A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Participants With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo in severely obese Type 2 Diabetes Mellitus (T2DM) participants after 12 weeks of treatment on: the percentage change in body weight from baseline and safety and tolerability.

Official Title
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A Randomized, Double-blind Placebo-controlled, Parallel-group, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Subjects With Type 2 Diabetes Mellitus

Conditions
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Obesity and Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: JNJ-64565111 Dose Level 1
* Drug: JNJ-64565111 Dose Level 2
* Drug: JNJ-64565111 Dose Level 3
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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) Hemoglobin A1c of >= 6.5% and <= 9.5% at screening and meets one of the inclusion criteria as: (a) on diet and exercise alone >= 12 weeks prior to screening; (b) on stable dose of single oral antihyperglycemic agent (AHA) or dual-combination oral AHAs for >= 12 weeks prior to screening Women must be either: (a) Postmenopausal, or (b) Permanently sterilized or otherwise be incapable of pregnancy, or (c) Heterosexually active and practicing a highly effective method of birth control, or (d) Not heterosexually active Willing and able to adhere to specific the prohibitions and restrictions Exclusion Criteria: History of obesity with a known secondary cause (example, Cushing's disease/syndrome) History of Type 1 diabetes mellitus, diabetic ketoacidosis, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy Fasting C-peptide less than (<) 0.7 nanogram per milliliter (ng/mL) at screening Fasting fingerstick glucose of >= 270 milligram per deciliter (mg/dL) (>=15 millimoles per liter [mmol/L]) on Day 1 Ongoing, inadequately controlled thyroid disorder as assessed by the investigator's review of the participant's medical history. Participants taking thyroid hormone replacement therapy must be on stable doses for at least 6 weeks before the screening visit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JNJ-64565111 Dose Level 1<br>Participants will receive JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 12-week treatment phase. | Drug: JNJ-64565111 Dose Level 1<br>* Participants will receive JNJ-64565111 Dose Level 1 SC once-weekly until Week 12.<br>|
| Experimental: JNJ-64565111 Dose Level 2<br>Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly for 12-week treatment phase. | Drug: JNJ-64565111 Dose Level 2<br>* Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 12.<br>|
| Experimental: JNJ-64565111 Dose Level 3<br>Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly for 12-week treatment phase. | Drug: JNJ-64565111 Dose Level 3<br>* Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 12.<br>|
| Placebo Comparator: Placebo<br>Participants will receive placebo matching to JNJ-64565111 SC once-weekly for 12-week treatment phase. | Drug: Placebo<br>* Participants will receive matching placebo to JNJ-64565111 SC once-weekly until Week 12.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Body Weight at Week 12 | Percent change from baseline in body weight in kilograms (kg) at Week 12 was reported. | Baseline, Week 12 | 
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 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. | Up to 16 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Body Weight at Week 12 | Change from baseline in body weight at Week 12 was reported. | Baseline, Week 12 | 
| Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Weight Loss at Week 12 | Number of participants with >= 5 % weight loss at Week 12 was reported. | Week 12 |