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NCT06397872 · ClinicalTrials.gov registry record · Phase 1
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 study, sponsored by Madrigal Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT06397872: Completed Phase 1 study, sponsored by Madrigal Pharmaceuticals.
NCT06397872 is a Phase 1 study that has completed, run by Madrigal Pharmaceuticals. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06397872, a Phase 1 study, has completed, sponsored by Madrigal Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study 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.
Primary Outcome
Cmax after administration
Interventions
- DRUG 100 mg Resmetirom Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2024-03-06 |
| Est. Completion | 2024-12-31 |
| Phase | Phase 1 |
What the finished NCT06397872 record still lists
NCT06397872 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which 100 mg Resmetirom Tablet is the first listed.
NCT06397872 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06397872 about?
NCT06397872 is a clinical study titled "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". 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 n...
What is the current status of trial NCT06397872?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2024-03-06. Estimated completion is 2024-12-31.
What interventions are being tested in trial NCT06397872?
The interventions under investigation include: 100 mg Resmetirom Tablet (DRUG).
Who is sponsoring clinical trial NCT06397872?
This trial is sponsored by Madrigal Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06397872's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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