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| ID | Type | Description | Link |
|---|---|---|---|
| 75220795NAS1001 | Other Identifier | Janssen Research & Development, LLC |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-75220795 | Drug | JNJ-75220795 will be administered subcutaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Liver Fat Content | Percent change from baseline in liver fat content will be reported. | Baseline, weeks 6, 12, 18 and 24 |
| Plasma Concentration of JNJ-75220795 Over Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Centers of America, LLC | Hollywood | Florida | 33024 | United States | ||
| Endeavor Clinical Trials, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40881642 | Derived | 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. |
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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
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Placebo | Drug | Matching placebo will be administered subcutaneously. |
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Plasma samples will be analyzed to determine concentrations of JNJ-75220795.
| 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. | Up to Day 168 |
| San Antonio |
| Texas |
| 78240 |
| United States |