Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as JNJ-64565111 Dose Level 1, Oxyntomodulin
JNJ-64565111 · 5 trials · 4 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.
Cmax is the maximum observed serum analyte concentration.
AUC \[0-infinity) is the area under the serum concentration versus time curve from time 0 to infinite time, calculated as AUClast + Clast/lambda(z) where Clast is the last observed measurable (non- below quantification limit \[BQL\]) concentration.
AUC (0-last) is the area under the serum concentration versus time curve from time 0 to time of the last measurable (non-below quantification limit \[BQL\]) concentration, calculated by linear linear trapezoidal summation.
Number of participants with gastrointestinal adverse events will be assessed. An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily have a causal relationship with the relevant investigational product.
Cmax is the maximum observed serum analyte concentration of JNJ-64565111.
AUC \[0-Last\] is the area under the serum analyte concentration versus time curve from time zero to the time of the last measurable (not below quantification limit) concentration of JNJ-64565111, calculated by linear-linear trapezoidal summation.
AUC (0-infinity) is the area under the serum analyte concentration-time curve from time zero to infinite time, calculated as AUC(last) + C(last)/lamda(z) where C(last) is the last observed measurable (not below quantification limit) concentration of JNJ-64565111.
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 |
|---|---|---|
| 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. |
| Part A: Treatment Sequence ABC: JNJ-64565111 | EXPERIMENTAL | Participants will receive Treatment A (JNJ-64565111 subcutaneous \[SC\] administration in the upper arm in fasted condition) on Day 1 of Treatment Period 1; followed by Treatment B (JNJ-64565111 SC administration in the thigh in fasted condition) on Day 1 of Treatment Period 2 and then Treatment C (JNJ-64565111 SC administration in the abdomen in fasted condition) on Day 1 of Treatment Period 3. Each treatment period will be separated by a washout Period of at least 7 days between the last pharmacokinetic (PK) sample collection and dosing on Day 1 of subsequent treatment period. |
| Part A: Treatment Sequence ACB: JNJ-64565111 | EXPERIMENTAL | Participants will receive Treatment A on Day 1 of Treatment Period 1; followed by Treatment C on Day 1 of Treatment Period 2 and then Treatment B on Day 1 of Treatment Period 3. Each treatment period will be separated by a washout Period of at least 7 days between the last PK sample collection and dosing on Day 1 of subsequent treatment period. |
| Part A: Treatment Sequence BAC: JNJ-64565111 | EXPERIMENTAL | Participants will receive Treatment B on Day 1 of Treatment Period 1; followed by Treatment A on Day 1 of Treatment Period 2 and then Treatment C on Day 1 of Treatment Period 3. Each treatment period will be separated by a washout Period of at least 7 days between the last PK sample collection and dosing on Day 1 of subsequent treatment period. |
| Part A: Treatment Sequence BCA: JNJ-64565111 | EXPERIMENTAL | Participants will receive Treatment B on Day 1 of Treatment Period 1; followed by Treatment C on Day 1 of Treatment Period 2 and then Treatment A on Day 1 of Treatment Period 3. Each treatment period will be separated by a washout Period of at least 7 days between the last PK sample collection and dosing on Day 1 of subsequent treatment period. |
| Part A: Treatment Sequence CAB: JNJ-64565111 | EXPERIMENTAL | Participants will receive Treatment C on Day 1 of Treatment Period 1; followed by Treatment A on Day 1 of Treatment Period 2 and then Treatment B on Day 1 of Treatment Period 3. Each treatment period will be separated by a washout Period of at least 7 days between the last PK sample collection and dosing on Day 1 of subsequent treatment period. |
| Part A: Treatment Sequence CBA: JNJ-64565111 | EXPERIMENTAL | Participants will receive Treatment C on Day 1 of Treatment Period 1; followed by Treatment B on Day 1 of Treatment Period 2 and then Treatment A on Day 1 of Treatment Period 3. Each treatment period will be separated by a washout Period of at least 7 days between the last PK sample collection and dosing on Day 1 of subsequent treatment period. |
| Part B: JNJ-64565111 | EXPERIMENTAL | Participants will receive a single SC ascending doses of JNJ-64565111 on Days 1, 8, 15, 22, 29 and 36. |
| Group 1: JNJ-64565111 | EXPERIMENTAL | Participants with normal renal function and no evidence of kidney damage (estimated glomerular filtration rate \[eGFR\] greater than or equal to \[\>=\] 90 milliliter/minute \[mL/min\]) will be enrolled. Participants will receive a single subcutaneous (SC) dose of JNJ-64565111 on Day 1. |
| Group 2: JNJ-64565111 | EXPERIMENTAL | Participants with mild renal impairment (eGFR 60 to less than \[\<\] 90 mL/min) will be enrolled. Participants will receive a single SC dose of JNJ-64565111 on Day 1. |
| Group 3: JNJ-64565111 | EXPERIMENTAL | Participants with moderate renal impairment (eGFR 30 to \<60 mL/min) will be enrolled. Participants will receive a single SC dose of JNJ-64565111 on Day 1. |
| Group 4: JNJ-64565111 | EXPERIMENTAL | Participants with severe renal impairment (eGFR \<30 mL/min) will be enrolled. Participants will receive a single SC dose of JNJ-64565111 on Day 1. |
| Group 5: JNJ-64565111 | EXPERIMENTAL | Participants with end-stage renal disease (requiring hemodialysis 3 times per week for at least 3 months before screening; eGFR will not be calculated) will be enrolled. Participants will receive a single SC dose of JNJ-64565111 on Day 1. |
| 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 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. |
| JNJ-64565111 | DRUG | JNJ-64565111 SC will be administered on Day 1 of Treatment Periods 1, 2 and 3 as per the assigned treatment sequence in Part A and as ascending doses on Days 1, 8, 15, 22, 29 and 36 in Part B. |
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 developed by Johnson & Johnson for metabolic conditions. It has been studied in obesity, type 2 diabetes mellitus, and chronic kidney failure. It is not an approved medicine; all clinical work to date has been in Phase 1 and Phase 2 trials, and no active trials are currently listed.
JNJ-64565111 has been studied for obesity, obesity with type 2 diabetes mellitus, type 2 diabetes mellitus, and chronic kidney failure. Trials enrolled severely obese participants with and without type 2 diabetes, plus participants with varying degrees of renal function. It remains investigational and is not an approved treatment for any of these conditions.
Johnson & Johnson, which trades under the ticker JNJ, develops JNJ-64565111. The company sponsored the clinical program for the small molecule across obesity, type 2 diabetes mellitus, and chronic kidney failure studies conducted in the United States and several European countries.
JNJ-64565111 has completed Phase 1 and Phase 2 clinical trials. Two Phase 2 studies were run, one in severely obese participants with type 2 diabetes and one in non-diabetic severely obese participants. No trials are currently active, and the drug is not approved for any indication.
Completed trials include NCT03586843, a Phase 1 study of single and multiple subcutaneous doses in overweight or obese adults; NCT03586830, a Phase 2 study in severely obese participants with type 2 diabetes; NCT03546205, a Phase 1 pharmacokinetics and safety study in adults with varying renal function; and NCT03486392, a Phase 2 study in non-diabetic severely obese participants.
Yes. JNJ-64565111 Dose Level 1 is another name used for JNJ-64565111, referring to a specific dose level within the clinical program. Searches for either name point to the same Johnson & Johnson investigational small molecule studied in obesity, type 2 diabetes, and chronic kidney failure trials.