A Single and Multiple Ascending Dose Study of Subcutaneously Administered JNJ-75220795

Janssen Research & Development, LLC55 enrolled

Overview

The purpose of the study is to assess the safety and tolerability of single and multiple subcutaneous (SC) doses of JNJ-75220795.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Fatty Liver Disease

Interventions

JNJ-75220795DRUG

JNJ-75220795 will be administered subcutaneously.

PlaceboDRUG

Matching placebo will be administered subcutaneously.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants with certain genetic predisposition to non-alcoholic fatty liver disease (NAFLD) determined at screening * Presence of liver steatosis at screening * Participants on anti-hypertensive and/or lipid lowering medications and/or glucose lowering medications must be on stable dose(s) for at least 4 weeks prior to screening * Weight stable defined as no more than 5% body weight loss or gain within 3 months prior to screening and no more than 5% body weight loss or gain from screening to randomization Exclusion Criteria: * Known allergies, hypersensitivity, or intolerance to JNJ-75220795 or its excipients * History of hepatitis B surface antigen (HbsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HbsAg or anti-HCV at screening * History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening

Locations (2)

Research Centers of America, LLC

Hollywood, Florida, United States

Endeavor Clinical Trials, LLC

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Number of Participants With Treatment-Emergent Signs and Symptoms/ Adverse Events (AEs)

Number of participants with treatment-emergent signs and symptoms/adverse events (including allergic reactions/hypersensitivity and local injection site reactions) will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Treatment-emergent adverse events (TEAEs) are defined as AEs with onset or worsening on or after date of first dose of study treatment.

Time frame: Up to Day 182

Number of Participants With Change From Baseline in Vital Signs Abnormalities

Number of participants with change from baseline in vital signs abnormalities including temperature, heart rate, respiratory rate, and blood pressure (supine) will be reported.

Time frame: Baseline, up to Day 168

Number of Participants With Change From Baseline in Clinical Laboratory Abnormalities

Number of participants with change from baseline in clinical laboratory abnormalities including hematology, chemistry and urinalysis will be reported.

Time frame: Baseline, up to Day 168

Number of Participants With Change From Baseline in Physical Examination Abnormalities

Number of participants with change from baseline in physical examination abnormalities will be reported.

Time frame: Baseline, up to Day 168

Number of Participants With Change From Baseline in Electrocardiogram (ECG) Abnormalities

Number of participants with change from baseline in ECG abnormalities will be reported.

Time frame: Baseline, up to Day 168

Secondary Outcomes

Data from ClinicalTrials.gov

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