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

NGM Biopharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Impaired Hepatic Function

Treatments: Biological: Aldafermin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04823702

282-HI-104

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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. Tubal sterilization
   6. Vasectomy in male partner
   7. Sexual abstinence

7. Negative test for drugs of abuse at Screening unless they are currently prescribed

8. Negative human immunodeficiency virus (HIV) antibody screen at Screening

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

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

Experimental group

Description:

Administered by subcutaneous injection

Treatment:

Biological: Aldafermin

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

Experimental group

Description:

Administered by subcutaneous injection

Treatment:

Biological: Aldafermin

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

Experimental group

Description:

Administered by subcutaneous injection

Treatment:

Biological: Aldafermin