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Completed

NCT Number: NCT04844450

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

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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Key information

Conditions

Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Centers of America, LLC, Hollywood, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-75220795

Drug

JNJ-75220795 will be administered subcutaneously.

Placebo

Drug

Matching placebo will be administered subcutaneously.

Primary outcomes

  1. Number of Participants With Treatment-Emergent Signs and Symptoms/ Adverse Events (AEs)

    Time frame: Up to Day 182

    Number of participants with treatment-emergent signs and symptoms/adverse events (including allergic reactions/hypersensitivity and local injection site reactions) will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Treatment-emergent adverse events (TEAEs) are defined as AEs with onset or worsening on or after date of first dose of study treatment.

  2. Number of Participants With Change From Baseline in Vital Signs Abnormalities

    Time frame: Baseline, up to Day 168

    Number of participants with change from baseline in vital signs abnormalities including temperature, heart rate, respiratory rate, and blood pressure (supine) will be reported.

  3. Number of Participants With Change From Baseline in Clinical Laboratory Abnormalities

    Time frame: Baseline, up to Day 168

    Number of participants with change from baseline in clinical laboratory abnormalities including hematology, chemistry and urinalysis will be reported.

  4. Number of Participants With Change From Baseline in Physical Examination Abnormalities

    Time frame: Baseline, up to Day 168

    Number of participants with change from baseline in physical examination abnormalities will be reported.

  5. Number of Participants With Change From Baseline in Electrocardiogram (ECG) Abnormalities

    Time frame: Baseline, up to Day 168

    Number of participants with change from baseline in ECG abnormalities will be reported.

Secondary outcomes

  1. Percent Change From Baseline in Liver Fat Content

    Time frame: Baseline, weeks 6, 12, 18 and 24

    Percent change from baseline in liver fat content will be reported.

  2. Plasma Concentration of JNJ-75220795 Over Time

    Time frame: SAD: Predose, up to Day 3 and MAD: Predose, up to Day 86

    Plasma samples will be analyzed to determine concentrations of JNJ-75220795.

  3. Percentage of Participants With Treatment-emergent Anti Drug Antibodies (ADA)

    Time frame: Up to Day 168

    Percentage of participants with treatment-emergent ADA will be assessed using a validated assay for ADA analysis.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

A Double-Blind, Placebo-Controlled, Randomized, Multipart, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered JNJ-75220795

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 14, 2021
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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