Clinical Trial Details
| Trial ID: | L1833 |
| Source ID: | NCT03586830 |
| Associated Drug: | Jnj-64565111 Dose Level 1 |
| Title: | A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Participants With Type 2 Diabetes Mellitus |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT03586830/results |
| Conditions: | Obesity and Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: JNJ-64565111 Dose Level 1|DRUG: JNJ-64565111 Dose Level 2|DRUG: JNJ-64565111 Dose Level 3|DRUG: Placebo |
| Outcome Measures: | 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|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|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 |
| Sponsor/Collaborators: | Sponsor: Janssen Research & Development, LLC |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 196 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2018-06-26 |
| Completion Date: | 2019-04-05 |
| Results First Posted: | 2020-01-07 |
| Last Update Posted: | 2020-01-07 |
| Locations: | Central Research Associates, Inc., Birmingham, Alabama, 35205, United States|National Research Institute, Los Angeles, California, 90057, United States|Rancho Cucamonga Clinical Trials, Rancho Cucamonga, California, 91730, United States|Sierra Clinical Research, Roseville, California, 95661, United States|Encompass Clinical Research, Spring Valley, California, 91978, United States|Diablo Clinical Research, Inc., Walnut Creek, California, 94598, United States|Premeir Clinical Research Institute, Miami, Florida, 33122, United States|International Research Associates, LLC, Miami, Florida, 33183, United States|CNS HealthCare, Orlando, Florida, 32801, United States|Translational Research Institute for Metabolism and Diabetes, Orlando, Florida, 32804, United States|Buynak Clinical Research, Valparaiso, Indiana, 46383, United States|Cotton-O'Neil Clinical Research Center, Topeka, Kansas, 66606, United States|M.D. Medical Research, Oxon Hill, Maryland, 20745, United States|AAMRC, Flint, Michigan, 48504, United States|Alas Science Clinical Research, Henderson, Nevada, 89014, United States|Prestige Clinical Research, Franklin, Ohio, 45005, United States|Albert J. Weisbrot and Associates, Mason, Ohio, 45040, United States|Clinical Research Institute of Southern Oregon, P.C., Medford, Oregon, 97504, United States|Clinical Research Associates of Central PA, LLC, Altoona, Pennsylvania, 16602, United States|Heritage Valley Medical Group, Beaver, Pennsylvania, 15009, United States|Clinical Research Associates Inc, Nashville, Tennessee, 37203, United States|Dallas Diabetes & Endocrine Center at Medical City, Dallas, Texas, 75230, United States|Baylor Endocrine Center, Dallas, Texas, 75246, United States|Permian Research Foundation, Odessa, Texas, 79761, United States|Spectrum Medical, Inc, Danville, Virginia, 24541, United States|Dominion Medical Associates, Inc., Richmond, Virginia, 23219, United States|National Clinical Research, Richmond, Virginia, 23294, United States |
| URL: | https://clinicaltrials.gov/show/NCT03586830 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
|---|