Fatty Liver Disease
Conditions
Brief summary
The purpose of the study is to assess the safety and tolerability of single and multiple subcutaneous (SC) doses of JNJ-75220795.
Interventions
DRUGJNJ-75220795
JNJ-75220795 will be administered subcutaneously.
DRUGPlacebo
Matching placebo will be administered subcutaneously.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Change From Baseline in Electrocardiogram (ECG) Abnormalities | Baseline, up to Day 168 | Number of participants with change from baseline in ECG abnormalities will be reported. |
| Number of Participants With Change From Baseline in Vital Signs Abnormalities | 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. |
| Number of Participants With Change From Baseline in Clinical Laboratory Abnormalities | Baseline, up to Day 168 | Number of participants with change from baseline in clinical laboratory abnormalities including hematology, chemistry and urinalysis will be reported. |
| Number of Participants With Change From Baseline in Physical Examination Abnormalities | Baseline, up to Day 168 | Number of participants with change from baseline in physical examination abnormalities will be reported. |
| Number of Participants With Treatment-Emergent Signs and Symptoms/ Adverse Events (AEs) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration of JNJ-75220795 Over Time | SAD: Predose, up to Day 3 and MAD: Predose, up to Day 86 | Plasma samples will be analyzed to determine concentrations of JNJ-75220795. |
| Percentage of Participants With Treatment-emergent Anti Drug Antibodies (ADA) | Up to Day 168 | Percentage of participants with treatment-emergent ADA will be assessed using a validated assay for ADA analysis. |
| Percent Change From Baseline in Liver Fat Content | Baseline, weeks 6, 12, 18 and 24 | Percent change from baseline in liver fat content will be reported. |
Countries
United States
Outcome results
None listed