A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants
Completed · Phase 2 · Has a placebo group
Conditions studied: Obesity
In brief
The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo after 26 weeks of treatment on the percent change in body weight from baseline and to assess the safety and tolerability, in non-diabetic severely obese participants.
Key facts
- Study ID
- NCT03486392
- Run by
- Janssen Research & Development, LLC
- People needed
- 474
- Starts
- 2018-03-26
- Expected to finish
- 2019-03-08
- Last updated by the study team
- 2020-02-05
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 square meter (kg/m\^2) at the screening visit
- Stable weight (that is, change of <= 5 percent [%] within 12 weeks before screening based on medical history)
- 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
- Woman of childbearing potential have a negative pregnancy test at screening
- Willing and able to adhere to specific the prohibitions and restrictions
You may not qualify if…
- History of obesity with a known secondary cause (for example, Cushing's disease/syndrome)
- History of Type 1 diabetes mellitus, Type 2 diabetes mellitus (T2DM), diabetic ketoacidosis (DKA), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- Has a Hemoglobin A1c (HbA1c) of >= 6.5% or fasting plasma glucose (FPG) >= 126 milligrams per deciliter (mg/dL) (>= 7.0 millimoles per liter [mmol/L]) at screening
- Screening calcitonin of >= 50 picograms per milliliter (pg/mL) personal history or family history of medullary thyroid cancer, or of multiple endocrine neoplasia syndrome type 2 (MEN 2), regardless of time prior to screening
- History of glucagonoma
Where it is running
- Diablo Clinical Research, Inc. — Walnut Creek, California, United States
- Care Partners Clinical Research — Jacksonville, Florida, United States
- Advanced Clinical Research — Boise, Idaho, United States
- Medisphere Medical Research Center, Llc — Evansville, Indiana, United States
- L-Marc Research Center — Louisville, Kentucky, United States
- Milford Emergency Associates, Inc. — Marlborough, Massachusetts, United States
- Central New York Clinical Research — Manlius, New York, United States
- Weill Cornell Medicine — New York, New York, United States
- Rapid Medical Research — Cleveland, Ohio, United States
- Omega Medical Research — Warwick, Rhode Island, United States
- Coastal Carolina Research Center — Mt. Pleasant, South Carolina, United States
- Dallas Diabetes Research Center — Dallas, Texas, United States
- Permian Research Foundation — Odessa, Texas, United States
- Advanced Clinical Research — West Jordan, Utah, United States
- Rainier Clinical Research Center — Renton, Washington, United States
- Allegiance Reserach Specialists, LLC — Wauwatosa, Wisconsin, United States
- OLV Ziekenhuis Aalst — Aalst, Belgium
- CSL Arlon — Arlon, Belgium
- UZ Antwerpen — Edegem, Belgium
- UZ Leuven — Leuven, Belgium
- CHU de Liège — Liège, Belgium
- AZ Delta — Roeselare, Belgium
- AZ Glorieux Ronse — Ronse, Belgium
- Practimed Medical Center — Tessenderlo, Belgium
- Central Phoenix Medical Clinic — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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