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

NCT04844450 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10899775220795NAS1001
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Fatty Liver Disease

Outcome Measures

Primary Outcomes (5)

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

  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.

  Up to Day 182

• Number of Participants With Change From Baseline in Vital Signs Abnormalities

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

  Baseline, up to Day 168

• Number of Participants With Change From Baseline in Clinical Laboratory Abnormalities

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

  Baseline, up to Day 168

• Number of Participants With Change From Baseline in Physical Examination Abnormalities

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

  Baseline, up to Day 168

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

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

  Baseline, up to Day 168

Secondary Outcomes (3)

• Percent Change From Baseline in Liver Fat Content

  Baseline, weeks 6, 12, 18 and 24

• Plasma Concentration of JNJ-75220795 Over Time

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

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

  Up to Day 168

Study Arms (2)

Single Ascending Dose (SAD)

EXPERIMENTAL

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.

Drug: JNJ-75220795; Drug: Placebo

Multiple Ascending Dose (MAD)

EXPERIMENTAL

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.

Drug: JNJ-75220795; Drug: Placebo

Interventions

JNJ-75220795 DRUG

JNJ-75220795 will be administered subcutaneously.

Multiple Ascending Dose (MAD); Single Ascending Dose (SAD)

Placebo DRUG

Matching placebo will be administered subcutaneously.

Multiple Ascending Dose (MAD); Single Ascending Dose (SAD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (2)

Research Centers of America, LLC

Hollywood, Florida, 33024, United States

Location

Endeavor Clinical Trials, LLC

San Antonio, Texas, 78240, United States

Location

Related Publications (1)

• Wang C, Guo P, Liu X, Xu X, Zou L, Meng S, Guo Q, Wen Q, Yang C. Association Between PNPLA3 Inhibition and Gout: A Drug Target Mendelian Randomization Study. Int J Endocrinol. 2025 Aug 20;2025:6664846. doi: 10.1155/ije/6664846. eCollection 2025.

  PMID: 40881642 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 14, 2021
• Study Start: April 29, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

US (2)