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MGL-3196
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.
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.
At a glance
| Generic name | MGL-3196 |
|---|---|
| Also known as | VIA-3196, Resmetirom |
| Sponsor | Madrigal Pharmaceuticals, Inc. |
| Drug class | Thyroid hormone receptor beta (THR-β) selective agonist |
| Target | THR-β (thyroid hormone receptor beta) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
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.
Approved indications
- Non-alcoholic fatty liver disease (NAFLD) with elevated transaminases
- Dyslipidemia and cholesterol management in patients with cardiovascular risk
Common side effects
- Increased heart rate
- Thyroid hormone elevation
- Gastrointestinal effects
Key clinical trials
- Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH (PHASE2)
- Study of MGL-3196 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) (PHASE2)
- Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH) (PHASE2)
- 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 (PHASE1)
- 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) (PHASE3)
- A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES) (PHASE3)
- A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis (PHASE3)
- 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 (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- MGL-3196 CI brief — competitive landscape report
- MGL-3196 updates RSS · CI watch RSS
- Madrigal Pharmaceuticals, Inc. portfolio CI