Study of Aldafermin (NGM282) in Participants With Impaired Hepatic Function

A Phase I, Open-label, Parallel-group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Aldafermin in Subjects With Impaired Hepatic Function

NCT04823702•NGM Biopharmaceuticals, Inc

View on ClinicalTrials.gov

Summary

This is an evaluation of Aldafermin (NGM282) in an open-label, single-dose and parallel group study in participants with Impaired Hepatic Function

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Males or females, 18 - 75 years of age, inclusive
•2. Able to comprehend and willing to sign an informed consent form (ICF)
•3. Willing and able to comply with all study requirements
•4. BMI 18 - 40 kg/m2, inclusive at Screening
•5. Stable medication regimen - no medication initiation or dose change within 7 days or 5 half-lives (whichever is longer) prior to dosing of the study medication.
•6. Non-pregnant, non-lactating females. Female subjects of childbearing potential and male subjects with a female sexual partner of childbearing potential must agree to consistent and adequate birth control. One of the following forms of contraception is required:
•1. Condom
•2. Hormone containing contraceptive
•3. Intrauterine device with a failure rate \< 1% per year
•4. Cervical cap or diaphragm with spermicidal agent
+5 more criteria

Exclusion Criteria

•1. Any acute disease or condition being treated by medical therapy (prescription or over the counter) known to possibly impact hepatic function
•2. History of or recent (\< 6 weeks) treatment for a chronic condition with a medication that is known to have hepatotoxic potential.
•3. Any significant physical injury or surgical procedure within 6 weeks of Screening
•4. Uncontrolled diabetes (hemoglobin A1c \[HbA1c\] \> 9.5%)
•5. Uncontrolled hypertension (systolic blood pressure \[SBP\] \> 180 mmHg on ≥ 3 medications of different classes for blood pressure control)
•6. Have received any investigational medication within 30 days or 5 half-lives, whichever is longer, prior to study dosing
•7. Subjects should not have donated blood within 60 days of study entry or plasma within 7 days of study entry. Subjects must also refrain from blood donation from clinic admission, throughout the study period, and continuing for at least 30 days following the last dose of study medication.
•8. Positive urine drug screen at Screening that is not otherwise explained by a permitted concomitant medication
•9. History of alcoholism in the 6 months prior to Screening
•10. Inadequate peripheral venous access

Locations (3)

NGM Clinical Study Site 110

Miami, Florida, United States

NGM Clinical Study Site 111

Orlando, Florida, United States

NGM Clinical Study Site 113

San Antonio, Texas, United States

Key Dates

Start Date

April 1, 2021

Primary Completion Date

November 19, 2021

Completion Date

November 19, 2021

Last Updated

January 19, 2022

Enrollment

ACTUAL participants

Conditions

Impaired Hepatic Function

Interventions

Aldafermin

BIOLOGICAL

Pharmacokinetics Study in Patients With Impaired Hepatic Function

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COMPLETEDPHASE1

Evaluating Patients With Impaired Hepatic Function

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TERMINATEDPHASE1

A Pharmacokinetic Study of Padsevonil in Study Participants With Either Normal or Moderately Impaired Hepatic Function

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 19, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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