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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03235219 | A Phase 1b Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of JNJ-64565111 in Participants With Type 2 Diabetes Mellitus | PHASE1 | COMPLETED | 39 | — | — | Aug 1, 2017 | Feb 19, 2018 | Apr 27, 2025 | 2 | United States |
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 to 4: JNJ-64565111 or Placebo | EXPERIMENTAL | Participants in cohort 1 to 4 in a ratio of 4:1 will receive a dose of JNJ-64565111 or placebo subcutaneously on Days 1, 8, 15 and 22. Cohort 1, 2 and 3 will be dosed in parallel. Dosing for subsequent cohort 4 will be escalated based on review by the Sponsor and Principal Investigator of blinded safety, tolerability, pharmacokinetic, and (all available) pharmacodynamic data collected up to Day 29, but will not exceed from well-tolerated dose. |
| Cohort 5: JNJ-64565111 (Repeat or Lower Dose) or Placebo | EXPERIMENTAL | Participants in ratio of 4:1 will receive a dose of JNJ-64565111 or placebo subcutaneously on Days 1, 8, 15 and 22, and may be modified. The dose can be repeated or lower than a dose previously assessed as well tolerated. |
| Name | Type | Description |
|---|---|---|
| JNJ-64565111 | DRUG | Participants will receive JNJ-64565111 subcutaneously in the abdomen on Days 1, 8, 15 and 22. |
| Placebo | DRUG | Participants will receive placebo subcutaneously in the abdomen on Days 1, 8, 15 and 22. |
Inclusion Criteria: * Diagnosis of type 2 diabetes mellitus (T2DM) at least 3 months prior to Screening * Hemoglobin A1c (HbA1c) greater than or equal to (\>=) 7.0 percent (%) and lesser than or equal to (\<=)9.5% at Screening * On a stable treatment regimen for at least 3 months prior to Screening...