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
Overview
- Phase
- Phase 2
- Intervention
- JNJ-64565111 Dose Level 1
- Conditions
- Obesity and Diabetes Mellitus, Type 2
- Sponsor
- Janssen Research & Development, LLC
- Enrollment
- 196
- Locations
- 27
- Primary Endpoint
- Percent Change From Baseline in Body Weight at Week 12
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
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
Arms & Interventions
JNJ-64565111 Dose Level 1
Participants will receive JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 12-week treatment phase.
Intervention: JNJ-64565111 Dose Level 1
JNJ-64565111 Dose Level 2
Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly for 12-week treatment phase.
Intervention: JNJ-64565111 Dose Level 2
JNJ-64565111 Dose Level 3
Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly for 12-week treatment phase.
Intervention: JNJ-64565111 Dose Level 3
Placebo
Participants will receive placebo matching to JNJ-64565111 SC once-weekly for 12-week treatment phase.
Intervention: Placebo
Outcomes
Primary Outcomes
Percent Change From Baseline in Body Weight at Week 12
Time Frame: Baseline, Week 12
Percent change from baseline in body weight in kilograms (kg) at Week 12 was reported.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to 16 Weeks
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.
Secondary Outcomes
- Change From Baseline in Body Weight at Week 12(Baseline, Week 12)
- Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Weight Loss at Week 12(Week 12)