthy","enrollment":8},{"nctId":"NCT02749578","phase":"PHASE1","title":"Drug Interaction Study of MGL-3196 With Atorvastatin","status":"COMPLETED","sponsor":"Madrigal Pharmaceuticals, Inc.","startDate":"2016-04","conditions":"Healthy","enrollment":14}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":31,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["VIA-3196","Resmetirom"],"phase":"phase_3","status":"active","brandName":"MGL-3196","genericName":"MGL-3196","companyName":"Madrigal Pharmaceuticals, Inc.","companyId":"madrigal-pharmaceuticals-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"MGL-3196 is a thyroid hormone receptor beta (THR-β) selective agonist that activates THR-β to reduce cholesterol and triglycerides while minimizing systemic thyroid hormone effects. Used for Non-alcoholic fatty liver disease (NAFLD) with elevated transaminases, Dyslipidemia and cholesterol management in patients with cardiovascular risk.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":5,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}