NCT06397872

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

A Phase 1, Multi-center, Open-label 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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Madrigal Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	100 mg Resmetirom Tablet	Once daily oral dose for 6 days

Timeline

• Start date: 2024-03-06
• Primary completion: 2024-09-16
• Completion: 2024-12-31
• First posted: 2024-05-03
• Last updated: 2025-10-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study