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

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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.


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
Louisville, Kentucky 40213
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400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
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Warwick, RI
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164 Moorselbaan
Aalst, 9300
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Aalst,
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Boise, ID
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Cleveland, Ohio 44122
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Cleveland, OH
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Dallas, Texas 75230
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Dallas, TX
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Evansville, Indiana 47714
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Evansville, IN
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Jacksonville, Florida 32277
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Jacksonville, FL
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Manlius, New York 13104
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Manlius, NY
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14 Asylum Street
Marlborough, Massachusetts 01752
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Marlborough, MA
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Mount Pleasant, South Carolina 29464
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Mount Pleasant, SC
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New York, New York 10065
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New York, NY
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Odessa, TX
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Phoenix, Arizona 85020
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Phoenix, AZ
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Renton, Washington 98057
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Renton, WA
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Walnut creek, California 94598
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Walnut creek, CA
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Wauwatosa, Wisconsin 53226
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Wauwatosa, WI
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West Jordan, Utah 84088
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West Jordan, UT
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