A Study of JNJ-75220795 in Japanese Participants

• Status: Not yet recruiting
• Trial end date: 2022-11-28
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.

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

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