A Single and Multiple Ascending Dose Study of Subcutaneously Administered JNJ-75220795

• Status: Recruiting
• Trial end date: 2022-11-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to assess the safety and tolerability of single and multiple subcutaneous (SC) doses of JNJ-75220795.

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

Details

• Lead Sponsor: Janssen Research & Development, LLC

Criteria

Inclusion Criteria:

• Participants with certain genetic predisposition 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

• Weight stable defined as no more than 5% body weight loss or gain within 3 months prior to screening and no more than 5% body weight loss or gain from screening to randomization

Exclusion Criteria:

• Known allergies, hypersensitivity, or intolerance to JNJ-75220795 or its 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

• History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening