Non-alcoholic Fatty Liver Disease Clinical Trial
Official title:
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
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 |
Verified date | November 2023 |
Source | Amgen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Amgen |
United States,
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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