Fatty Liver
Conditions
Brief summary
The purpose of this study is to assess the safety and tolerability of single subcutaneous (SC) dose of JNJ-75220795 in Japanese participants.
Interventions
DRUGJNJ-75220795
JNJ-75220795 will be administered as SC injection.
OTHERPlacebo
Matching placebo will be administered as SC injection.
Sponsors
Janssen Pharmaceutical K.K.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Treatment-emergent Signs and Symptoms/Adverse Events (AEs) | Up to Day 168 | 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. |
| Number of Participants With Change From Baseline in Vital Signs Abnormalities | Baseline, Up to Day 168 | Number of participants with change from baseline in vital signs abnormalities including body temperature (axillary), pulse, respiratory rate and blood pressure will be reported. |
| Number of Participants With Change From Baseline in Clinical Laboratory Abnormalities | Baseline, Up to Day 168 | Number of participants with change from baseline in clinical laboratory abnormalities including hematology, serum chemistry and urinalysis will be reported. |
| Number of Participants With Change From Baseline in Physical Examination Abnormalities | Baseline, Up to Day 168 | Number of participants with change from baseline in physical examination abnormalities will be reported. |
| Number of Participants With Change From Baseline in Electrocardiogram (ECG) Abnormalities | Baseline, Up to Day 168 | Number of participants with change from baseline in ECG abnormalities will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration versus Time Curve of JNJ-75220795 from Time Zero to Time of the Last Measurable Concentration (AUC [0-Last]) | Predose up to 48 hours postdose (up to Day 3) | AUC (0-Last) is defined as area under the plasma concentration versus time curve of JNJ-75220795 from time zero to time of the last measurable concentration. |
| Total Apparent Clearance (CL/F) of JNJ-75220795 | Predose up to 48 hours postdose (up to Day 3) | CL/F is defined as total apparent clearance of JNJ-75220795. |
| Percent Change in Liver Fat Content Measured by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) | From Baseline to Weeks 6, 12, 18, and 24 | Percent change in liver fat content as measured by MRI-PDFF will be reported. |
| Number of Participants with Treatment Emergent Anti-drug Antibody (ADA) | Up to Day 168 | Number of participants with treatment emergent ADA will be reported. |
| Apparent Volume of Distribution (Vd/F) of JNJ-75220795 | Predose up to 48 hours postdose (up to Day 3) | Vd/F is defined as apparent volume of distribution of JNJ-75220795. |
| Maximum Observed Plasma Concentration (Cmax) of JNJ-75220795 | Predose up to 48 hours postdose (up to Day 3) | Cmax of JNJ-75220795 will be reported. |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-75220795 | Predose up to 48 hours postdose (up to Day 3) | Tmax of JNJ-75220795 will be reported. |
| Apparent Elimination Half-Life (t1/2) of JNJ-75220795 | Predose up to 48 hours postdose (up to Day 3) | t1/2 is defined as apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve. |
| Area Under the Plasma Concentration Time Curve of JNJ-75220795 from Time Zero to Infinite time (AUC [0-Infinity]) | Predose up to 48 hours postdose (up to Day 3) | AUC (0-Infinity) is defined as the area under the plasma concentration versus time curve of JNJ-75220795 from time zero to infinite time. |
Countries
Japan
Outcome results
None listed