Skip to main content
OpenTrials
Completed

NCT Number: NCT04823702

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

NGM Clinical Study Site 110, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Aldafermin

Biological

Biological: Aldafermin (NGM282) Subcutaneous Injection

Other names: NGM282

Primary outcomes

  1. Pharmacokinetics (PK) of a single dose aldafermin

    Time frame: 4 days

    Maximum observed plasma concentration (Cmax) of aldafermin (Day 1 through Day 4)

  2. Pharmacokinetics of a single dose of aldafermin

    Time frame: 4 days

    Area under the concentration-time curve from time zero extrapolated to infinity (AUC infinity) of aldafermin (Day 1 through Day 4)

Secondary outcomes

  1. Type and frequency of adverse events (Day 1 through Day 11)

    Time frame: 11 days

    Frequency, severity, timing, and/or duration of treatment-emergent adverse events (TEAE) and serious adverse events (SAEs)

Other outcomes

  1. Pharmacodynamics (PD) of biomarker 7-alpha-hydroxy-4-cholesten-3-one (C4)

    Time frame: 6 and 24 hours post dose

    Absolute change from baseline

  2. Pharmacodynamics (PD) of biomarker 7-alpha-hydroxy-4-cholesten-3-one (C4)

    Time frame: 6 and 24 hours post dose

    Percent change from baseline

Sponsors and collaborators

Lead sponsor

NGM Biopharmaceuticals, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2021
Registry last updated
Jan 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.