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Study Complete
Sponsor ID
20200001

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

Sponsor ID
20200001
Clinicaltrials.gov ID
NCT04857606
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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).

Additional Study Details

Phase
Phase 1
Product
AMG 609
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
47
Additional Study Details

Protocol Summary

Primary Outcome Measures

Subject Incidence of Treatment-emergent Adverse Events

Timeframe: Day 1 to Day 150

Subject Incidence of Clinically Significant Change from Baseline in Laboratory Analytes

Timeframe: Baseline to Day 150

Subject Incidence of Clinically Significant Change from Baseline in Vital Signs

Timeframe: Baseline to Day 150

Subject Incidence of Clinically Significant Change from Baseline in 12-lead Electrocardiograms (ECGs)

Timeframe: Baseline to Day 113

Secondary Outcome Measures

Maximum Observed Concentration (Cmax) of AMG 609

Timeframe: Up to Day 150

Time to Maximum Observed Concentration (Tmax) of AMG 609

Timeframe: Up to Day 150

Area Under the Concentration Time Curve (AUC) of AMG 609

Timeframe: Up to Day 150

Locations

Location
Status
Contact Us
Location
Translational Clinical Research LLC
Aventura, FL, United States, 33180
Status
Recruiting
Location
Orange County Research Center
Tustin, CA, United States, 92780
Status
Recruiting
Location
Texas Liver Institute
San Antonio, TX, United States, 78215
Status
Recruiting
Location
ProSciento Incorporated
Chula Vista, CA, United States, 91911
Status
Recruiting
Location
The Institute for Liver Health - Arizona Liver Health
Chandler, AZ, United States, 85224
Status
Recruiting
Location
Inland Empire Liver Foundation
Rialto, CA, United States, 92377
Status
Recruiting
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Study Info
Age
18 - 70 Years
Condition
  • Fatty Liver Disease
    • Sex
    All
    Trial Dates
    May 2021 - Jul 2023
    Inclusion and Exclusion Criteria
    • 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.