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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03486392 | A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants | PHASE2 | COMPLETED | 474 | — | — | Mar 26, 2018 | Mar 8, 2019 | Feb 5, 2020 | 51 | United States, Belgium +4 |
Percent change in body weight in kilograms (kg) from baseline to Week 26 was reported.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. A TEAE was defined as an AE with an onset after the initiation study drug and before the last study drug date of the double-blind (26-week) treatment phase for plus 28 days for liraglutide participants, and plus 35 days for JNJ-64565111 and placebo participants.
| Arm | Type | Description |
|---|---|---|
| Double-Blind: JNJ-64565111 Dose Level 1 | EXPERIMENTAL | Participants will receive a JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 26-week treatment phase. |
| Double-Blind: JNJ-64565111 Dose Level 2 | EXPERIMENTAL | Participants will receive a JNJ-64565111 Dose Level 2 SC once-weekly for 26-week treatment phase. |
| Double-Blind: JNJ-64565111 Dose Level 3 | EXPERIMENTAL | Participants will receive a JNJ-64565111 Dose Level 3 SC once-weekly for 26-week treatment phase. |
| Double-Blind: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matching to JNJ-64565111 SC once-weekly for 26-week treatment phase. |
| Open-Label: 3.0 milligram (mg) Liraglutide | ACTIVE_COMPARATOR | Participant will receive once-daily doses of 0.6, 1.2, 1.8, 2.4, or 3.0 mg. The participants will receive liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1. Participants will be instructed to increase the dose of liraglutide by 0.6 mg dose increment every 7 days, up to the full dosage of 3.0 mg by Week 5. Participants will then continue on the 3.0 mg once-daily dosage until Week 26. |
| Name | Type | Description |
|---|---|---|
| JNJ-64565111 Dose Level 1 | DRUG | Participants will receive JNJ-64565111 Dose Level 1 SC once -weekly until Week 26. |
| JNJ-64565111 Dose Level 2 | DRUG | Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 26. |
| JNJ-64565111 Dose Level 3 | DRUG | Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 26. |
| Liraglutide | DRUG | Participants will receive liraglutide at a starting dose of 0.6 mg then dose will be ramped up by 0.6 mg daily until reaching 3.0 mg. Participants will then continue on the 3.0 mg once-daily dosage until Week 26. |
| Placebo | DRUG | Participants will receive matching placebo SC once-weekly until Week 26. |
Inclusion Criteria: * Body mass index (BMI) greater than or equal to (\>=) 35 to less than or equal to (\<=) 50 kilogram per square meter (kg/m\^2) at the screening visit * Stable weight (that is, change of \<= 5 percent \[%\] within 12 weeks before screening based on medical history) * Women must ...