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

Completed · Phase 1

Conditions studied: Impaired Hepatic Function

In brief

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

Key facts

Study ID

NCT04823702

Run by

NGM Biopharmaceuticals, Inc

People needed

36

Starts

2021-04-01

Expected to finish

2021-11-19

Last updated by the study team

2022-01-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males or females, 18 - 75 years of age, inclusive
• Able to comprehend and willing to sign an informed consent form (ICF)
• Willing and able to comply with all study requirements
• BMI 18 - 40 kg/m2, inclusive at Screening
• 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.
• 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:
• Condom
• Hormone containing contraceptive
• Intrauterine device with a failure rate < 1% per year
• Cervical cap or diaphragm with spermicidal agent
• Tubal sterilization
• Vasectomy in male partner
• Sexual abstinence
• Negative test for drugs of abuse at Screening unless they are currently prescribed
• Negative human immunodeficiency virus (HIV) antibody screen at Screening

You may not qualify if…

• Any acute disease or condition being treated by medical therapy (prescription or over the counter) known to possibly impact hepatic function
• History of or recent (< 6 weeks) treatment for a chronic condition with a medication that is known to have hepatotoxic potential.
• Any significant physical injury or surgical procedure within 6 weeks of Screening
• Uncontrolled diabetes (hemoglobin A1c [HbA1c] > 9.5%)
• Uncontrolled hypertension (systolic blood pressure [SBP] > 180 mmHg on ≥ 3 medications of different classes for blood pressure control)
• Have received any investigational medication within 30 days or 5 half-lives, whichever is longer, prior to study dosing
• 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.
• Positive urine drug screen at Screening that is not otherwise explained by a permitted concomitant medication
• History of alcoholism in the 6 months prior to Screening
• Inadequate peripheral venous access

Where it is running

• 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

Full record on ClinicalTrials.gov

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