A Study of JNJ-75220795 in Japanese Participants

NCT05039710 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: CR10908175220795NAS1002
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 4

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.

Conditions

Fatty Liver

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Baseline, Up to Day 168

Secondary Outcomes (9)

• 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

• Maximum Observed Plasma Concentration (Cmax) of JNJ-75220795

  Predose up to 48 hours postdose (up to Day 3)

• Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-75220795

  Predose up to 48 hours postdose (up to Day 3)

• Apparent Elimination Half-Life (t1/2) of JNJ-75220795

  Predose up to 48 hours postdose (up to Day 3)

• 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)

Study Arms (2)

Cohort 1: JNJ-75220795 or Placebo

EXPERIMENTAL

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

Drug: JNJ-75220795; Other: Placebo

Cohort 2: JNJ-75220795 or Placebo

EXPERIMENTAL

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

Drug: JNJ-75220795; Other: Placebo

Interventions

JNJ-75220795 DRUG

JNJ-75220795 will be administered as SC injection.

Cohort 1: JNJ-75220795 or Placebo; Cohort 2: JNJ-75220795 or Placebo

Placebo OTHER

Matching placebo will be administered as SC injection.

Cohort 1: JNJ-75220795 or Placebo; Cohort 2: JNJ-75220795 or Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (4)

Souseikai Fukuoka Mirai Hospital

Fukuoka, 813-0017, Japan

Location

Medical Corporation Heishinkai ToCROM Clinic

Shinjuku-ku, 160-0008, Japan

Location

Heishinkai TOCROM Clinic

Suita, 565-0853, Japan

Location

Sumida Hospital

Tokyo, 130-0004, Japan

Location

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 9, 2021
• Study Start: November 8, 2021
• Primary Completion: February 17, 2023
• Study Completion: February 17, 2023
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

JP (4)