Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-64565111 Dose Level 1 · 2 trials · 2 indications
Percent change from baseline in body weight in kilograms (kg) at Week 12 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. An TEAE is defined as an AE with an onset after the initiation study medication and before the last study medication date of the double-blind (12-Week) treatment phase plus 35 Days.
Percent change in body weight in kilograms (kg) from baseline to Week 26 was reported.
| Arm | Type | Description |
|---|---|---|
| JNJ-64565111 Dose Level 1 | EXPERIMENTAL | Participants will receive JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 12-week treatment phase. |
| JNJ-64565111 Dose Level 2 | EXPERIMENTAL | Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly for 12-week treatment phase. |
| JNJ-64565111 Dose Level 3 | EXPERIMENTAL | Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly for 12-week treatment phase. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matching to JNJ-64565111 SC once-weekly for 12-week treatment phase. |
| 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 12. |
| JNJ-64565111 Dose Level 2 | DRUG | Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 12. |
| JNJ-64565111 Dose Level 3 | DRUG | Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 12. |
| Placebo | DRUG | Participants will receive matching placebo to JNJ-64565111 SC once-weekly until Week 12. |
| 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. |
Inclusion Criteria: * Body Mass Index (BMI) greater than or equal to (\>=) 35 to less than or equal to (\<=) 50 kilogram per meter square (kg/m\^2) at screening * Stable weight (that is, change of \<= 5 percent \[%\] within 12 weeks before screening based on medical or participant reported history)...
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JNJ-64565111 is an investigational small molecule being studied for the treatment of obesity and for obesity with type 2 diabetes mellitus. It has been evaluated in clinical trials involving severely obese participants, including those with type 2 diabetes, as well as in healthy volunteers for safety and tolerability studies.
JNJ-64565111 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The company has sponsored clinical trials to investigate the safety, tolerability, pharmacokinetics, and efficacy of this investigational drug.
JNJ-64565111 has completed Phase 2 clinical trials for obesity and for obesity with type 2 diabetes mellitus. These trials were randomized, double-blind, and placebo-controlled. The drug is investigational and has not been approved by regulatory authorities, as it remains in clinical development.
JNJ-64565111 has been studied in two completed Phase 2 trials: NCT03486392 evaluated its safety and efficacy in non-diabetic severely obese participants, and NCT03586830 evaluated it in severely obese participants with type 2 diabetes mellitus. Both trials were randomized, double-blind, and placebo-controlled.
No, JNJ-64565111 is distinct from JNJ-64991524 and JNJ-55375515. Those are separate investigational compounds studied in Phase 1 trials in healthy participants. JNJ-64565111 was specifically evaluated in Phase 2 trials for obesity and obesity with type 2 diabetes, while the others were assessed for safety and tolerability in healthy volunteers.
JNJ-64565111 has completed Phase 2 clinical development, with two trials finished: one in severely obese non-diabetic participants and one in severely obese participants with type 2 diabetes. The drug is not approved and remains investigational, with no active trials currently listed for this compound.