A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Participants With Type 2 Diabetes Mellitus
- Conditions
- Obesity and Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT03586830
- Lead Sponsor
- Janssen Research & Development, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 196
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description JNJ-64565111 Dose Level 2 JNJ-64565111 Dose Level 2 Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly for 12-week treatment phase. JNJ-64565111 Dose Level 1 JNJ-64565111 Dose Level 1 Participants will receive JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 12-week treatment phase. JNJ-64565111 Dose Level 3 JNJ-64565111 Dose Level 3 Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly for 12-week treatment phase. Placebo Placebo Participants will receive placebo matching to JNJ-64565111 SC once-weekly for 12-week treatment phase.
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Body Weight at Week 12 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) 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 Outcome Measures
Name Time Method Change From Baseline in Body Weight at Week 12 Baseline, Week 12 Change from baseline in body weight at Week 12 was reported.
Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Weight Loss at Week 12 Week 12 Number of participants with \>= 5 % weight loss at Week 12 was reported.
Trial Locations
- Locations (27)
Prestige Clinical Research
🇺🇸Franklin, Ohio, United States
Central Research Associates, Inc.
🇺🇸Birmingham, Alabama, United States
Premeir Clinical Research Institute
🇺🇸Miami, Florida, United States
International Research Associates, LLC
🇺🇸Miami, Florida, United States
National Research Institute
🇺🇸Los Angeles, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
Buynak Clinical Research
🇺🇸Valparaiso, Indiana, United States
Cotton-O'Neil Clinical Research Center
🇺🇸Topeka, Kansas, United States
AAMRC
🇺🇸Flint, Michigan, United States
Albert J. Weisbrot and Associates
🇺🇸Mason, Ohio, United States
Clinical Research Associates of Central PA, LLC
🇺🇸Altoona, Pennsylvania, United States
Heritage Valley Medical Group
🇺🇸Beaver, Pennsylvania, United States
Dallas Diabetes & Endocrine Center at Medical City
🇺🇸Dallas, Texas, United States
Baylor Endocrine Center
🇺🇸Dallas, Texas, United States
Spectrum Medical, Inc
🇺🇸Danville, Virginia, United States
Dominion Medical Associates, Inc.
🇺🇸Richmond, Virginia, United States
National Clinical Research
🇺🇸Richmond, Virginia, United States
Translational Research Institute for Metabolism and Diabetes
🇺🇸Orlando, Florida, United States
M.D. Medical Research
🇺🇸Oxon Hill, Maryland, United States
Alas Science Clinical Research
🇺🇸Henderson, Nevada, United States
CNS HealthCare
🇺🇸Orlando, Florida, United States
Clinical Research Institute of Southern Oregon, P.C.
🇺🇸Medford, Oregon, United States
Clinical Research Associates Inc
🇺🇸Nashville, Tennessee, United States
Sierra Clinical Research
🇺🇸Roseville, California, United States
Rancho Cucamonga Clinical Trials
🇺🇸Rancho Cucamonga, California, United States
Permian Research Foundation
🇺🇸Odessa, Texas, United States