28 Participants Needed

Resmetirom for Kidney Failure

Recruiting at 2 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Madrigal Pharmaceuticals, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 1 JurisdictionThis treatment is already approved in other countries

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

EC

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

I understand the study details and agree to participate.
I weigh over 50 kg, my BMI is between 18 and 45, and I have severe kidney issues but am otherwise healthy.
I am healthy, with normal kidney function, and my BMI and age match a patient with severe renal impairment.

Exclusion Criteria

I have severe kidney issues with specific thyroid levels, or a history of major health problems.
All Subjects: Gilbert's syndrome, pre-existing condition interfering with normal gastrointestinal anatomy or motility, or hepatic function, TSH < 0.3 or > 7 mIU/L, evidence or history of clinically significant diseases, failed renal transplant, end stage renal disease, abnormal blood pressure or heart rate
I am healthy with no liver, thyroid, significant diseases, or abnormal heart rates.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 100 mg resmetirom orally once daily for 6 days

6 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 days

Treatment Details

Interventions

  • Resmetirom
Trial Overview The study tests how a drug called Resmetirom behaves in the body when taken orally at a dose of 100 mg daily for six days by people with severe renal impairment compared to healthy individuals.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Severe renal impairmentExperimental Treatment1 Intervention
Group II: Normal Healthy MatchExperimental Treatment1 Intervention
Matched to severe renal impairment

Resmetirom is already approved in United States for the following indications:

🇺🇸
Approved in United States as Rezdiffra for:
  • 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

Trials
16
Recruited
5,400+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security