Approval Probability
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JNJ-64991524 Dose Level 1 · 2 trials · 1 indication
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
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. Treatment-emergent were events between administration of study drug and up to Day 20 that were absent before treatment or that worsened relative to pre-treatment state.
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. Treatment-emergent were events between administration of study drug and up to Day 28 that were absent before treatment or that worsened relative to pre-treatment state.
Number of participants with abnormalities in vital signs, physical examinations, ECG, cardiac telemetry and clinically significant laboratory findings will be measured.
| Arm | Type | Description |
|---|---|---|
| Part 1 (Panel 1): JNJ-55375515 and placebo | EXPERIMENTAL | Participants will receive dose level (DL) 1 of JNJ-55375515 (starting dose) or placebo on Day 1 of period 1 based on their randomization sequence 1, 2 or 3. Dose of the study medication will be escalated to DL 3 (period 2) and a maximum of DL 5 (period 3) based on the safety and tolerability profile and pharmacodynamic (PD) profile assessed at the preceding dose level. A wash-out period of at least 10 days will be maintained between study drug administrations. |
| Part 1 (Panel 2): JNJ-55375515 and placebo | EXPERIMENTAL | Participants will receive DL 2 of JNJ-55375515 (starting dose) or placebo on Day 1 of period 1 based on their randomization sequence 1, 2 or 3. Dose of the study medication will be escalated to DL 4 (period 2) and a maximum of DL 6 (period 3) based on the safety and tolerability profile and PD profile assessed at the preceding dose level. A wash-out period of at least 10 days will be maintained between study drug administrations. |
| Part 2: JNJ-55375515 and placebo | EXPERIMENTAL | Participants will randomly be assigned to one of four treatment sequences 1, 2, 3 or 4. In the first 3 sequences, participants will receive 2 doses of JNJ-55375515 and placebo. Participants assigned to sequence 4 will receive placebo only in all periods. 3 dose levels will be tested in Part 2 based on Part 1 and will not exceed those evaluated in Part 1. A wash-out period of at least 10 days will be maintained between study drug administrations in period 1, 2, 3 and 4. In period 4 (open-label pharmacokinetic (PK) assessment period) participants will be randomly assigned to one of two dose levels tested in periods 1 to 3. |
| Cohort 1:JNJ-64991524 Dose Level (DL) 1 or Placebo(SAD Part 1) | EXPERIMENTAL | Participants will receive a single oral dose (Dose level 1) of either JNJ-64991524 or placebo capsules after an overnight fast (at least 10 hours) on Day 1 of Part 1. |
| Cohort 2: JNJ-64991524 DL 2 or Placebo (SAD Part 1) | EXPERIMENTAL | Participants will receive a single oral dose (Dose level 2) of either JNJ-64991524 or placebo capsules after an overnight fast (at least 10 hours) on Day 1 of Part 1. |
| Cohort 3: JNJ-64991524 DL 3 or Placebo (SAD Part 1) | EXPERIMENTAL | Participants will receive a single oral dose (Dose level 3) of either JNJ-64991524 or placebo capsules after an overnight fast (at least 10 hours) on Day 1 of Part 1. |
| Cohort 4:JNJ-64991524 DL 4 or Placebo (SAD Part 1:Fasted-Fed) | EXPERIMENTAL | Participants will receive a single oral dose (Dose level 4) of either JNJ-64991524 or placebo capsules in a fasted condition on Day 1 and fed condition, on Day 7. |
| Cohort 5: JNJ-64991524 DL 5 or Placebo (SAD Part 1) | EXPERIMENTAL | Participants will receive a single oral dose (Dose level 5) of JNJ-64991524 or placebo after an overnight fast (at least 10 hours) on Day 1 of Part 1. |
