Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Obesity
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 tol...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2019
Estimated Enrollment :
474 Patients enrolled
Trial Details
Trial ID
NCT03486392
Start Date
March 26 2018
End Date
March 8 2019
Last Update
February 5 2020
Active Locations (51)
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1
Central Phoenix Medical Clinic
Phoenix, Arizona, United States, 85020
2
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
3
Care Partners Clinical Research
Jacksonville, Florida, United States, 32277
4
Advanced Clinical Research
Boise, Idaho, United States, 83642