Resmetirom for Kidney Failure
Trial Summary
What is the purpose of this trial?
The purpose of this study is to directly characterize the pharmacokinetic (PK) profiles of resmetirom and its major metabolite (MGL-3623) following oral administration of 100 mg resmetirom (QD x 6 days) in subjects with severe renal impairment (RI) compared to healthy matched control subjects with normal renal function.
Research Team
Edward Chiang
Principal Investigator
Madrigal Pharmaceuticals, Inc.
Eligibility Criteria
This trial is for adults with severe kidney failure and those who are healthy with normal kidney function. Participants will be matched based on factors like age, weight, and gender. People cannot join if they have other significant health issues or are taking medications that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 100 mg resmetirom orally once daily for 6 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Resmetirom
Resmetirom is already approved in United States for the following indications:
- Noncirrhotic nonalcoholic steatohepatitis with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Madrigal Pharmaceuticals, Inc.
Lead Sponsor