A Study of JNJ-75220795 in Japanese Participants

Janssen (J&J Innovative Medicine)

Status and phase: Terminated; Phase 1

Conditions: Fatty Liver

Treatments: Drug: JNJ-75220795; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05039710

CR109081

75220795NAS1002 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 9 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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9 participants in 2 patient groups

Cohort 1: JNJ-75220795 or Placebo

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: JNJ-75220795

Cohort 2: JNJ-75220795 or Placebo

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: JNJ-75220795