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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-24

Study Completion Date

2023-07-19

Brief Summary

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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).

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Detailed Description

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Conditions

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Non-alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AMG 609

Up to 7 cohorts ranging by various dose levels.

Group Type EXPERIMENTAL

AMG 609

Intervention Type DRUG

Single dose of AMG 609 administered as a subcutaneous injection.

Placebo

Participants will receive the matching placebo.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Single dose of placebo administered as a subcutaneous injection.

Interventions

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AMG 609

Single dose of AMG 609 administered as a subcutaneous injection.

Intervention Type DRUG

Placebo

Single dose of placebo administered as a subcutaneous injection.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No