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

Sponsor

Amgen (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04857606

Collaborator

(none)

106

Enrollment

Locations

Arms

29.6

Anticipated Duration (Months)

13.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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) and to assess change in liver fat (expansion cohort only).

Condition or Disease	Intervention/Treatment	Phase
Non-alcoholic Fatty Liver Disease	Drug: AMG 609 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

May 24, 2021

Anticipated Primary Completion Date :

Nov 11, 2023

Anticipated Study Completion Date :

Nov 11, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AMG 609 Up to 8 cohorts ranging by various dose levels.	Drug: AMG 609 Single dose of AMG 609 administered as a subcutaneous injection.
Experimental: Placebo Participants will receive the matching placebo.	Drug: Placebo Single dose of placebo administered as a solution for injection.

Arm

Intervention/Treatment

Experimental: AMG 609

Up to 8 cohorts ranging by various dose levels.

Drug: AMG 609

Single dose of AMG 609 administered as a subcutaneous injection.

Experimental: Placebo

Participants will receive the matching placebo.

Drug: Placebo

Single dose of placebo administered as a solution for injection.

Outcome Measures

Primary Outcome Measures

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]
Relative Change (Percentage [%]) in Liver Fat at 12 Weeks as Measured by Magnetic Resonance Imaging Derived Proton Density Fat Fraction (MRI-PDFF) [Baseline to Week 12]

Secondary Outcome Measures

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]
Achievement of Greater than or Equal to 30 Percent (%) Relative Reduction of Liver Fat at 12 Weeks as Measured by MRI-PDFF [Baseline to Week 12]
Achievement will be measured as the number of participants who experience 30% or more relative reduction of liver fat at Week 12 compared to baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Institute for Liver Health - Arizona Liver Health	Chandler	Arizona	United States	85224
2	ProSciento, Inc.	Chula Vista	California	United States	91911
3	Inland Empire Liver Foundation	Rialto	California	United States	92377
4	Orange County Research Center	Tustin	California	United States	92780
5	Translational Clinical Research LLC	Aventura	Florida	United States	33180
6	Texas Liver Institute	San Antonio	Texas	United States	78215
7	Endeavor Clinical Trials	San Antonio	Texas	United States	78240
8	McGuire VA Medical Center	Richmond	Virginia	United States	23249