Clinical trial NCT04857606: Single Ascending Dose of AMG 609 in Participants With Non-alcoholic Fatty Liver Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-alcoholic Fatty Liver Disease
Keywords: Single ascending dose
NAFLD
AMG 609
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2021-04-23
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief 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).


Eligibility 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.

Primary outcomes:
measure: Subject Incidence of Treatment-emergent Adverse Events
timeFrame: Day 1 to Day 150
measure: Subject Incidence of Clinically Significant Change from Baseline in Laboratory Analytes
timeFrame: Baseline to Day 150
measure: Subject Incidence of Clinically Significant Change from Baseline in Vital Signs
timeFrame: Baseline to Day 150
measure: Subject Incidence of Clinically Significant Change from Baseline in 12-lead Electrocardiograms (ECGs)
timeFrame: Baseline to Day 113
Secondary outcomes:
measure: Maximum Observed Concentration (Cmax) of AMG 609
timeFrame: Up to Day 150
measure: Time to Maximum Observed Concentration (Tmax) of AMG 609
timeFrame: Up to Day 150
measure: Area Under the Concentration Time Curve (AUC) of AMG 609
timeFrame: Up to Day 150
Other outcomes:
Locations:
city: Chandler
country: United States
facility: The Institute for Liver Health - Arizona Liver Health
state: Arizona
city: Chula Vista
country: United States
facility: ProSciento Incorporated
state: California
city: Montclair
country: United States
facility: Catalina Research Institute
state: California
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Aventura
country: United States
facility: Translational Clinical Research LLC
state: Florida
city: San Antonio
country: United States
facility: Texas Liver Institute
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Clinical Research
state: Texas
city: Richmond
country: United States
facility: McGuire VA Medical Center
state: Virginia
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: