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Small Molecule

Mitapivat for Liver Impairment

Phase 1
Waitlist Available
Research Sponsored by Agios Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 17
Awards & highlights

Study Summary

This trial compares the effects of a medication in people with impaired livers to people with healthy livers.

Eligible Conditions
  • Liver Impairment

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 17
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 17 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Plasma Concentration-Time Curve From Time 0 (Predose) to Extrapolated to Infinity Time (AUC∞) of Mitapivat
Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) of Mitapivat
Maximum Plasma Concentration (Cmax) of Mitapivat
Secondary outcome measures
Apparent Total Clearance (CL/F) of Mitapivat
Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Mitapivat
Fraction Unbound (fu) for Mitapivat in Plasma
+7 more

Side effects data

From 2020 Phase 3 trial • 80 Patients • NCT03548220
50%
Gastroenteritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Experimental: AG-348, 5 mg
Experimental: AG-348, 20 mg
Experimental: AG-348, 50 mg
Placebo Comparator: Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: MitapivatExperimental Treatment1 Intervention
Mitapivat tablet as a single oral dose, under fasted conditions on Day 1 to compare participants with normal hepatic function to participants with moderate hepatic function (Child-Pugh [C-P] Score B, score of 7 to 9).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mitapivat
2023
Completed Phase 1
~20

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Agios Pharmaceuticals, Inc.Lead Sponsor
52 Previous Clinical Trials
4,186 Total Patients Enrolled
Medical AffairsStudy ChairAgios Pharmaceuticals, Inc.
39 Previous Clinical Trials
8,540 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How efficacious is Mitapivat in providing a safe and secure environment for patients?

"Current evidence surrounding Mitapivat's safety and efficacy is limited, resulting in a score of 1."

Answered by AI

Who qualifies to participate in this clinical trial?

"To participate in this experiment, individuals must range from 18 to 65 years old and have a moderate degree of liver damage. The research team is seeking 20 volunteers for the trial."

Answered by AI

Are there any vacancies available to participate in this research?

"Affirmative, clinicaltrials.gov data suggests this medical study is recruiting participants. This trial was posted on December 16th 2022 and most recently amended on January 11th 2023. It requires the recruitment of 20 patients from two sites."

Answered by AI

Does this research include individuals aged 50 and above as participants?

"The eligibility requirements for this clinical trial necessitate that participants are between 18 and 65 years old. There is an additional 24 trials available to those under the age of 18, while 216 more can be found by those over 65."

Answered by AI

What is the upper limit on participants in this clinical experiment?

"Yes, the information available on clinicaltrials.gov confirms that this trial is actively recruiting patients. It was first advertised in December 16th 2022 and updated most recently in January 11st 2023. The study aims to enrol a total of 20 participants across two distinct medical sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Pharmacokinetic Study of Mitapivat in Participants With Moderate Hepatic Impairment Compared to Matched Healthy Control Participants With Normal Hepatic Function
2023. "A Pharmacokinetic Study of Mitapivat in Participants With Moderate Hepatic Impairment Compared to Matched Healthy Control Participants With Normal Hepatic Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05610657.
~9 spots leftby Apr 2025
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