A Study of JNJ-75220795 in Japanese Participants

JRCT ID: jRCT2071210066

Registered date:28/09/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Fatty Liver
• Date of first enrollment: 25/05/2022
• Target sample size: 27
• Study type: Interventional

Intervention(s)

Cohort 1: JNJ-75220795 or Placebo
Participants will receive single subcutaneous (SC) dose of JNJ-75220795 Dose 1 or matching placebo on Day 1 in Cohort 1.

Cohort 2: JNJ-75220795 or Placebo
Participants will receive single SC dose of JNJ-75220795 Dose 2 or matching placebo on Day 1 in Cohort 2.

Outcome(s)

Primary Outcome

Number of Participants with Treatment-emergent Signs and Symptoms/Adverse Events (AEs)
Number of Participants With Change From Baseline
- Vital Signs Abnormalities
- Clinical Laboratory Abnormalities
- Physical Examination Abnormalities
- Electrocardiogram (ECG) Abnormalities

Secondary Outcome

Percent Change in Liver Fat Content Measured by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
Maximum Observed Plasma Concentration (Cmax) of JNJ-75220795
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-75220795
Apparent Elimination Half-Life (t1/2) of JNJ-75220795
Area Under the Plasma Concentration Time Curve of JNJ-75220795 from Time Zero to Infinite time (AUC [0-Infinity])
Area Under the Plasma Concentration versus Time Curve of JNJ-75220795 from Time Zero to Time of the Last Measurable Concentration (AUC [0-Last])
Total Apparent Clearance (CL/F) of JNJ-75220795
Apparent Volume of Distribution (Vd/F) of JNJ-75220795
Number of Participants with Treatment Emergent Anti-drug Antibody (ADA)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Nakano Masayoshi
• Secondary ID(s): NCT05039710