Status:
COMPLETED
A Single and Multiple Ascending Dose Study of Subcutaneously Administered JNJ-75220795
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Fatty Liver Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to assess the safety and tolerability of single and multiple subcutaneous (SC) doses of JNJ-75220795.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04844450
Start Date
April 29 2021
End Date
March 31 2023
Last Update
March 30 2025
Active Locations (2)
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1
Research Centers of America, LLC
Hollywood, Florida, United States, 33024
2
Endeavor Clinical Trials, LLC
San Antonio, Texas, United States, 78240