Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04844450 | A Single and Multiple Ascending Dose Study of Subcutaneously Administered JNJ-75220795 | PHASE1 | COMPLETED | 55 | — | — | Apr 29, 2021 | Mar 31, 2023 | Mar 30, 2025 | 2 | United States |
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.
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 including hematology, chemistry and urinalysis will be reported.
Number of participants with change from baseline in physical examination abnormalities will be reported.
Number of participants with change from baseline in ECG abnormalities will be reported.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| JNJ-75220795 | DRUG | JNJ-75220795 will be administered subcutaneously. |
| Placebo | DRUG | Matching placebo will be administered subcutaneously. |
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...