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

Study Overview
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Brief Summary
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This is a single-center evaluation of Aldafermin (NGM282) in an open-label, single-dose and parallel group study in participants with Impaired Renal Function.

Official Title
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A Phase 1, Single-center, Open Label, Parallel Group Study to Evaluate the Pharmacokinetics, Safety & Tolerability of a Single Dose of Aldafermin (NGM282) in Subjects With Impaired Renal Function

Conditions
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Impaired Renal Function

Intervention / Treatment
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* Biological: Aldafermin (NGM282)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current diagnosis of stable chronic kidney disease and eGFR, as assessed by the Modification of Diet in Renal Disease (MDRD) estimate: Mild renal impairment: eGFR 60-89 mL/min/1.73m² Moderate renal impairment: eGFR 30-59 mL/min/1.73m² Severe renal impairment: eGFR < 30 mL/min/1.73m² Healthy control subjects with normal renal function will be matched (age ± 10 years; sex, race, BMI ± 15%) to their respective subject in the impaired renal function groups and have eGFR ≥90 mL/min/1.73m . Healthy control subjects should have no systemic chronic disease. Males and Females age 18-75 Body mass index (BMI) 25-40 kg/m² Exclusion Criteria: Renal allograft recipients History of renal cell carcinoma or any history of metastatic disease involving the kidney End Stage Renal disease, requiring or not requiring dialysis Subject requiring or anticipated requirement of dialysis within 3 months of study entry Diagnosis of acute kidney injury/acute renal failure, or hospitalization for kidney related issue within 3 months of Screening Any renal disease or related condition actively being treated other than chronic kidney disease Any acute disease or condition being treated by medical therapy (prescription or over the counter) known to possibly impact renal function within 2 weeks of Screening History of treatment for a chronic condition with a medication that is known to have nephrotoxic potential, and after treatment, renal function/status has not been fully evaluated Uncontrolled hypertension Uncontrolled diabetes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aldafermin (NGM282)<br>Administered by subcutaneous injection | Biological: Aldafermin (NGM282)<br>* Single 3 mg dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) of aldafermin (Day 1 through Day 4) |  | 12 Days | 
| Area under the concentration-time curve from time zero extrapolated to infinity (AUC 0-infinity) of aldafermin (Day 1 through Day 4) |  | 12 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type and frequency of Adverse Events (Day 1 through Day 11) |  | 12 Days |