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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04857606
Other study ID # 20200001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date May 24, 2021
Est. completion date July 19, 2023

Study information

Verified date November 2023
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date July 19, 2023
Est. primary completion date July 19, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AMG 609
Single dose of AMG 609 administered as a subcutaneous injection.
Placebo
Single dose of placebo administered as a subcutaneous injection.

Locations

Country Name City State
United States Translational Clinical Research LLC Aventura Florida
United States The Institute for Liver Health - Arizona Liver Health Chandler Arizona
United States ProSciento Incorporated Chula Vista California
United States Catalina Research Institute Montclair California
United States Inland Empire Liver Foundation Rialto California
United States McGuire VA Medical Center Richmond Virginia
United States Endeavor Clinical Trials San Antonio Texas
United States Pinnacle Clinical Research San Antonio Texas
United States Texas Liver Institute San Antonio Texas
United States Orange County Research Center Tustin California

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subject Incidence of Treatment-emergent Adverse Events Day 1 to Day 150
Primary Subject Incidence of Clinically Significant Change from Baseline in Laboratory Analytes Baseline to Day 150
Primary Subject Incidence of Clinically Significant Change from Baseline in Vital Signs Baseline to Day 150
Primary Subject Incidence of Clinically Significant Change from Baseline in 12-lead Electrocardiograms (ECGs) Baseline to Day 113
Secondary Maximum Observed Concentration (Cmax) of AMG 609 Up to Day 150
Secondary Time to Maximum Observed Concentration (Tmax) of AMG 609 Up to Day 150
Secondary Area Under the Concentration Time Curve (AUC) of AMG 609 Up to Day 150
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