A Study of JNJ-75220795 in Japanese Participants

Phase 1

Terminated

• Conditions: Fatty Liver
• Interventions: Drug: JNJ-75220795; Other: Placebo

• Registration Number: NCT05039710
• Lead Sponsor: Janssen Pharmaceutical K.K.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-01
• Study First Submitted QC: 2021-09-01
• Study First Posted: 2021-09-09
• Study Start: 2021-11-08
• Primary Completion: 2023-02-17
• Study Completion: 2023-02-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 2: JNJ-75220795 or Placebo	JNJ-75220795	Participants will receive single SC dose of JNJ-75220795 Dose 2 or matching placebo on Day 1 in Cohort 2.
Cohort 1: JNJ-75220795 or Placebo	JNJ-75220795	Participants will receive single subcutaneous (SC) dose of JNJ-75220795 Dose 1 or matching placebo on Day 1 in Cohort 1.
Cohort 1: JNJ-75220795 or Placebo	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	Placebo	Participants will receive single SC dose of JNJ-75220795 Dose 2 or matching placebo on Day 1 in Cohort 2.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.
Number of Participants with Treatment Emergent Anti-drug Antibody (ADA)	Up to Day 168	Number of participants with treatment emergent ADA will be reported.

Trial Locations

Locations (4)

Medical Corporation Heishinkai ToCROM Clinic; 🇯🇵 Shinjuku-ku, Japan

Heishinkai TOCROM Clinic; 🇯🇵 Suita-city, Japan

Souseikai Fukuoka Mirai Hospital; 🇯🇵 Fukuoka-shi, Japan

Sumida Hospital; 🇯🇵 Tokyo, Japan