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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-29

Study Completion Date

2023-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Single Ascending Dose (SAD)

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.

Group Type EXPERIMENTAL

JNJ-75220795

Intervention Type DRUG

JNJ-75220795 will be administered subcutaneously.

Placebo

Intervention Type DRUG

Matching placebo will be administered subcutaneously.

Multiple Ascending Dose (MAD)

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.

Group Type EXPERIMENTAL

JNJ-75220795

Intervention Type DRUG

JNJ-75220795 will be administered subcutaneously.

Placebo

Intervention Type DRUG

Matching placebo will be administered subcutaneously.

Interventions

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JNJ-75220795

JNJ-75220795 will be administered subcutaneously.

Intervention Type DRUG

Placebo

Matching placebo will be administered subcutaneously.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No