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

NCT04823702 | Completed Phase 1 FDA Drug

• 1 other identifier: 282-HI-104
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Impaired Hepatic Function

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK) of a single dose aldafermin

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

  4 days

• Pharmacokinetics of a single dose of aldafermin

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

  4 days

Secondary Outcomes (1)

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

  11 days

Other Outcomes (2)

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

  6 and 24 hours post dose

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

  6 and 24 hours post dose

Study Arms (3)

Child-Pugh A (Mild Hepatic Impairment) & Healthy Matched

EXPERIMENTAL

Administered by subcutaneous injection

Biological: Aldafermin

Child-Pugh B (Moderate Hepatic Impairment) & Healthy Matched

EXPERIMENTAL

Administered by subcutaneous injection

Biological: Aldafermin

Child-Pugh C (Severe Hepatic Impairment) & Healthy Matched

EXPERIMENTAL

Administered by subcutaneous injection

Biological: Aldafermin

Interventions

Aldafermin BIOLOGICAL

Biological: Aldafermin (NGM282) Subcutaneous Injection

Also known as: NGM282

Child-Pugh A (Mild Hepatic Impairment) & Healthy Matched; Child-Pugh B (Moderate Hepatic Impairment) & Healthy Matched; Child-Pugh C (Severe Hepatic Impairment) & Healthy Matched

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• NGM Biopharmaceuticals, Inc: lead

Study Sites (3)

NGM Clinical Study Site 110

Miami, Florida, 33014, United States

Location

NGM Clinical Study Site 111

Orlando, Florida, 32809, United States

Location

NGM Clinical Study Site 113

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Interventions

aldafermin

Study Officials

• NGM Study Director

  NGM Biopharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 1, 2021
• Study Start: April 1, 2021
• Primary Completion: November 19, 2021
• Study Completion: November 19, 2021
• Last Updated: January 19, 2022

Record last verified: 2021-12

Locations

US (3)