A Phase 1 interventional study of JNJ-75220795 and Placebo in Fatty Liver Disease, sponsored by Janssen Research & Development, LLC. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment
The purpose of the study is to assess the safety and tolerability of single and multiple subcutaneous (SC) doses of JNJ-75220795.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 55 is close to the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
JNJ-75220795 will be administered subcutaneously.
Matching placebo will be administered subcutaneously.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, up to Day 168
Percent Change From Baseline in Liver Fat Content
Percent change from baseline in liver fat content will be reported.
Time frame: Baseline, weeks 6, 12, 18 and 24
Plasma Concentration of JNJ-75220795 Over Time
Plasma samples will be analyzed to determine concentrations of JNJ-75220795.
Time frame: SAD: Predose, up to Day 3 and MAD: Predose, up to Day 86
Percentage of Participants With Treatment-emergent Anti Drug Antibodies (ADA)
Percentage of participants with treatment-emergent ADA will be assessed using a validated assay for ADA analysis.
Time frame: Up to Day 168
Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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