Single Ascending Dose of AMG 609 in Participants With Non-alcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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This study aims to assess the safety and tolerability of AMG 609 when administered subcutaneously as single doses in participants with non-alcoholic fatty liver disease (NAFLD).

Official Title
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A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 609 in Subjects With Non-alcoholic Fatty Liver Disease

Conditions
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Non-alcoholic Fatty Liver Disease

Intervention / Treatment
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* Drug: AMG 609
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Men and women age ≥ 18 to ≤ 70 years of age at the time of signing the informed consent Body mass index (BMI) of ≥ 27 kg/m2 to ≤ 45.0 kg/m2 Liver steatosis, measured by MRI-PDFF, greater than 8% Exclusion Criteria Evidence of other liver disease (eg, viral hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, autoimmune chronic hepatitis, Wilson's disease, alpha-1 anti-trypsin deficiency, haemochromatosis, drug-induced liver injury, bile duct obstruction, known or suspected hepatocellular carcinoma). Significantly elevated LFTs (more than 1.5x ULN) Uncontrolled diabetes (HgbA1c > 9%) or uncontrolled hypertension. History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers occurring more than 5 years prior to randomization or 3 years prior to randomization for basal cell carcinoma. Females of reproductive potential.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMG 609<br>Up to 7 cohorts ranging by various dose levels. | Drug: AMG 609<br>* Single dose of AMG 609 administered as a subcutaneous injection.<br>|
| Experimental: Placebo<br>Participants will receive the matching placebo. | Drug: Placebo<br>* Single dose of placebo administered as a subcutaneous injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Incidence of Treatment-emergent Adverse Events |  | Day 1 to Day 150 | 
| Subject Incidence of Clinically Significant Change from Baseline in Laboratory Analytes |  | Baseline to Day 150 | 
| Subject Incidence of Clinically Significant Change from Baseline in Vital Signs |  | Baseline to Day 150 | 
| Subject Incidence of Clinically Significant Change from Baseline in 12-lead Electrocardiograms (ECGs) |  | Baseline to Day 113 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Concentration (Cmax) of AMG 609 |  | Up to Day 150 | 
| Time to Maximum Observed Concentration (Tmax) of AMG 609 |  | Up to Day 150 | 
| Area Under the Concentration Time Curve (AUC) of AMG 609 |  | Up to Day 150 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single ascending dose, NAFLD, AMG 609