| Cohort 6: JNJ-64991524 DL 6 or Placebo (SAD Part 1) | EXPERIMENTAL | Participants will receive a single oral dose (Dose level 6) of JNJ-64991524 or placebo after an overnight fast (at least 10 hours) on Day 1 of Part 1. |
| Cohort 1: JNJ-64991524 DL 7 or Placebo (MAD Part 2) | EXPERIMENTAL | Participants will receive an oral dose (Dose level 7) JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined based on tolerability and pharmacokinetics (PK) from Part 1. |
| Cohort 2: JNJ-64991524 DL 8 or Placebo (MAD Part 2) | EXPERIMENTAL | Participants will receive an oral dose (Dose level 8) JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined based on tolerability and PK from Part 1. |
| Cohort 3: JNJ-64991524 DL 9 or Placebo (MAD Part 2) | EXPERIMENTAL | Participants will receive an oral dose (Dose level 9) JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined based on tolerability and PK from Part 1. |
| Cohort 4: JNJ-64991524 DL 6 or Placebo (MAD Part 2) | EXPERIMENTAL | Participants will receive an oral dose (Dose level 6) of JNJ-64991524 or placebo capsules once daily for 14 days in fasted or fed condition in Part 2. Fasted/fed condition will be determined by tolerability and PK from Part 1. |
| Name | Type | Description |
|---|---|---|
| JNJ-55375515 Dose Level 1 | DRUG | Participants will receive JNJ-55375515 orally at a Dose level 1 in Part 1 of study. |
| JNJ-55375515 Dose Level 2 | DRUG | Participants will receive JNJ-55375515 orally at a Dose level 2 in Part 1 of study. |
| JNJ-55375515 Dose Level 3 | DRUG | Participants will receive JNJ-55375515 orally at a Dose level 3 in Part 1 of study. |
| JNJ-55375515 Dose Level 4 | DRUG | Participants will receive JNJ-55375515 orally at a Dose level 4 in Part 1 of study. |
| JNJ-55375515 Dose Level 5 | DRUG | Participants will receive JNJ-55375515 orally at a Dose level 5 in Part 1 of study. |
| JNJ-55375515 Dose Level 6 | DRUG | Participants will receive JNJ-55375515 orally at a Dose level 6 in Part 1 of study. |
| Placebo | DRUG | All participants will receive matching placebo orally in Part 1 and Part 2 of the study. |
| JNJ-55375515 | DRUG | Participants will receive JNJ-55375515 as per the assigned treatment in Part 2. |
| JNJ-64991524 Dose Level 1 | DRUG | Participants will receive JNJ-64991524 at a Dose Level 1 in SAD Part 1 of study. |
| JNJ-64991524 Dose Level 2 | DRUG | Participants will receive JNJ-64991524 at a Dose Level 2 in SAD Part 1 of study. |
| JNJ-64991524 Dose Level 3 | DRUG | Participants will receive JNJ-64991524 at a Dose Level 3 in SAD Part 1 of study. |
| JNJ-64991524 Dose Level 4 | DRUG | Participants will receive JNJ-64991524 at a Dose Level 4 in SAD Part 1 of study. |
| JNJ-64991524 Dose Level 5 | DRUG | Participants will receive JNJ-64991524 at a dose of Dose Level 5 in SAD Part 1 of study. |
| JNJ-64991524 Dose Level 6 | DRUG | Participants will receive JNJ-64991524 at a Dose Level 6 in SAD Part 1 and MAD part 2 of study. |
| JNJ-64991524 Dose Level 7 | DRUG | Participants will receive JNJ-64991524 at a dose of Dose Level 7 in MAD Part 2 of study for 14 days. |
| JNJ-64991524 Dose Level 8 | DRUG | Participants will receive JNJ-64991524 at a Dose Level 8 in MAD Part 2 of study for 14 days. |
| JNJ-64991524 Dose Level 9 | DRUG | Participants will receive JNJ-64991524 at a Dose Level 9 in MAD Part 2 of study for 14 days. |
Inclusion Criteria: * Body Mass Index (BMI) between 18 and 30 kilogram / square meter (kg/m\^2) inclusive (BMI=weight/height\^2) * Participant must be healthy based on clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, coagulation or urinalysi...
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.