Drug updated on 7/25/2024
Dosage Form | Tablet (oral; 60 mg, 80 mg, 100 mg) |
Drug Class | Thyroid hormone receptor-beta agonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).
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Summary
- Resmetirom (Rezdiffra) is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).
- The information was derived from two randomized controlled trials.
- In a Phase 3 trial, resmetirom showed superior outcomes compared to placebo in NASH resolution and fibrosis improvement, achieving significant reductions in LDL-C levels as well.
- Safety data revealed that while diarrhea and nausea were more common among those taking resmetirom, serious adverse events occurred at similar rates across all groups (~11-13%).
- Another Phase 3 trial demonstrated high but comparable incidence rates of treatment-emergent adverse events between resmetirom and placebo groups; however, significant improvements were noted in secondary endpoints like hepatic fat reduction.
- Population types included adults diagnosed or presumed to have NASH; specific subgroup details such as age ranges or comorbidities were not provided.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
REZDIFFRA (resmetirom) Prescribing Information | 2024 | Madrigal Pharmaceuticals Inc., West Conshohocken, PA |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis. | Data not availableSubjects F: null% M: null% | 2024 | New England Journal of Medicine |
Resmetirom for nonalcoholic fatty liver disease: a randomized, double-blind, placebo-controlled phase 3 trial. | 1,143Subjects F: 57% M: 43% | 2023 | Nature Medicine |
Sex Distribution:
![No Data](/img/Nodata_Icon.png)
Year:
2024
Source:New England Journal of Medicine
Document Title
Sex Distribution:
F:57%
M:43%
1143Subjects
Year:
2023
Source:Nature Medicine