A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Participants With Type 2 Diabetes Mellitus
Condition: Obesity and Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: JNJ-64565111 Dose Level 1; JNJ-64565111 Dose Level 2; JNJ-64565111 Dose Level 3; Placebo
Intervention description: Participants will receive JNJ-64565111 Dose Level 1 SC once-weekly until Week 12.; Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 12.; Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 12.; Participants will receive matching placebo to JNJ-64565111 SC once-weekly until Week 12.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 196.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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