Obesity and Diabetes Mellitus, Type 2 Clinical Trial
Official title:
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
| Verified date | December 2019 |
| Source | Janssen Research & Development, LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 196 |
| Est. completion date | April 5, 2019 |
| Est. primary completion date | April 5, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Clinical Research Associates of Central PA, LLC | Altoona | Pennsylvania |
| United States | Heritage Valley Medical Group | Beaver | Pennsylvania |
| United States | Central Research Associates, Inc. | Birmingham | Alabama |
| United States | Baylor Endocrine Center | Dallas | Texas |
| United States | Dallas Diabetes & Endocrine Center at Medical City | Dallas | Texas |
| United States | Spectrum Medical, Inc | Danville | Virginia |
| United States | AAMRC | Flint | Michigan |
| United States | Prestige Clinical Research | Franklin | Ohio |
| United States | Alas Science Clinical Research | Henderson | Nevada |
| United States | National Research Institute | Los Angeles | California |
| United States | Albert J. Weisbrot and Associates | Mason | Ohio |
| United States | Clinical Research Institute of Southern Oregon, P.C. | Medford | Oregon |
| United States | International Research Associates, LLC | Miami | Florida |
| United States | Premeir Clinical Research Institute | Miami | Florida |
| United States | Clinical Research Associates Inc | Nashville | Tennessee |
| United States | Permian Research Foundation | Odessa | Texas |
| United States | CNS HealthCare | Orlando | Florida |
| United States | Translational Research Institute for Metabolism and Diabetes | Orlando | Florida |
| United States | M.D. Medical Research | Oxon Hill | Maryland |
| United States | Rancho Cucamonga Clinical Trials | Rancho Cucamonga | California |
| United States | Dominion Medical Associates, Inc. | Richmond | Virginia |
| United States | National Clinical Research | Richmond | Virginia |
| United States | Sierra Clinical Research | Roseville | California |
| United States | Encompass Clinical Research | Spring Valley | California |
| United States | Cotton-O'Neil Clinical Research Center | Topeka | Kansas |
| United States | Buynak Clinical Research | Valparaiso | Indiana |
| United States | Diablo Clinical Research, Inc. | Walnut Creek | California |
| Lead Sponsor | Collaborator |
|---|---|
| Janssen Research & Development, LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | Change From Baseline in Body Weight at Week 12 | Change from baseline in body weight at Week 12 was reported. | Baseline, Week 12 | |
| Secondary | 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 |