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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Fatty Liver Disease

Treatments: Drug: JNJ-75220795; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04844450

CR108997

75220795NAS1001 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 55 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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55 participants in 2 patient groups

Single Ascending Dose (SAD)

Experimental group

Description:

Participants in cohorts 1-5 and cohorts 3a-5a will receive subcutaneous (SC) injection of single dose (Part A) of JNJ-75220795 or matching placebo.

Treatment:

Drug: Placebo

Drug: JNJ-75220795

Multiple Ascending Dose (MAD)

Experimental group

Description:

Participants in cohorts 6-8 will receive SC injection of 2 doses (Part B) of JNJ-75220795 or matching placebo. Participants in cohorts 9-11 will receive SC injection of 4 doses (Part C) of JNJ-75220795 or matching placebo.

Treatment:

Drug: Placebo

Drug: JNJ-75220795