A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Participants With Type 2 Diabetes Mellitus
Completed · Phase 2 · Has a placebo group
Conditions studied: Obesity and Diabetes Mellitus, Type 2
In brief
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.
Key facts
- Study ID
- NCT03586830
- Run by
- Janssen Research & Development, LLC
- People needed
- 196
- Starts
- 2018-06-26
- Expected to finish
- 2019-04-05
- Last updated by the study team
- 2020-01-07
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Central Research Associates, Inc. — Birmingham, Alabama, United States
- National Research Institute — Los Angeles, California, United States
- Rancho Cucamonga Clinical Trials — Rancho Cucamonga, California, United States
- Sierra Clinical Research — Roseville, California, United States
- Encompass Clinical Research — Spring Valley, California, United States
- Diablo Clinical Research, Inc. — Walnut Creek, California, United States
- Premeir Clinical Research Institute — Miami, Florida, United States
- International Research Associates, LLC — Miami, Florida, United States
- CNS HealthCare — Orlando, Florida, United States
- Translational Research Institute for Metabolism and Diabetes — Orlando, Florida, United States
- Buynak Clinical Research — Valparaiso, Indiana, United States
- Cotton-O'Neil Clinical Research Center — Topeka, Kansas, United States
- M.D. Medical Research — Oxon Hill, Maryland, United States
- AAMRC — Flint, Michigan, United States
- Alas Science Clinical Research — Henderson, Nevada, United States
- Prestige Clinical Research — Franklin, Ohio, United States
- Albert J. Weisbrot and Associates — Mason, Ohio, United States
- Clinical Research Institute of Southern Oregon, P.C. — Medford, Oregon, United States
- Clinical Research Associates of Central PA, LLC — Altoona, Pennsylvania, United States
- Heritage Valley Medical Group — Beaver, Pennsylvania, United States
- Clinical Research Associates Inc — Nashville, Tennessee, United States
- Dallas Diabetes & Endocrine Center at Medical City — Dallas, Texas, United States
- Baylor Endocrine Center — Dallas, Texas, United States
- Permian Research Foundation — Odessa, Texas, United States
- Spectrum Medical, Inc — Danville, Virginia, United States
Full record on ClinicalTrials.gov
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