A Study of JNJ-75220795 in Japanese Participants

Phase 1TerminatedNCT05039710

Janssen Pharmaceutical K.K.9 enrolled

Overview

The purpose of this study is to assess the safety and tolerability of single subcutaneous (SC) dose of JNJ-75220795 in Japanese participants.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Fatty Liver

Interventions

JNJ-75220795DRUG

JNJ-75220795 will be administered as SC injection.

PlaceboOTHER

Matching placebo will be administered as SC injection.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants with certain genetic predispositions 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 * Body mass index between 18 kilograms per meter square (kg/m\^2) and 40 kg/m\^2 inclusive, and body weight stable defined as no more than 5 percent (%) body weight loss or gain within 3 months prior to screening (based on participant's report) and no more than 5% body weight loss or gain from screening to randomization Exclusion Criteria: * Known allergies, hypersensitivity, or intolerance to 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. And/or history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV or syphilis at screening * Participants with clinical or biochemical (international normalized ratio \[INR\] greater than \[\>\] 1.2, or platelet count less than \[\<\] lower limits of normal \[LLN\]) evidence of hepatic decompensation at screening or baseline * Estimated glomerular filtration rate (eGFR) by Japanese eGFR formula below 60 milliliters per minute \[mL/min\] at screening * Thyroid stimulating hormone (TSH) levels, free triiodothyronine (FT3) and free thyroxine (FT4) outside normal limits of the clinical laboratory's reference range at screening

Locations (4)

Souseikai Fukuoka Mirai Hospital

Fukuoka, Japan

Medical Corporation Heishinkai ToCROM Clinic

Shinjuku-ku, Japan

Heishinkai TOCROM Clinic

Suita, Japan

Sumida Hospital

Tokyo, Japan

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 168

Number of Participants With Change From Baseline in Vital Signs Abnormalities

Number of participants with change from baseline in vital signs abnormalities including body temperature (axillary), pulse, respiratory rate and blood pressure 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, serum 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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