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This is an evaluation of Aldafermin (NGM282) in an open-label, single-dose and parallel group study in participants with Impaired Hepatic Function
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Child-Pugh A (Mild Hepatic Impairment) & Healthy Matched | Experimental | Administered by subcutaneous injection |
|
| Child-Pugh B (Moderate Hepatic Impairment) & Healthy Matched | Experimental | Administered by subcutaneous injection |
|
| Child-Pugh C (Severe Hepatic Impairment) & Healthy Matched | Experimental | Administered by subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aldafermin | Biological | Biological: Aldafermin (NGM282) Subcutaneous Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Type and frequency of adverse events (Day 1 through Day 11) | Frequency, severity, timing, and/or duration of treatment-emergent adverse events (TEAE) and serious adverse events (SAEs) | 11 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics (PD) of biomarker 7-alpha-hydroxy-4-cholesten-3-one (C4) | Absolute change from baseline | 6 and 24 hours post dose |
| Pharmacodynamics (PD) of biomarker 7-alpha-hydroxy-4-cholesten-3-one (C4) |
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:
Negative test for drugs of abuse at Screening unless they are currently prescribed
Negative human immunodeficiency virus (HIV) antibody screen at Screening
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| NGM Study Director | NGM Biopharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NGM Clinical Study Site 110 | Miami | Florida | 33014 | United States | ||
| NGM Clinical Study Site 111 |
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| ID | Term |
|---|---|
| C000710649 | aldafermin |
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|
Percent change from baseline
| 6 and 24 hours post dose |
| Orlando |
| Florida |
| 32809 |
| United States |
| NGM Clinical Study Site 113 | San Antonio | Texas | 78215 | United States |