A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants
Status: | Completed |
---|---|
Conditions: | Obesity Weight Loss |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 4/6/2019 |
Start Date: | March 26, 2018 |
End Date: | March 8, 2019 |
A Randomized, Double-blind Placebo-controlled and Open-label Active-controlled, Parallel-group, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Subjects
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.
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.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
18
sites
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